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

Further Study Details: 

Expected Total Enrollment:  50

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.
• Unontrolled diabetes.
• Clinical depression.

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

District of Columbia
      National Rehabilitation Hospital, Washington,  District of Columbia,  20010,  United States; Recruiting

Study chairs or principal investigators

Dr. Joseph M Hidler, Ph.D.,  Principal Investigator,  The Catholic University of America   

Study ID Numbers:  H133E020724; IRB 2002-427
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  January 8, 2004
ClinicalTrials.gov Identifier:  NCT00075283
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08