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

April 2, 2024 updated by: Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05360-160
        • Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months.
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.
Other Names:
  • Foot and ankle kinesiotherapy
No Intervention: Control Group
Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Physical Activity
Time Frame: 12 weeks
Calculate the number of steps per week
12 weeks
Self Selected Gait Speed
Time Frame: 12 weeks
self selected gait speed shod walking velocity in a walkway
12 weeks
Fast Gait Speed
Time Frame: 12 weeks
Fast gait speed shod walking velocity in a walkway
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Classification of Plantar Ulceration
Time Frame: 12 weeks
Score of the classification of the plantar ulcer risk (IWG diabetic foot)
12 weeks
Foot Health and Functionality
Time Frame: 12 weeks
Score of the Foot Health Status questionnaire - BRAZIL
12 weeks
Foot Strength
Time Frame: 12 weeks
Hallux and lesser toes force measured by a pressure plate
12 weeks
Foot and Ankle Kinematics During Gait
Time Frame: baseline, 12 weeks
Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait
baseline, 12 weeks
Ankle and Knee Joint Moments and Power During Gait
Time Frame: baseline, 12 weeks
Peak joint moment and eccentric and concentric power by inverse dynamic calculations
baseline, 12 weeks
Plantar Ulcers
Time Frame: 12 months
New cases of foot plantar ulcers
12 months
Tactile Sensitivity
Time Frame: 12 weeks
Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament
12 weeks
Vibration Sensitivity
Time Frame: 12 weeks
Evaluation of the vibration sensitivity with tuning fork
12 weeks
Neuropathy Symptoms
Time Frame: 12 weeks
Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)
12 weeks
Range of Motion
Time Frame: 12 weeks
Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.
12 weeks
EQ-5D Score
Time Frame: 12 weeks
EQ-5D score of the quality of life of the patient
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Isabel CN Sacco, PhD, Associate Professor at São Paulo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimated)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaBiMPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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