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

NCT ID: NCT00075283

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

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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

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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.

Conditions

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Hemiparesis Stroke

Keywords

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Physical Therapy Locomotion therapy Gait training Stroke Robotics Rehabilitation Treadmill Hemiparetic stroke Unilateral brain lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lokomat (Robotic Orthosis) combined with slat belt treadmill

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role lead

Principal Investigators

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Dr. Joseph M Hidler, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of America

Locations

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National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cheryl M Lacsamana, BBE

Role: CONTACT

Phone: (202)877-1889

Email: [email protected]

Facility Contacts

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Cheryl M Lacsamana, BBE

Role: primary

Other Identifiers

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IRB 2002-427

Identifier Type: -

Identifier Source: secondary_id

H133E020724

Identifier Type: -

Identifier Source: org_study_id