Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training
Recruitment status was Recruiting
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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 Endpoint Classification: Efficacy Study 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2002 |
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 |
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| Contact: Cheryl M Lacsamana, BBE | (202)877-1889 | cheryl.lacsamana@medstar.net |
| 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. | |
| Principal Investigator: | Dr. Joseph M Hidler, Ph.D. | The Catholic University of America |
More Information
No publications provided
| 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 |
| Health Authority: | United States: Federal Government |
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:
|
Paresis Stroke Cerebral Infarction Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013