Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial

Renan L Monteiro, Jane S S P Ferreira, Érica Q Silva, Asha Donini, Ronaldo H Cruvinel-Júnior, Jady L Verissímo, Sicco A Bus, Isabel C N Sacco, Renan L Monteiro, Jane S S P Ferreira, Érica Q Silva, Asha Donini, Ronaldo H Cruvinel-Júnior, Jady L Verissímo, Sicco A Bus, Isabel C N Sacco

Abstract

Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants' satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.

Keywords: clinical trial; diabetic foot; diabetic neuropathies; exercise; physical therapy; plantar pressure; range of motion.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of the feasibility study. DPN - Diabetic neuropathy.
Figure 2
Figure 2
Participant satisfaction with the exercise protocol (n = 15). Scores are shown on a 5-point Likert scale. Data are shown as mean, maximum and minimum. Statement number: (1) “I am satisfied with the exercise protocol”; (2) “The exercise protocol is easy to perform ”; (3) “The exercise protocol is fun to perform”; (4) “The exercise protocol met my expectations”; (5) “The exercise protocol somehow improved my walking practice”.

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