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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intervention Group	Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months.

Primary Outcome Measures

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

Secondary Outcome Measures

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