Universidade de São Paulo
São Paulo, 05360-160, Brazil
NCT Number: NCT02790931
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
São Paulo, 05360-160, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 weeks
Calculate the number of steps per week
Time frame: 12 weeks
self selected gait speed shod walking velocity in a walkway
Time frame: 12 weeks
Fast gait speed shod walking velocity in a walkway
Time frame: 12 weeks
Score of the classification of the plantar ulcer risk (IWG diabetic foot)
Time frame: 12 weeks
Score of the Foot Health Status questionnaire - BRAZIL
Time frame: 12 weeks
Hallux and lesser toes force measured by a pressure plate
Time frame: baseline, 12 weeks
Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait
Time frame: baseline, 12 weeks
Peak joint moment and eccentric and concentric power by inverse dynamic calculations
Time frame: 12 months
New cases of foot plantar ulcers
Time frame: 12 weeks
Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament
Time frame: 12 weeks
Evaluation of the vibration sensitivity with tuning fork
Time frame: 12 weeks
Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)
Time frame: 12 weeks
Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.
Time frame: 12 weeks
EQ-5D score of the quality of life of the patient
University of Sao Paulo General Hospital
Other
Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
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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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