CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Educational and home-based physical therapy by foot-related exercisesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04008745
NCT04008745N/ACompleted

Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial

University of Sao Paulo General Hospital·interventional·Posted Jul 5, 2019·Updated Sep 19, 2024

In Brief

A clinical study evaluating Educational and home-based physical therapy by foot-related exercises for Diabetic Neuropathies. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartMay 1, 2019
Primary CompletionMay 1, 2021
Study CompletionNov 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 7.0 years ago

Interventions

Educational and home-based physical therapy by foot-related exercisesother

The booklet is divided in 2: educational and exercise protocol. The aim of the first part is to guide the individual for a change in his/her health behavior, and comprises info about diabetic neuropathy, foot care, shoes, and benefits of exercising. The second part is the foot protocol, composed by 6 exercises. The maximum duration of a session is 20min and should be performed 3 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the booklet, filling a table with the effort perceived (effort likert scale). The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression, which is also registered by the participant in the monthly table at the booklet.