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

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Diabetic Neuropathies

Treatments

Other: Intervention Group

Study type

Interventional

Funder types

Other

Identifiers

NCT02790931
LaBiMPH

Details and patient eligibility

About

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

Full 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.

Enrollment

78 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

78 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months.
Treatment:
Other: Intervention Group
Control Group
No Intervention group
Description:
Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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