NCT02790931

Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

Detailed description

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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
OTHER	Intervention Group	Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2016-06-06
• Last updated: 2024-12-27
• Results posted: 2024-04-04

Locations

1 site across 1 country: Brazil