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Completed

NCT Number: NCT02790931

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group

Other

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

Primary outcomes

  1. Daily Physical Activity

    Time frame: 12 weeks

    Calculate the number of steps per week

  2. Self Selected Gait Speed

    Time frame: 12 weeks

    self selected gait speed shod walking velocity in a walkway

  3. Fast Gait Speed

    Time frame: 12 weeks

    Fast gait speed shod walking velocity in a walkway

Secondary outcomes

  1. Risk Classification of Plantar Ulceration

    Time frame: 12 weeks

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

  2. Foot Health and Functionality

    Time frame: 12 weeks

    Score of the Foot Health Status questionnaire - BRAZIL

  3. Foot Strength

    Time frame: 12 weeks

    Hallux and lesser toes force measured by a pressure plate

  4. 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

  5. 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

  6. Plantar Ulcers

    Time frame: 12 months

    New cases of foot plantar ulcers

  7. Tactile Sensitivity

    Time frame: 12 weeks

    Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament

  8. Vibration Sensitivity

    Time frame: 12 weeks

    Evaluation of the vibration sensitivity with tuning fork

  9. Neuropathy Symptoms

    Time frame: 12 weeks

    Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)

  10. 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.

  11. EQ-5D Score

    Time frame: 12 weeks

    EQ-5D score of the quality of life of the patient

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 6, 2016
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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