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

This study is currently recruiting participants.
Verified by Department of Education, January 2004

Sponsored by: Department of Education
Information provided by: Department of Education
ClinicalTrials.gov Identifier: NCT00075283
  Purpose

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 Intervention Phase
Hemiparesis
Stroke
Device: Lokomat (Robotic Orthosis) combined with slat belt treadmill
Phase I

MedlinePlus related topics:   Rehabilitation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training

Further study details as provided by Department of Education:

Estimated Enrollment:   50
Study Start Date:   November 2002

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075283

Contacts
Contact: Cheryl M Lacsamana, BBE     (202)877-1889     cheryl.lacsamana@medstar.net    

Locations
United States, District of Columbia
National Rehabilitation Hospital     Recruiting
      Washington, District of Columbia, United States, 20010
      Contact: Cheryl M Lacsamana, BBE     202-877-1889     cheryl.lacsamana@medstar.net    
      Principal Investigator: Dr. Joseph M Hidler, Ph.D.            

Sponsors and Collaborators
Department of Education

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


Website of research lab  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   H133E020724, IRB 2002-427
First Received:   January 8, 2004
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00075283
Health Authority:   United States: Federal Government

Keywords provided by Department of Education:
Physical Therapy  
Locomotion therapy  
Gait training  
Stroke  
Robotics  
Rehabilitation
Treadmill
Hemiparetic stroke
Unilateral brain lesion

Study placed in the following topic categories:
Paresis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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