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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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 1

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

Further study details as provided by U.S. 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00075283     History of Changes
Other Study ID Numbers: H133E020724
IRB 2002-427
Study First Received: January 8, 2004
Last Updated: June 23, 2005

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

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 27, 2017