Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I

Abstract

Background: Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD).

Methods: Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group.

Results: In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants' median level of satisfaction was 5.0 (IQR: 4.5-5.0) and perceived safety was 5.0 (IQR: 5.0-5.0).

Conclusion: The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial.

Trial registration: ClinicalTrials.gov, NCT04011267 . Registered on 8 July 2019.

Keywords: Diabetic neuropathy; Feasibility study; Foot-related exercises; Musculoskeletal function; Preventive care; Rehabilitation technology; Self-management; eHealth.

Fig. 1

Flowchart of the feasibility study explaining reasons for inclusion and exclusion. T12—evaluation at 12 weeks, DM—diabetes mellitus, DPN—diabetic peripheral neuropathy, SOPeD—Diabetic Foot Guidance System

Fig. 2

Diabetic Foot Guidance System (SOPeD). a Perceived effort scale to be completed after each exercise performed. b Layout of the exercises page with a video, audio, and written instructions. c Exercise protocol rules with gamification components

Fig. 3

Study recruitment flowchart and calculated rates

Fig. 4

Number of sessions completed by the intervention group participants using SOPeD between baseline and T12

Fig. 5

Participant’s satisfaction with the exercise protocol (n = 6). Scores are shown on a 5-point Likert scale. Data are shown as median and interquartile range. Statement number: (1) How satisfied were you with the exercise presentation and clarity? (2) How safe did you feel when performing the exercises without supervision? (3) How satisfied were you with the privacy guaranteed by the SOPeD terms of use? (4) How satisfied were you with the opportunity to express your opinion about the SOPeD? (5) How satisfied were you with the possibility of performing the exercises at flexible and convenient times? (6) How satisfied were you with your feet health after using the SOPeD? (7) How satisfied were you with the SOPeD ability to encourage the continuation of exercising? (8) What was your general satisfaction with the SOPeD? (9) Would you recommend the SOPeD to other people with DM?