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| 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 |
| 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 |
| 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:
Exclusion:
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
| Study ID Numbers: | H133E020724, IRB 2002-427 |
| Study First Received: | January 8, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00075283 History of Changes |
| Health Authority: | United States: Federal Government |
|
Physical Therapy Locomotion therapy Gait training Stroke Robotics |
Rehabilitation Treadmill Hemiparetic stroke Unilateral brain lesion |
|
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 |
|
Paresis Cerebral Infarction Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases |
Cerebrovascular Disorders Signs and Symptoms Neurologic Manifestations Brain Ischemia Cardiovascular Diseases Brain Infarction |