A multifaceted podiatry intervention was effective in reducing falls in community dwelling older people with disabling foot pain, suggesting that this approach may be a useful addition to existing falls prevention programmes. This randomised trial is the first to evaluate a falls prevention intervention specifically targeting foot and footwear risk factors. The observed 36% reduction in falls rate is similar to the reduction achieved with individually prescribed multiple component home based exercises, Tai Chi, and cataract surgery reported in the most recent Cochrane review of community based falls prevention trials.38
In addition to the reduced falling rate, fewer participants in the intervention group than control group had a fracture resulting from a fall during the trial, but this did not reach significance (P=0.07). This pattern is similar to that found in other fall prevention studies involving home based exercise39
and cataract surgery.40
It is likely that the lack of a significant reduction in fractures in this trial resulted from the relatively small number of fractures reported, with consequent low statistical power for this outcome measure.
The proportion of fallers or multiple fallers did not differ significantly between the groups, although the trend was for a greater proportion of fallers in the control group, particularly multiple fallers. Although it is not uncommon for trials on falls to report a reduction in the rate of falls but no significant difference in the proportion of fallers,41 42 43
this trial may have been underpowered for detecting a difference in the proportion of fallers, as our sample had a lower risk of falls than anticipated. The a priori sample size calculation used a falls rate of 60% in the control group based on a previous study of older people with foot pain, but during the trial only 49% of the control group fell.
Analysis of the secondary outcome measures suggests that the observed reduction in falls may in part be mediated by increases in foot and ankle strength and range of motion, leading to improvements in balance and functional ability. It has been shown previously that muscle strength at the ankle is correlated with balance,44 45
and functional movements.47 48 49
Although increases in muscle strength after exercise interventions with associated improvements in balance, functional ability, and reduction in falls have been well established,38 50 51
previous studies have concentrated on muscle groups proximal to the foot and ankle. While this is the first large randomised trial to focus specifically on the foot and ankle, it concurs with smaller trials that have reported improvements in foot and ankle strength after exercise programmes.49 52 53
The observed improvements in the intervention group in strength and range of motion, in conjunction with improvement in some balance measures, suggest that the intervention resulted in changes in the musculoskeletal system that reduces the risk of falling.
The multifaceted nature of the intervention makes it difficult to delineate the relative contribution of each component in preventing falls. However, it is likely that the exercise programme was the key component of the intervention, for two main reasons. Firstly, improvements occurred in the secondary outcomes of foot and ankle strength and range of motion, which are unlikely to have resulted from the footwear or foot orthoses components. Secondly, less than one third of the study population presented with inappropriate footwear, and only 17% (n=26) of the intervention group purchased new footwear, so the contribution of this component of the intervention would have been relatively minor. Although the foot orthoses used in the study were not specifically designed to improve balance, they may have had a direct effect on balance by improving foot stability and enhancing plantar sensory feedback54
and an indirect effect by reducing plantar pressure and foot pain, both of which have been identified as risk factors for falls.55
The relatively low need to provide new footwear was a surprising aspect of this trial, as previous studies have indicated that between 43% and 75% of older people wear inappropriate footwear.12 13 56
A likely explanation for the relatively low prevalence of inappropriate footwear is that most of the participants regularly accessed podiatry services, where appropriate footwear would have been frequently emphasised. However, it also needs to be acknowledged that we did not consider participants’ indoor footwear. It has previously been reported that selection of indoor footwear by older people is influenced primarily by comfort and low cost, and that household shoes are infrequently replaced.57
As such, it is possible that several participants wore suboptimal indoor footwear that may have contributed to their risk of falling.
Adherence to the intervention
Adherence to the intervention was generally good, with more than half of the participants performing 75% of the exercise sessions and wearing the foot orthoses on a regular basis. However, 29% of those identified as wearing inappropriate outdoor footwear did not take up the option of purchasing new shoes, despite receiving advice about the possible risks associated with their footwear and being provided with a voucher to partly cover the costs. Several previous studies have reported difficulties in convincing older people to change their footwear to improve their foot health or decrease their risk of falls,58 59 60
which has been attributed to the unique role of footwear as both an item of clothing and a health related intervention.61
Given the somewhat conflicting requirements of aesthetics and function, specifically in relation to women’s shoes, it is likely that full adherence to footwear interventions will continue to be difficult to achieve.
Despite the inherent difficulties in promoting adherence to footwear recommendations, the multifaceted intervention evaluated in this study could potentially be incorporated into routine podiatry practice or multidisciplinary falls prevention clinics. The home based exercise programme is feasible for older people to undertake, requires simple and inexpensive equipment, and can be easily explained to participants with the assistance of a booklet and accompanying DVD. Furthermore, the foot orthoses used are prefabricated, so do not require the time consuming and costly casting and manufacturing processes associated with individually customised devices. The cost effectiveness of the multifaceted intervention is yet to be undertaken, however, and would vary according to the clinical context in which it was to be administered.
Strengths and limitations of the study
The strengths of our study are its high completion rate and small losses to follow-up. However, the findings need to be interpreted in the context of certain limitations. Firstly, owing to the nature of the intervention, it was not possible to blind participants to their group allocation. Secondly, the sample may have been biased towards volunteers with a heightened interest and commitment in the intervention, as 195 people who initially expressed interest declined participation, primarily due to reluctance to commit to the study for a 12 month period. Thirdly, the intervention did not target all relevant risk factors for foot and ankle. Both hallux valgus and deformity of the lesser toes have been shown to increase the risk of falls,9 10
but these conditions generally require surgical treatment, which was beyond the scope of the study. Finally, care needs to be taken in generalising these findings, as all participants were living independently in the community, had disabling foot pain and an increased risk of falling, and regularly accessed podiatry services. Whether the intervention is effective in residential care settings or in older people without foot pain requires further investigation.
The findings of this study show that a multifaceted podiatry intervention is an effective falls prevention strategy in older people with disabling foot pain and an increased risk of falls. The reduction in falls is likely to be related to the significant improvements found in several measures of foot and ankle strength and range of motion, balance, and functional ability. The components of the intervention are inexpensive and relatively simple to implement, suggesting that the programme could be incorporated into routine podiatry practice or multidisciplinary falls prevention clinics.
What is already known on this topic
- Foot problems impair balance and gait and increase the risk of falls
- Inappropriate footwear impairs balance and increases the risk of falls
What this study adds
- A multifaceted podiatry intervention consisting of a foot and ankle exercise programme, foot orthoses, advice on footwear, subsidised footwear, and general falls education significantly reduced the rate of falls in community dwelling older people with disabling foot pain