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

Sponsor
U.S. Department of Education (U.S. Fed)
Overall Status
Unknown status
CT.gov ID
NCT00075283
Collaborator
(none)
50
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Lokomat (Robotic Orthosis) combined with slat belt treadmill
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training
Study Start Date :
Nov 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Rehabilitation Hospital Washington District of Columbia United States 20010

    Sponsors and Collaborators

    • U.S. Department of Education

    Investigators

    • Principal Investigator: Dr. Joseph M Hidler, Ph.D., The Catholic University of America

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00075283
    Other Study ID Numbers:
    • H133E020724
    • IRB 2002-427
    First Posted:
    Jan 9, 2004
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jan 1, 2004

    Study Results

    No Results Posted as of Jun 24, 2005