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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by U.S. Department of Education.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
U.S. Department of Education
ClinicalTrials.gov Identifier:
NCT00075283
First received: January 8, 2004
Last updated: June 23, 2005
Last verified: January 2004

January 8, 2004
June 23, 2005
November 2002
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Complete list of historical versions of study NCT00075283 on ClinicalTrials.gov Archive Site
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Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training
Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hemiparesis
  • Stroke
Device: Lokomat (Robotic Orthosis) combined with slat belt treadmill
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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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.
Both
18 Years and older
No
Contact: Cheryl M Lacsamana, BBE (202)877-1889 cheryl.lacsamana@medstar.net
United States
 
NCT00075283
H133E020724, IRB 2002-427
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U.S. Department of Education
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Principal Investigator: Dr. Joseph M Hidler, Ph.D. The Catholic University of America
U.S. Department of Education
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP