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

Pilot and Feasibility Studies

Ronaldo H. Cruvinel Júnior¹  Jady L. Veríssimo¹  Érica Q. Silva¹  Isabel C. N. Sacco¹  Jane S. S. P. Ferreira¹  Raquel I. Beteli¹  Renan L. Monteiro²  Eneida Y. Suda³ 

[1] Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, 05360-160, São Paulo, São Paulo, Brazil;Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, 05360-160, São Paulo, São Paulo, Brazil;Department of Physical Therapy, Federal University of Amapá, Amapá, Brazil;Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, 05360-160, São Paulo, São Paulo, Brazil;Department of Physical Therapy, Ibirapuera University, São Paulo, SP, Brazil;

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

DOI  :  10.1186/s40814-021-00826-y

来源: Springer

【 摘 要 】

BackgroundDiabetic 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).MethodsFourteen 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.ResultsIn 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).ConclusionThe 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 registrationClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

【 授权许可】

CC BY