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Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty. The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up) The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Universidade de São Paulo
São Paulo, Brazil
Start Date
August 1, 2016
Primary Completion Date
December 1, 2019
Completion Date
December 1, 2020
Last Updated
December 27, 2024
78
ACTUAL participants
Intervention Group
OTHER
Lead Sponsor
University of Sao Paulo General Hospital
NCT07425275
NCT06483620
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03594344