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1.  The effects of augmented visual feedback during balance training in Parkinson’s disease: study design of a randomized clinical trial 
BMC Neurology  2013;13:137.
Background
Patients with Parkinson’s disease often suffer from reduced mobility due to impaired postural control. Balance exercises form an integral part of rehabilitative therapy but the effectiveness of existing interventions is limited. Recent technological advances allow for providing enhanced visual feedback in the context of computer games, which provide an attractive alternative to conventional therapy. The objective of this randomized clinical trial is to investigate whether a training program capitalizing on virtual-reality-based visual feedback is more effective than an equally-dosed conventional training in improving standing balance performance in patients with Parkinson’s disease.
Methods/design
Patients with idiopathic Parkinson’s disease will participate in a five-week balance training program comprising ten treatment sessions of 60 minutes each. Participants will be randomly allocated to (1) an experimental group that will receive balance training using augmented visual feedback, or (2) a control group that will receive balance training in accordance with current physical therapy guidelines for Parkinson’s disease patients. Training sessions consist of task-specific exercises that are organized as a series of workstations. Assessments will take place before training, at six weeks, and at twelve weeks follow-up. The functional reach test will serve as the primary outcome measure supplemented by comprehensive assessments of functional balance, posturography, and electroencephalography.
Discussion
We hypothesize that balance training based on visual feedback will show greater improvements on standing balance performance than conventional balance training. In addition, we expect that learning new control strategies will be visible in the co-registered posturographic recordings but also through changes in functional connectivity.
Trial registration
ISRCTN: ISRCTN47046299
doi:10.1186/1471-2377-13-137
PMCID: PMC3852133  PMID: 24093506
Randomized clinical trial; Parkinson’s disease; Physical therapy; Balance training; Postural control; Virtual reality; Visual feedback; Electroencephalography; Posturography; Force plate
2.  Robot-assisted walking training for individuals with Parkinson’s disease: a pilot randomized controlled trial 
BMC Neurology  2013;13:50.
Background
Over the last years, the introduction of robotic technologies into Parkinson’s disease rehabilitation settings has progressed from concept to reality. However, the benefit of robotic training remains elusive. This pilot randomized controlled observer trial is aimed at investigating the feasibility, the effectiveness and the efficacy of new end-effector robot training in people with mild Parkinson’s disease.
Methods
Design. Pilot randomized controlled trial.
Setting. Robot assisted gait training (EG) compared to treadmill training (CG).
Participants. Twenty cognitively intact participants with mild Parkinson’s disease and gait disturbance.
Interventions. The EG underwent a rehabilitation programme of robot assisted walking for 40 minutes, 5 times a week for 4 weeks. The CG received a treadmill training programme for 40 minutes, 5 times a week for 4 weeks.
Main outcome measures. The outcome measure of efficacy was recorded by gait analysis laboratory. The assessments were performed at the beginning (T0) and at the end of the treatment (T1). The main outcome was the change in velocity. The feasibility of the intervention was assessed by recording exercise adherence and acceptability by specific test.
Results
Robot training was feasible, acceptable, safe, and the participants completed 100% of the prescribed training sessions. A statistically significant improvement in gait index was found in favour of the EG (T0 versus T1). In particular, the statistical analysis of primary outcome (gait speed) using the Friedman test showed statistically significant improvements for the EG (p = 0,0195). The statistical analysis performed by Friedman test of Step length left (p = 0,0195) and right (p = 0,0195) and Stride length left (p = 0,0078) and right (p = 0,0195) showed a significant statistical gain. No statistically significant improvements on the CG were found.
Conclusions
Robot training is a feasible and safe form of rehabilitative exercise for cognitively intact people with mild PD. This original approach can contribute to increase a short time lower limb motor recovery in idiopathic PD patients. The focus on the gait recovery is a further characteristic that makes this research relevant to clinical practice. On the whole, the simplicity of treatment, the lack of side effects, and the positive results from patients support the recommendation to extend the use of this treatment. Further investigation regarding the long-time effectiveness of robot training is warranted.
Trial registration
ClinicalTrials.gov NCT01668407
doi:10.1186/1471-2377-13-50
PMCID: PMC3665527  PMID: 23706025
Parkinson’s disease; Gait analysis; Lower limb; Robot
3.  The ReSPonD trial - rivastigmine to stabilise gait in Parkinson’s disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson’s disease who have fallen 
BMC Neurology  2013;13:188.
Background
Gait impairment is common in people with Parkinson’s disease. There is a lack of effective interventions to target this debilitating complication and therefore a need to identify new therapeutic options. An underlying cholinergic deficit contributes to both the gait and cognitive dysfunction seen in Parkinson’s disease. The combined impact of both impairments can be assessed in gait tasks performed with concomitant cognitive tasks. The aim of this trial is to evaluate the impact of a cholinesterase inhibitor on cognitive function and gait performance in people with established Parkinson’s disease.
Methods/design
This is a single centre, double-blind, randomised placebo-controlled trial in 130 people with Hoehn and Yahr stage 2–3 idiopathic Parkinson’s disease who have fallen in the past year. Participants will be randomised to two groups, receiving either rivastigmine capsules or identical placebo capsules for 8 months. Assessment will be undertaken at baseline and at the end of medication prescription (i.e. 8 months) with participants remaining enrolled in the trial for a further 4 months to monitor for falls and adverse events. The primary outcome is step time variability, assessed with and without the addition of concurrent cognitive tasks. Secondary outcomes will include other gait parameters, sensorimotor and balance performances, cognitive indices, falls and fall related injury, fear of falling, Parkinson’s symptoms and data pertaining to possible harms.
Discussion
This randomised controlled trial will examine the effect of cholinesterase inhibitor therapy on gait, balance and falls in Parkinson’s disease. If effective, it would offer a new therapeutic option to ameliorating gait and cognitive deficits in a population at high risk of falls.
Trial registration
ISRCTN19880883, UTN U1111-1124-0244.
doi:10.1186/1471-2377-13-188
PMCID: PMC3880104  PMID: 24299497
Randomised control trial; Parkinson’s disease; Accidental Falls; Freezing of gait; Intervention; Gait analysis; Acetylcholinesterase; Cognitive; Attention; Dual-tasking
4.  Exercise therapy for prevention of falls in people with Parkinson's disease: A protocol for a randomised controlled trial and economic evaluation 
BMC Neurology  2009;9:4.
Background
People with Parkinson's disease are twice as likely to be recurrent fallers compared to other older people. As these falls have devastating consequences, there is an urgent need to identify and test innovative interventions with the potential to reduce falls in people with Parkinson's disease. The main objective of this randomised controlled trial is to determine whether fall rates can be reduced in people with Parkinson's disease using exercise targeting three potentially remediable risk factors for falls (reduced balance, reduced leg muscle strength and freezing of gait). In addition we will establish the cost effectiveness of the exercise program from the health provider's perspective.
Methods/Design
230 community-dwelling participants with idiopathic Parkinson's disease will be recruited. Eligible participants will also have a history of falls or be identified as being at risk of falls on assessment. Participants will be randomly allocated to a usual-care control group or an intervention group which will undertake weight-bearing balance and strengthening exercises and use cueing strategies to address freezing of gait. The intervention group will choose between the home-based or support group-based mode of the program. Participants in both groups will receive standardized falls prevention advice. The primary outcome measure will be fall rates. Participants will record falls and medical interventions in a diary for the duration of the 6-month intervention period. Secondary measures include the Parkinson's Disease Falls Risk Score, maximal leg muscle strength, standing balance, the Short Physical Performance Battery, freezing of gait, health and well being, habitual physical activity and positive and negative affect schedule.
Discussion
No adequately powered studies have investigated exercise interventions aimed at reducing falls in people with Parkinson's disease. This trial will determine the effectiveness of the exercise intervention in reducing falls and its cost effectiveness. This pragmatic program, if found to be effective, has the potential to be implemented within existing community services.
Trial registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000303347).
doi:10.1186/1471-2377-9-4
PMCID: PMC2637228  PMID: 19161631
5.  Cueing training in the home improves gait‐related mobility in Parkinson's disease: the RESCUE trial 
Objectives
Gait and mobility problems are difficult to treat in people with Parkinson's disease. The Rehabilitation in Parkinson's Disease: Strategies for Cueing (RESCUE) trial investigated the effects of a home physiotherapy programme based on rhythmical cueing on gait and gait‐related activity.
Methods
A single‐blind randomised crossover trial was set up, including 153 patients with Parkinson's disease aged between 41 and 80 years and in Hoehn and Yahr stage II–IV. Subjects allocated to early intervention (n = 76) received a 3‐week home cueing programme using a prototype cueing device, followed by 3 weeks without training. Patients allocated to late intervention (n = 77) underwent the same intervention and control period in reverse order. After the initial 6 weeks, both groups had a 6‐week follow‐up without training. Posture and gait scores (PG scores) measured at 3, 6 and 12 weeks by blinded testers were the primary outcome measure. Secondary outcomes included specific measures on gait, freezing and balance, functional activities, quality of life and carer strain.
Results
Small but significant improvements were found after intervention of 4.2% on the PG scores (p = 0.005). Severity of freezing was reduced by 5.5% in freezers only (p = 0.007). Gait speed (p = 0.005), step length (p<0.001) and timed balance tests (p = 0.003) improved in the full cohort. Other than a greater confidence to carry out functional activities (Falls Efficacy Scale, p = 0.04), no carry‐over effects were observed in functional and quality of life domains. Effects of intervention had reduced considerably at 6‐week follow‐up.
Conclusions
Cueing training in the home has specific effects on gait, freezing and balance. The decline in effectiveness of intervention effects underscores the need for permanent cueing devices and follow‐up treatment. Cueing training may be a useful therapeutic adjunct to the overall management of gait disturbance in Parkinson's disease.
doi:10.1136/jnnp.200X.097923
PMCID: PMC2077658  PMID: 17229744
6.  Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial 
BMC Neurology  2011;11:93.
Background
Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group).
Methods/Design
People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy.
Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes.
Discussion
This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594
doi:10.1186/1471-2377-11-93
PMCID: PMC3160881  PMID: 21801451
7.  Protocol for a home-based integrated physical therapy program to reduce falls and improve mobility in people with Parkinson’s disease 
BMC Neurology  2012;12:54.
Background
The high incidence of falls associated with Parkinson’s disease (PD) increases the risk of injuries and immobility and compromises quality of life. Although falls education and strengthening programs have shown some benefit in healthy older people, the ability of physical therapy interventions in home settings to reduce falls and improve mobility in people with Parkinson’s has not been convincingly demonstrated.
Methods/design
180 community living people with PD will be randomly allocated to receive either a home-based integrated rehabilitation program (progressive resistance strength training, movement strategy training and falls education) or a home-based life skills program (control intervention). Both programs comprise one hour of treatment and one hour of structured homework per week over six weeks of home therapy. Blinded assessments occurring before therapy commences, the week after completion of therapy and 12 months following intervention will establish both the immediate and long-term benefits of home-based rehabilitation. The number of falls, number of repeat falls, falls rate and time to first fall will be the primary measures used to quantify outcome. The economic costs associated with injurious falls, and the costs of running the integrated rehabilitation program from a health system perspective will be established. The effects of intervention on motor and global disability and on quality of life will also be examined.
Discussion
This study will provide new evidence on the outcomes and cost effectiveness of home-based movement rehabilitation programs for people living with PD.
Trial registration
The trial is registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12608000390381).
doi:10.1186/1471-2377-12-54
PMCID: PMC3436761  PMID: 22799601
Parkinson’s disease; Accidental falls; Randomized controlled trial; Falls prevention
8.  Tai Chi and Postural Stability in Patients with Parkinson's Disease 
The New England Journal of Medicine  2012;366(6):511-519.
Background
Patients with Parkinson's disease have substantially impaired balance, leading to diminished functional ability and an increased risk of falling. Although exercise is routinely encouraged by health care providers, few programs have been proven effective.
Methods
We conducted a randomized, controlled trial to determine whether a tailored tai chi program could improve postural control in patients with idiopathic Parkinson's disease. We randomly assigned 195 patients with stage 1 to 4 disease on the Hoehn and Yahr staging scale (which ranges from 1 to 5, with higher stages indicating more severe disease) to one of three groups: tai chi, resistance training, or stretching. The patients participated in 60-minute exercise sessions twice weekly for 24 weeks. The primary outcomes were changes from baseline in the limits-of-stability test (maximum excursion and directional control; range, 0 to 100%). Secondary outcomes included measures of gait and strength, scores on functional-reach and timed up-and-go tests, motor scores on the Unified Parkinson's Disease Rating Scale, and number of falls.
Results
The tai chi group performed consistently better than the resistance-training and stretching groups in maximum excursion (between-group difference in the change from baseline, 5.55 percentage points; 95% confidence interval [CI], 1.12 to 9.97; and 11.98 percentage points; 95% CI, 7.21 to 16.74, respectively) and in directional control (10.45 percentage points; 95% CI, 3.89 to 17.00; and 11.38 percentage points; 95% CI, 5.50 to 17.27, respectively). The tai chi group also performed better than the stretching group in all secondary outcomes and outperformed the resistance-training group in stride length and functional reach. Tai chi lowered the incidence of falls as compared with stretching but not as compared with resistance training. The effects of tai chi training were maintained at 3 months after the intervention. No serious adverse events were observed.
Conclusions
Tai chi training appears to reduce balance impairments in patients with mild-to-moderate Parkinson's disease, with additional benefits of improved functional capacity and reduced falls. (Funded by the National Institute of Neurological Disorders and Stroke; ClinicalTrials.gov number, NCT00611481.)
doi:10.1056/NEJMoa1107911
PMCID: PMC3285459  PMID: 22316445
9.  A comparison of specialist rehabilitation and care assistant support with specialist rehabilitation alone and usual care for people with Parkinson's living in the community: study protocol for a randomised controlled trial 
Trials  2011;12:250.
Background
Parkinson's Disease is a degenerative neurological condition that causes movement problems and other distressing symptoms. People with Parkinson's disease gradually lose their independence and strain is placed on family members. A multidisciplinary approach to rehabilitation for people with Parkinson's is recommended but has not been widely researched. Studies are needed that investigate cost-effective community-based service delivery models to reduce disability and dependency and admission to long term care, and improve quality of life.
Methods
A pragmatic three parallel group randomised controlled trial involving people with Parkinson's Disease and live-in carers (family friends or paid carers), and comparing: management by a specialist multidisciplinary team for six weeks, according to a care plan agreed between the professionals and the patient and carer (Group A); multidisciplinary team management and additional support for four months from a trained care assistant (Group B); usual care, no coordinated team care planning or ongoing support (Group C). Follow up will be for six months to determine the impact and relative cost-effectiveness of the two interventions, compared to usual care. The primary outcomes are disability (patients) and strain (carers). Secondary outcomes include patient mobility, falls, speech, pain, self efficacy, health and social care use; carer general health; patient and carer social functioning, psychological wellbeing, health related quality of life. Semi structured interviews will be undertaken with providers (team members, care assistants), service commissioners, and patients and carers in groups A and B, to gain feedback about the acceptability of the interventions. A cost - effectiveness evaluation is embedded in the trial.
Discussion
The trial investigates components of recent national policy recommendations for people with long term conditions, and Parkinson's Disease in particular, and will provide guidance to inform local service planning and commissioning.
Trial registration
ISRCTN: ISRCTN44577970
doi:10.1186/1745-6215-12-250
PMCID: PMC3261836  PMID: 22112960
Parkinson's disease; Multidisciplinary rehabilitation; Domiciliary; Randomised controlled trial
10.  Exercise therapy, quality of life, and activities of daily living in patients with Parkinson disease: a small scale quasi-randomised trial 
Trials  2009;10:67.
Background
The purpose of this study was to examine the effect of a 10-week exercise therapy regimen on activities of daily living (ADL) and perceived health status in patients with Parkinson disease.
Methods
Twenty-four Parkinson's disease patients entered into the study. Participants were allocated into the experimental (n = 12) or control group (n = 12). ADL was assessed using the Short Parkinson Evaluation Scale/Scale for Outcomes in Parkinson Disease (SPES/SCOPA) and perceived health status was measured using the Parkinson's Disease Quality of Life (PDQL) questionnaire. Patients in the experimental group received pharmacological therapy plus a 1-hour exercise therapy session 4 times a week, while patients in the control group received pharmacological therapy only. The Mann-Whitney U test was used for comparison.
Results
The mean age of participants was 59.8 (SD = 3.0) and 58.2 (SD = 3.4) years in the experimental and control groups, respectively. The median Hoehn and Yahr stage was 3.0 for both groups. There were no significant differences in all subscales and overall scores between two groups at baseline. However, after the intervention, except for the emotional functioning (P = 0.27), there were significant differences between the two groups for Parkinson symptoms, systemic symptoms, social functioning, and overall scores of the PDQL (all P values < 0.05), and the ADL (P = 0.01) indicating that quality of life was improved in the experimental group.
Conclusion
The findings from this small scale quasi-randomised trial showed that exercise therapy was effective in improving activities of daily living and perceived health status in patients with Parkinson's disease. Indeed, exercise therapy could be offered to patients with Parkinson disease, considering that it is low in cost and usually has no negative side effects.
Trial registration
Current Controlled Trials ISRCTN98825027
doi:10.1186/1745-6215-10-67
PMCID: PMC2736167  PMID: 19671145
11.  The gait and balance of patients with diabetes can be improved: a randomised controlled trial 
Diabetologia  2009;53(3):458-466.
Aims/hypothesis
Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients.
Methods
This was a randomised controlled trial (n = 71) with an intervention (n = 35) and control group (n = 36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (twice weekly over 12 weeks). Controls received no treatment. Individuals were allocated to the groups in a central office. Gait, balance, fear of falls, muscle strength and joint mobility were measured at baseline, after intervention and at 6-month follow-up.
Results
The trial is closed to recruitment and follow-up. After training, the intervention group increased habitual walking speed by 0.149 m/s (p < 0.001) compared with the control group. Patients in the intervention group also significantly improved their balance (time to walk over a beam, balance index recorded on Biodex balance system), their performance-oriented mobility, their degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility compared with the control group. After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength. Two patients developed pain in their Achilles tendon: the progression for two related exercises was slowed down.
Conclusions/interpretation
Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patients. Further studies are needed to explore the influence of these improvements on the number of reported falls, patients’ physical activity levels and quality of life.
Trial registration:
ClinicalTrials.gov NCT00637546
Funding:
This work was supported by the Swiss National Foundation (SNF): PBSKP-123446/1/
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-009-1592-4) contains supplementary material, which is available to authorised users.
doi:10.1007/s00125-009-1592-4
PMCID: PMC2815802  PMID: 19921145
Balance; Clinical diabetes; Diabetic foot; Exercise; Fear; Gait disorders; Joint mobility; Neuropathy; Muscle strength; Walking
12.  Short Duration, Intensive Tango Dancing for Parkinson Disease: An Uncontrolled Pilot Study 
Objective
The goal of this pilot study was to determine the effects of short duration, intensive tango lessons on functional mobility in people with Parkinson disease.
Design
This study employed a within-subject, prospective, repeated measures design.
Subjects/Patients
Fourteen people with idiopathic Parkinson disease participated.
Setting
All balance and gait assessments were performed in a laboratory, but dance classes took place in a large, open classroom.
Interventions
Participants completed ten 1.5 hour long Argentine tango dance lessons within two weeks. Their balance, gait and mobility were assessed before and after the training sessions.
Main Outcome Measures
Measures included the Berg Balance Scale, the Unified Parkinson Disease Rating Scale, gait velocity, functional ambulation profile, step length, stance and single support percent of gait, Timed Up and Go, and the six minute walk.
Results
Participants significantly improved on the Berg Balance Scale (effect size (ES) = 0.83, p = 0.021), Unified Parkinson Disease Rating Scale Motor Subscale III (ES = −0.64, p = 0.029), and percent of time spent in stance during forward walking (ES = 0.97, p = 0.015). Non-significant improvements were noted on the Timed Up and Go (ES = −0.38, p = 0.220) and 6-minute walk (ES = 0.35, p = 0.170).
Conclusions
Frequent social dance lessons completed within a short time period appear to be appropriate and effective for these individuals with mild-moderately severe Parkinson disease.
doi:10.1016/j.ctim.2008.10.005
PMCID: PMC2731655  PMID: 19632547
rehabilitation; Parkinson disease; gait; balance; dance
13.  Effects of a Flexibility and Relaxation Programme, Walking, and Nordic Walking on Parkinson's Disease 
Journal of Aging Research  2011;2011:232473.
Symptoms of Parkinson's disease (PD) progress despite optimized medical treatment. The present study investigated the effects of a flexibility and relaxation programme, walking, and Nordic walking (NW) on walking speed, stride length, stride length variability, Parkinson-specific disability (UPDRS), and health-related quality of life (PDQ 39). 90 PD patients were randomly allocated to the 3 treatment groups. Patients participated in a 6-month study with 3 exercise sessions per week, each lasting 70 min. Assessment after completion of the training showed that pain was reduced in all groups, and balance and health-related quality of life were improved. Furthermore, walking, and Nordic walking improved stride length, gait variability, maximal walking speed, exercise capacity at submaximal level, and PD disease-specific disability on the UPDRS in addition. Nordic walking was superior to the flexibility and relaxation programme and walking in improving postural stability, stride length, gait pattern and gait variability. No significant injuries occurred during the training. All patients of the Nordic walking group continued Nordic walking after completing the study.
doi:10.4061/2011/232473
PMCID: PMC3095265  PMID: 21603199
14.  Comparisons of therapeutic effects of levodopa, levodopa and selegiline, and bromocriptine in patients with early, mild Parkinson's disease: three year interim report. Parkinson's Disease Research Group in the United Kingdom. 
BMJ : British Medical Journal  1993;307(6902):469-472.
OBJECTIVE--To determine the optimum treatment for early Parkinson's disease. DESIGN--An open, long term, prospective randomised trial conducted by the Parkinson's Disease Research Group of the United Kingdom. SETTING--93 hospitals throughout the United Kingdom. SUBJECTS--782 patients with early Parkinson's disease who were not receiving dopaminergic treatment. INTERVENTIONS--Patients allocated to treatment with levodopa/dopa decarboxylase inhibitor alone (arm 1), levodopa/decarboxylase inhibitor/selegiline in combination (arm 2), or bromocriptine (arm 3). MAIN OUTCOME MEASURES--Disability assessment as judged by improvement on Hoehn and Yahr, modified Webster, and North Western University disability scales. Adverse event profile and mortality ratios. RESULTS--Interim results indicate that all three treatment regimens led to improvement in baseline disabilities after 12 months' treatment and that deterioration in control was apparent by three years. No significant differences were found between the results of treatment in arm 1 and arm 2, but both were significantly more effective than bromocriptine (arm 3) and had fewer early adverse reactions. The adjusted difference (95% confidence interval) in Webster rating for arm 3 v 1 was 0.93 points (0.27 to 1.50; p = 0.0058) and for arm 3 v 2 was 1.25 points (0.61 to 1.89; p = 0.0002). The incidence of dyskinesias and motor oscillations, however, was significantly lower in arm 3 (2% and 5%, respectively) than in arm 1 (27% and 33%, respectively) and arm 2 (34% and 35%, respectively). CONCLUSIONS--As there were no marked differences in functional improvement between the three groups the choice of treatment in the early stages of Parkinson's disease may not be critical.
PMCID: PMC1678739  PMID: 8400928
15.  Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson’s disease: the DUALITY trial 
BMC Neurology  2014;14:61.
Background
Multiple tasking is an integral part of daily mobility. Patients with Parkinson’s disease have dual tasking difficulties due to their combined motor and cognitive deficits. Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties: either to discourage simultaneous execution of dual tasks (consecutive training); or to practice their concurrent use (integrated training). It is currently unclear which of these training methods should be adopted to achieve safe and consolidated dual task performance in daily life. Therefore, the proposed randomized controlled trial will compare the effects of integrated versus consecutive training of dual tasking (tested by combining walking with cognitive exercises).
Methods and design
Hundred and twenty patients with Parkinson’s disease will be recruited to participate in this multi-centered, single blind, randomized controlled trial. Patients in Hoehn & Yahr stage II-III, with or without freezing of gait, and who report dual task difficulties will be included. All patients will undergo a six-week control period without intervention after which they will be randomized to integrated or consecutive task practice. Training will consist of standardized walking and cognitive exercises delivered at home four times a week during six weeks. Treatment is guided by a physiotherapist twice a week and consists of two sessions of self-practice using an MP3 player. Blinded testers will assess patients before and after the control period, after the intervention period and after a 12-week follow-up period. The primary outcome measure is dual task gait velocity, i.e. walking combined with a novel untrained cognitive task to evaluate the consolidation of learning. Secondary outcomes include several single and dual task gait and cognitive measures, functional outcomes and a quality of life scale. Falling will be recorded as a possible adverse event using a weekly phone call for the entire study period.
Discussion
This randomized study will evaluate the effectiveness and safety of integrated versus consecutive task training in patients with Parkinson’s disease. The study will also highlight whether dual task gait training leads to robust motor learning effects, and whether these can be retained and carried-over to untrained dual tasks and functional mobility.
Trial registration
Clinicaltrials.gov NCT01375413.
doi:10.1186/1471-2377-14-61
PMCID: PMC3974198  PMID: 24674594
Parkinson disease; Rehabilitation; Physical therapy; Neurologic gait disorder; Cognition; Dual task
16.  Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial 
Trials  2013;14:34.
Background
Occupational therapists may have an added value in the care of patients with Parkinson’s disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson’s disease.
Methods/Design
A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson’s disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation.
Discussion
This is the first large-scale trial specifically evaluating occupational therapy in Parkinson’s disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson’s disease.
Trial registration
Clinicaltrials.gov: NCT01336127.
doi:10.1186/1745-6215-14-34
PMCID: PMC3599260  PMID: 23374761
Parkinson disease; Occupational therapy; Guidelines; caregiver; Randomized controlled trial; Study protocol; Effectiveness; Economic evaluation
17.  Promotion of physical activity and fitness in sedentary patients with Parkinson’s disease: randomised controlled trial 
Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson’s disease.
Design Multicentre randomised controlled trial.
Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet).
Participants 586 sedentary patients with idiopathic Parkinson’s disease aged between 40 and 75 years with mild to moderate disease severity (Hoehn and Yahr stage ≤3).
Intervention Patients were randomly assigned to the ParkFit programme or a matched general physiotherapy intervention. ParkFit is a multifaceted behavioural change programme, designed specifically to achieve an enduring increase in the level of physical activity (coaches using motivational strategies; ambulatory feedback).
Main outcome measures The primary endpoint was the level of physical activity, measured every six months with a standardised seven day recall (LASA physical activity questionnaire—LAPAQ). Secondary endpoints included two other measures of physical activity (activity diary and ambulatory activity monitor), quality of life (Parkinson’s disease questionnaire—PDQ-39), and fitness (six minute walk test).
Results 540 (92.2%) patients completed the primary outcome. During follow-up, overall time spent on physical activities (LAPAQ) was comparable between the groups (adjusted group difference 7%, 95% confidence interval −3 to 17%; P=0.19). Analyses of three secondary outcomes indicated increased physical activity in ParkFit patients, as suggested by the activity diary (difference 30%; P<0.001), the activity monitor (difference 12%; P<0.001), and the six minute walk test (difference 4.8 m; P=0.05). PDQ-39 did not differ between ParkFit patients and controls (difference −0.9 points; P=0.14). The number of fallers was comparable between ParkFit patients (184/299; 62%) and controls (191/287; 67%).
Conclusions The ParkFit behavioural change programme did not increase overall physical activity, as measured with the LAPAQ. The analysis of the secondary endpoints justifies further work into the possible merits of behavioural change programmes to increase physical activities in daily life in Parkinson’s disease.
Trial registration Clinical trials NCT00748488.
doi:10.1136/bmj.f576
PMCID: PMC3585777  PMID: 23457213
18.  Tai Chi Improves Balance and Mobility in People with Parkinson Disease 
Gait & posture  2008;28(3):456-460.
This pilot study examines the effects of Tai Chi on balance, gait and mobility in people with Parkinson disease (PD). Thirty-three people with PD were randomly assigned to either a Tai Chi group or a control group. The Tai Chi group participated in 20 one-hour long training sessions completed within 10–13 weeks; whereas, the control group had two testing sessions between 10 and 13 weeks apart without interposed training. The Tai Chi group improved more than the control group on the Berg Balance Scale, UPDRS, Timed Up and Go, tandem stance test, 6-minute walk, and backward walking. Neither group improved in forward walking or the one leg stance test. All Tai Chi participants reported satisfaction with the program and improvements in well-being. Tai Chi appears to be an appropriate, safe and effective form of exercise for some individuals with mild-moderately severe PD.
doi:10.1016/j.gaitpost.2008.02.005
PMCID: PMC2552999  PMID: 18378456
19.  Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial 
Lancet Neurology  2010;9(6):581-591.
Summary
Background
Surgical intervention for advanced Parkinson's disease is an option if medical therapy fails to control symptoms adequately. We aimed to assess whether surgery and best medical therapy improved self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease.
Methods
The PD SURG trial is an ongoing randomised, open-label trial. At 13 neurosurgical centres in the UK, between November, 2000, and December, 2006, patients with Parkinson's disease that was not adequately controlled by medical therapy were randomly assigned by use of a computerised minimisation procedure to immediate surgery (lesioning or deep brain stimulation at the discretion of the local clinician) and best medical therapy or to best medical therapy alone. Patients were analysed in the treatment group to which they were randomised, irrespective of whether they received their allocated treatment. The primary endpoint was patient self-reported quality of life on the 39-item Parkinson's disease questionnaire (PDQ-39). Changes between baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222.
Findings
366 patients were randomly assigned to receive immediate surgery and best medical therapy (183) or best medical therapy alone (183). All patients who had surgery had deep brain stimulation. At 1 year, the mean improvement in PDQ-39 summary index score compared with baseline was 5·0 points in the surgery group and 0·3 points in the medical therapy group (difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean change in PDQ-39 score in the mobility domain between the surgery group and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0; p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to −7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6 to −2·4; p=0·004). Differences between groups in all other domains of the PDQ-39 were not significant. 36 (19%) patients had serious surgery-related adverse events; there were no suicides but there was one procedure-related death. 20 patients in the surgery group and 13 in the best medical therapy group had serious adverse events related to Parkinson's disease and drug treatment.
Interpretation
At 1 year, surgery and best medical therapy improved patient self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease. These differences are clinically meaningful, but surgery is not without risk and targeting of patients most likely to benefit might be warranted.
Funding
UK Medical Research Council, Parkinson's UK, and UK Department of Health.
doi:10.1016/S1474-4422(10)70093-4
PMCID: PMC2874872  PMID: 20434403
20.  Tai Chi Exercise to Improve Non-Motor Symptoms of Parkinson’s Disease 
Journal of yoga & physical therapy  2013;3:10.4172/2157-7595.1000137.
Background
A substantial number of individuals with Parkinson’s disease exhibit debilitating non-motor symptoms that decrease quality of life. To date, few treatment options exist for the non-motor symptomatology related to Parkinson’s disease. The goal of this pilot investigation was to determine the effects of Tai Chi exercise on the non-motor symptomology in Parkinson’s disease.
Methods
Twenty-one individuals with Parkinson’s disease were enrolled in a Tai Chi intervention (n=15) or a noncontact control group (n=6). Participants assigned to Tai Chi participated in 60-minute Tai Chi sessions three times per week, for 16 weeks.
Pre and post measures included indices of cognitive-executive function including visuomotor tracking and attention, selective attention, working memory, inhibition, processing speed and task switching. Additionally, all participants were evaluated on the Parkinson’s disease Questionnaire-39 and Tinetti’s Falls Efficacy Scale.
Results
Results indicated that the Tai Chi training group had significantly better scores following the intervention than the control group on the Parkinson’s disease Questionnaire-39 total score as well as the emotional well-being sub score. Trends for improvement were noted for the Tai Chi group on Digits Backwards, Tinetti’s Falls Efficacy Scale, and the activities of daily living and communication sub scores of the Parkinson’s disease Questionnaire-39.
Conclusions
This research provides initial data that supports future studies to definitively establish efficacy of Tai Chi to improve non-motor features of Parkinson’s disease.
doi:10.4172/2157-7595.1000137
PMCID: PMC3837454  PMID: 24278789
Neurodegenerative disease; Exercise; Cognition
21.  Neuroprotective effects and mechanisms of exercise in a chronic mouse model of Parkinson’s disease with moderate neurodegeneration 
The European journal of neuroscience  2011;33(7):1264-1274.
The protective impact of exercise on neurodegenerative processes has not been confirmed, and the mechanisms underlying the benefit of exercise have not been determined in human Parkinson’s disease or in chronic animal disease models. This research examined the long-term neurological, behavioral, and mechanistic consequences of endurance exercise in experimental chronic parkinsonism. We used a chronic 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced mouse model of Parkinson’s disease with moderate neurodegeneration and examined the effects of treadmill exercise on movement and balance coordination, changes in dopamine neuron biomarkers, mitochondrial functions, and neurotrophic factor activities in the nigrostriatal system. The exercise results were compared with that of the control and sedentary chronic parkinsonian animals. After 18 weeks of exercise training in the chronic parkinsonian mice, we observed a significant deterrence in the loss of neuronal dopamine-producing cells and other functional indicators. The impaired movement and balance incoordination in the chronic parkinsonian mice were also markedly reduced following exercise. Mechanistic investigations revealed that the neuronal and behavioral recovery produced by exercise in the chronic parkinsonian mice was associated with an improved mitochondrial function and an increase in the brain region-specific levels of brain-derived and glial cell line-derived neurotrophic factors. Our findings indicate that exercise not only produces neuronal and mitochondrial protection, it also boosts nigrostriatal neurotrophic factor levels in the chronic parkinsonian mice with moderate neurodegeneration. Therefore, modifying lifestyle with increased exercise activity would be a non-pharmacological neuroprotective approach for averting neurodegenerative processes, as demonstrated in experimental chronic parkinsonism.
doi:10.1111/j.1460-9568.2011.07626.x
PMCID: PMC3079264  PMID: 21375602
MPTP parkinsonism; endurance exercise; neuroprotection; mitochondrial dysfunction; neurotrophic factor
22.  Physiotherapy intervention in Parkinson’s disease: systematic review and meta-analysis  
Objective To assess the effectiveness of physiotherapy compared with no intervention in patients with Parkinson’s disease.
Design Systematic review and meta-analysis of randomised controlled trials.
Data sources Literature databases, trial registries, journals, abstract books, and conference proceedings, and reference lists, searched up to the end of January 2012.
Review methods Randomised controlled trials comparing physiotherapy with no intervention in patients with Parkinson’s disease were eligible. Two authors independently abstracted data from each trial. Standard meta-analysis methods were used to assess the effectiveness of physiotherapy compared with no intervention. Tests for heterogeneity were used to assess for differences in treatment effect across different physiotherapy interventions used. Outcome measures were gait, functional mobility and balance, falls, clinician rated impairment and disability measures, patient rated quality of life, adverse events, compliance, and economic analysis outcomes.
Results 39 trials of 1827 participants met the inclusion criteria, of which 29 trials provided data for the meta-analyses. Significant benefit from physiotherapy was reported for nine of 18 outcomes assessed. Outcomes which may be clinically significant were speed (0.04 m/s, 95% confidence interval 0.02 to 0.06, P<0.001), Berg balance scale (3.71 points, 2.30 to 5.11, P<0.001), and scores on the unified Parkinson’s disease rating scale (total score −6.15 points, −8.57 to −3.73, P<0.001; activities of daily living subscore −1.36, −2.41 to −0.30, P=0.01; motor subscore −5.01, −6.30 to −3.72, P<0.001). Indirect comparisons of the different physiotherapy interventions found no evidence that the treatment effect differed across the interventions for any outcomes assessed, apart from motor subscores on the unified Parkinson’s disease rating scale (in which one trial was found to be the cause of the heterogeneity).
Conclusions Physiotherapy has short term benefits in Parkinson’s disease. A wide range of physiotherapy techniques are currently used to treat Parkinson’s disease, with little difference in treatment effects. Large, well designed, randomised controlled trials with improved methodology and reporting are needed to assess the efficacy and cost effectiveness of physiotherapy for treating Parkinson’s disease in the longer term.
doi:10.1136/bmj.e5004
PMCID: PMC3412755  PMID: 22867913
23.  A comparison of Irish set dancing and exercises for people with Parkinson’s disease: A phase II feasibility study 
BMC Geriatrics  2013;13:54.
Background
People with idiopathic Parkinson’s disease (PD) frequently have low activity levels, poor mobility and reduced quality of life. Although increased physical activity may improve mobility, balance and wellbeing, adherence to exercises and activity programs over the longer term can be challenging, particularly for older people with progressive neurological conditions such as PD. Physical activities that are engaging and enjoyable, such as dancing, might enhance adherence over the long term. The objective of this study was to evaluate the feasibility of a randomized controlled trial of Irish set dancing compared with routine physiotherapy for people with mild to moderately severe PD.
Methods
Twenty-four people with idiopathic PD referred for movement rehabilitation were randomized to receive standard physiotherapy exercises or Irish set dancing classes once per week plus a weekly home program for 6 months (12 in each group). The feasibility and safety of the proposed RCT protocol was the main focus of this evaluation. The primary outcome was motor disability measured by the motor component of the UPDRS, which was assessed prior to and after therapy by trained assessors blinded to group assignment. The Timed Up and Go, the Berg Balance Scale and the modified Freezing of Gait Questionnaire were secondary measures. Quality of life of the people with PD was evaluated using the PDQ-39.
Results
Both the Irish set dancing and physiotherapy exercise program were shown to be feasible and safe. There were no differences between groups in the rate of adverse events such as falls, serious injuries, death or rates of admission to hospital. The physiotherapists who provided usual care remained blind to group allocation, with no change in their standard clinical practice. Compliance and adherence to both the exercise and dance programs were very high and attrition rates were low over the 6 months of therapy. Although improvements were made in both groups, the dance group showed superior results to standard physiotherapy in relation to freezing of gait, balance and motor disability.
Conclusions
Irish dancing and physiotherapy were both safe and feasible in this sample from Venice, with good adherence over a comparatively long time period of 6 months. A larger multi-centre trial is now warranted to establish whether Irish set dancing is more effective than routine physiotherapy for enhancing mobility, balance and quality of life in people living with idiopathic PD.
Trial registration
EudraCT number 2012-005769-11
doi:10.1186/1471-2318-13-54
PMCID: PMC3685562  PMID: 23731986
Parkinson’s disease; Dancing; Rehabilitation; Exercise therapy; Balance; Randomized controlled trial; Geriatrics
24.  Effects of Dance on Movement Control in Parkinson’s Disease: A Comparison of Argentine Tango and American Ballroom 
Objective
The basal ganglia may be selectively activated during rhythmic, metered movement like tango dancing, which may improve motor control in individuals with Parkinson disease (PD). Other partner dances may be suitable and preferable for those with PD. The purpose of this study was to compare the effects of tango, waltz/foxtrot and no intervention on functional motor control in individuals with PD.
Design
This study employed a randomised, between-subject, prospective, repeated measures design.
Subjects/Patients
Fifty-eight people with mild-moderate PD participated.
Methods
Participants were randomly assigned to Tango, Waltz/Foxtrot or no intervention (Control). Those in the dance groups attended 1-hour classes 2 times per week, completing 20 lessons within thirteen weeks. Balance, functional mobility, forward and backward walking were evaluated before and after the intervention.
Results
Both dance groups improved more than the Control group, which did not improve. Tango and Waltz/Foxtrot significantly improved on the Berg Balance Scale, six minute walk distance, and backward stride length. Tango improved as much or more than those in Waltz/Foxtrot on several measures.
Conclusions
Tango may target deficits associated with PD more than Waltz/Foxtrot, but both dances may benefit balance and locomotion.
doi:10.2340/16501977-0362
PMCID: PMC2688709  PMID: 19479161
dance; Parkinson’s Disease; balance; gait; freezing of gait
25.  A waitlist-controlled trial of group cognitive behavioural therapy for depression and anxiety in Parkinson’s disease 
BMC Psychiatry  2014;14:19.
Background
The aim of this study was to evaluate the efficacy of a group Cognitive Behavioural Therapy (CBT) treatment for depression and anxiety in Parkinson’s disease (PD).
Methods
A waitlist-controlled trial design was used. Eighteen adults with PD and a comorbid DSM-IV-TR diagnosis of depression and/or anxiety were randomised to either Intervention (8-week group CBT treatment) or Waitlist (8-week clinical monitoring preceding treatment). The Depression, Anxiety, Stress Scale-21 (DASS-21) was the primary outcome. Assessments were completed at Time 1 (pretreatment), Time 2 (posttreatment/post-waitlist) and 1-month and 6-month follow-ups.
Results
At Time 2, participants who received CBT reported greater reductions in depression (Mchange = -2.45) than Waitlist participants (Mchange = .29) and this effect was large, d = 1.12, p = .011. Large secondary effects on anxiety were also observed for CBT participants, d = .89, p = .025. All treatment gains were maintained and continued to improve during the follow-up period. At 6-month follow-up, significant and large effects were observed for both depression (d = 2.07) and anxiety (d = 2.26).
Conclusions
Group CBT appears to be an efficacious treatment approach for depression and anxiety in PD however further controlled trials with larger numbers of participants are required.
Trial registration
Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12610000455066)
doi:10.1186/1471-244X-14-19
PMCID: PMC3907935  PMID: 24467781
Depression; Anxiety; Parkinson’s disease; Cognitive behavioural therapy; Psychotherapy; Treatment; Randomised controlled trial

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