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

Autor(es)

Cruvinel Junior, Ronaldo H. ^[1] ; Ferreira, Jane S. S. P. ^[1] ; Beteli, I, Raquel ; Silva, Erica Q. ^[2] ; Verissimo, Jady L. ^[2] ; Monteiro, Renan L. ^{[3, 2]} ; Suda, Eneida Y. ^{[4, 2]} ; Sacco, Isabel C. N. ^[2]

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Sch Med, Dept Phys Therapy Speech & Occupat Therapy, Rua Cipotanea 51, Cidade Univ, BR-05360160 Sao Paulo, SP - Brazil

^[2] Beteli, Raquel, I, Univ Sao Paulo, Sch Med, Dept Phys Therapy Speech & Occupat Therapy, Rua Cipotanea 51, Cidade Univ, BR-05360160 Sao Paulo, SP - Brazil

^[3] Univ Fed Amapa, Dept Phys Therapy, Amapa - Brazil

^[4] Univ Ibirapuera, Dept Phys Therapy, Sao Paulo, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: PILOT AND FEASIBILITY STUDIES; v. 7, n. 1 MAR 26 2021.
• Citações Web of Science: 0

Resumo

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 Orientacao ao Pe diabetico - 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. (AU)

• Processo FAPESP: 17/15449-4 - Biomecânica e aspectos funcionais do sistema musculoesquelético de corredores: efeito crônico de exercícios terapêuticos e do envelhecimento
• Beneficiário: Eneida Yuri Suda
• Modalidade de apoio: Bolsas no Brasil - Pós-Doutorado
• Processo FAPESP: 19/06405-9 - Tecnologia de reabilitação para prevenção de disfunções musculoesqueléticas e tratamento dos pés de pessoas com diabetes mellitus: estudo FOotCAre (FOCA) prova de conceito
• Beneficiário: Ronaldo Henrique Cruvinel Júnior
• Modalidade de apoio: Bolsas no Brasil - Mestrado
• Processo FAPESP: 19/02522-0 - Tecnologia de reabilitação para prevenção de disfunções musculoesqueléticas e dos pés de pessoas com Diabetes Mellitus: ensaio FootCAre (FoCa) preventivo controlado randomizado
• Beneficiário: Jane Suelen Silva Pires Ferreira
• Modalidade de apoio: Bolsas no Brasil - Doutorado
• Processo FAPESP: 17/17848-3 - Efeitos do fortalecimento dos músculos dos pés na atividade física de vida diária e funcionalidade de tornozelo e pé de pessoas com polineuropatia diabética: um ensaio clínico controlado randomizado
• Beneficiário: Renan Lima Monteiro
• Modalidade de apoio: Bolsas no Brasil - Doutorado