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

Stroke Clinical Trial

Official title:

Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00075283
• Other study ID #: H133E020724
• Secondary ID: IRB 2002-427
• Status: Recruiting
• Phase: Phase 1
• First received: January 8, 2004
• Last updated: June 23, 2005
• Start date: November 2002

Study information

• Verified date: January 2004
• Source: U.S. Department of Education
• Contact: Cheryl M Lacsamana, BBE
• Phone: (202)877-1889
• Email: cheryl.lacsamana[@]medstar.net
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Stroke

Intervention

Device:
• Lokomat (Robotic Orthosis) combined with slat belt treadmill

Locations

Country	Name	City	State
United States	National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Department of Education

Country where clinical trial is conducted

United States,