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

University of Sao Paulo General Hospital78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Neuropathies

Interventions

Intervention GroupOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes mellitus type 1 or 2 * Moderate or severe polyneuropathy confirmed with the fuzzy software * Ability to walk independently in the laboratory * Accessibility to electronic devices * Loss of at least 4 degrees of ankle range of motion * Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles Exclusion Criteria: * Ulceration not healed for at least 6 months * Hallux amputation or total amputation of the foot * Receiving any physiotherapy intervention or offloading devices * Neurological or orthopedic impairments * Major vascular complications * Severe retinopathy

Locations (1)

Universidade de São Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

Daily Physical Activity

Calculate the number of steps per week

Time frame: 12 weeks

Self Selected Gait Speed

self selected gait speed shod walking velocity in a walkway

Time frame: 12 weeks

Fast Gait Speed

Fast gait speed shod walking velocity in a walkway

Time frame: 12 weeks

Secondary Outcomes

Risk Classification of Plantar Ulceration

Score of the classification of the plantar ulcer risk (IWG diabetic foot)

Time frame: 12 weeks

Foot Health and Functionality

Score of the Foot Health Status questionnaire - BRAZIL

Time frame: 12 weeks

Foot Strength

Hallux and lesser toes force measured by a pressure plate

Time frame: 12 weeks

Foot and Ankle Kinematics During Gait

Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait

Time frame: baseline, 12 weeks

Ankle and Knee Joint Moments and Power During Gait

Peak joint moment and eccentric and concentric power by inverse dynamic calculations

Time frame: baseline, 12 weeks

Plantar Ulcers

Data from ClinicalTrials.gov

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