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Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy

NCT04011267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-03-03

No results posted yet for this study

Summary

The main objective of this trial is to investigate the effect of a customized foot-related exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.

Conditions

  • Diabetic Neuropathies

Interventions

OTHER

Physical therapy by foot-ankle segmental and functional exercises

The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Isabel de Camargo Neves Sacco, PhD · Associate Professor at São Paulo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011267 on ClinicalTrials.gov