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NCT02790931 | COMPLETED | Diabetic Neuropathies

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

University of Sao Paulo General Hospital

Information provided by (Responsible Party):

Isabel de Camargo Neves Sacco

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.

Condition or disease

Diabetic Neuropathies

Intervention/treatment

Intervention Group

Phase

NA

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
Estimated Enrollment : 78 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
Actual Study Start Date : 2016-08
Estimated Primary Completion Date : 2019-12
Estimated Study Completion Date : 2020-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

Location Details

NCT02790931

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Brazil,

University of São Paulo

São Paulo, Brazil, 05360-160