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

Primary Purpose

Hemiparesis, Stroke

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lokomat (Robotic Orthosis) combined with slat belt treadmill
Sponsored by
U.S. Department of Education
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis focused on measuring Physical Therapy, Locomotion therapy, Gait training, Stroke, Robotics, Rehabilitation, Treadmill, Hemiparetic stroke, Unilateral brain lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Rehabilitation HospitalRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 8, 2004
Last Updated
June 23, 2005
Sponsor
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00075283
Brief Title
Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training
Official Title
Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training
Study Type
Interventional

2. Study Status

Record Verification Date
January 2004
Overall Recruitment Status
Unknown status
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
U.S. Department of Education

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Stroke
Keywords
Physical Therapy, Locomotion therapy, Gait training, Stroke, Robotics, Rehabilitation, Treadmill, Hemiparetic stroke, Unilateral brain lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Lokomat (Robotic Orthosis) combined with slat belt treadmill

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl M Lacsamana, BBE
Phone
(202)877-1889
Email
cheryl.lacsamana@medstar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Joseph M Hidler, Ph.D.
Organizational Affiliation
The Catholic University of America
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl M Lacsamana, BBE
Phone
202-877-1889
Email
cheryl.lacsamana@medstar.net
First Name & Middle Initial & Last Name & Degree
Dr. Joseph M Hidler, Ph.D.

12. IPD Sharing Statement

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

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