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Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training

U

U.S. Department of Education

Status and phase

Unknown
Phase 1

Conditions

Stroke
Hemiparesis

Treatments

Device: Lokomat (Robotic Orthosis) combined with slat belt treadmill

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00075283
IRB 2002-427
H133E020724

Details and patient eligibility

About

The overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.

Full description

Subjects enrolled into the study will be randomly assigned to one of 2 groups. The first group will receive one hour of conventional gait training, consisting of lower extremity strengthening exercises, stretching, and full weight bearing walking as tolerated, with appropriate physical assistance from a therapist. The second group will receive walking therapy using a Lokomat, which is a special treadmill that works in conjunction with 2 light-weight robotic arms that assists the subject to move their legs while they try to walk on the treadmill. Some of the subject's body-weight will be supported using a harness. During Lokomat training sessions, subjects will receive feedback of their walking performance on a computer monitor to help them walk. Both groups will be trained for 8-10 weeks, 3 times per week, for 1 hour training sessions (24 total sessions). Resources for transportation to the National Rehabilitation Hospital will be provided to all study participants.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  • Unilateral brain lesion.
  • Within 6 months post-stroke.
  • Receiving no other therapy targeting function of lower limb.
  • Demonstration of hemiparesis (motor dysfunction in lower limb).
  • Able to walk 5 meters without therapist assistance (walking device only).
  • Able to follow commands and protocol.

Exclusion:

  • Significant cognitive or communication impairments.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes.
  • Clinical depression.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Cheryl M Lacsamana, BBE

Data sourced from clinicaltrials.gov

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