Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00223808

Purpose

The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.

Condition	Intervention	Phase
Cerebrovascular Disorders Hemiplegia	Device: Mechanically-assisted upper limb exercise using MIME Device: Mechanically-assisted upper limb exercise using MIME (high-dose) Device: Additional usual therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Fugl-Meyer score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2002
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 low-dose mechanically-assisted upper limb movement therapy	Device: Mechanically-assisted upper limb exercise using MIME 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
Experimental: 2 high-dose mechanically-assisted upper limb movement therapy	Device: Mechanically-assisted upper limb exercise using MIME (high-dose) 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
Active Comparator: 3 traditional therapy	Device: Additional usual therapy 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot

Detailed Description:

This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention.Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR&DC), and the Central Texas Veterans Health Care System (CTVHCS). CTVHCS serves as the coordinating site. The RR&DC provides training and technical assistance for the other sites. Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups. Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Group 2 receives a total of 2 hours/day of robot-assisted therapy. Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223808

Locations

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Charles Burgar, MD

Central Texas Veterans Health Care System

More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Burgar CG, Lum PS, Scremin AM, Garber SL, Van der Loos HF, Kenney D, Shor P. Robot-assisted upper-limb therapy in acute rehabilitation setting following stroke: Department of Veterans Affairs multisite clinical trial. J Rehabil Res Dev. 2011;48(4):445-58.

Responsible Party:	Burgar, Charles - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00223808 History of Changes
Obsolete Identifiers:	NCT00038324
Other Study ID Numbers:	B2695I
Study First Received:	September 14, 2005
Last Updated:	September 17, 2009
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Rehabilitation
Robotics

Additional relevant MeSH terms:

Cerebrovascular Disorders
Hemiplegia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012