Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial

Objective: To examine the effects of bilateral custom-made ankle-foot orthoses (AFOs) to prevent falls for older adults with concern about or at risk for falling over 12-month daily use.

Design: Secondary analysis of a randomized controlled trial.

Setting: Community-dwelling older adults.

Intervention: Half of the participants were randomly allocated to an intervention group (IG) that received fitted walking shoes and bilateral custom-made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes.

Measurements: Self-reported fall history of 12-month duration was investigated at baseline and 12-month follow-up for both groups. Fall incidence rate and proportion of fallers were used as outcome measures to determine effects of 12-month footwear intervention in either group.

Participants: Adults aged 65 years and older with concern about or at risk for falling (n = 44).

Results: No significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882). Within the IG, significant reductions were found in the fall incidence rate (P = .039) and the proportion of fallers (P = .036) at the 12-month follow-up compared to the baseline. Within the CG, no significant change was found at the 12-month follow-up compared to the baseline for the fall incidence rate (P = .217) or the proportion of fallers (P = .757). When comparing the IG with the CG, there was no significant difference in the change from the baseline to the 12-month follow-up for the fall incidence rate (P = .572) or the proportion of fallers (P = .080).

Conclusion: This study failed to demonstrate a significant benefit of bilateral custom-made AFOs to reduce falls compared to fitted walking shoes. However, the AFO users had significant reductions in falls compared to the preceding year. A future study with a larger sample size is recommended to confirm these observations. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02819011. J Am Geriatr Soc 67:1656-1661, 2019.