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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Other: Intervention Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. | Other: Intervention Group<br>* 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.<br>* Other names: Foot and ankle kinesiotherapy;|
| No Intervention: Control Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily physical activity | Calculate the number of steps during 1 week | baseline, 12 weeks and 12 months | 
| Self selected gait speed | self selected gait speed shod walking velocity in a walkway | baseline,12 weeks and 12 months | 
| Fast gait speed | Fast gait speed shod walking velocity in a walkway | baseline,12 weeks and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk classification of plantar ulceration | Score of the classification of the plantar ulcer risk (IWG diabetic foot) | baseline,6, 12, 24 weeks and 12 months | 
| Foot health and functionality | Score of the Foot Health Status questionnaire - BRAZIL | baseline, 6, 12, 24 weeks and 12 months | 
| Foot strength | Hallux and lesser toes force measured by a pressure plate | baseline, 6, 12, 24 weeks and 12 months | 
| Foot and ankle Kinematics during gait | 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 | Peak joint moment and eccentric and concentric power by inverse dynamic calculations | baseline, 12 weeks | 
| Incidence of plantar ulcers | New cases of plantar ulcers | baseline, During 12 months | 
| Tactile sensitivity | Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament | baseline, 6, 12, 24 weeks and 12 months | 
| Vibration sensitivity | Evaluation of the vibration sensitivity with tuning fork | baseline, 6, 12, 24 weeks and 12 months | 
| Symptoms | Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI) | baseline, 6, 12, 24 weeks and 12 months | 
| Range of motion | Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle. | baseline, 6, 12, 24 weeks and 12 months | 
| EQ-5D score of the quality of life | EQ-5D score of the quality of life | baseline, 6, 12, 24 weeks and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot, therapeutic exercises, foot, preventive care, rehabilitation, Diabetic Neuropathy