Assisted Movement Neuro-Rehabilitation: VA Multi-Site Clinical Trial - Full Text View

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

MedlinePlus related topics:

Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study

Official Title:	Assisted Movement Neuro-Rehabilitation: VA Multi-Site Clinical Trial

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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
3: Active Comparator 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 Greater Los Angeles Healthcare System, West LA
	West Los Angeles, California, United States, 90073
	VA Palo Alto Health Care System
	Palo Alto, California, United States, 94304-1290

United States, Texas
	Central Texas Veterans Health Care System
	Temple, Texas, United States, 76504
	Michael E. DeBakey VA Medical Center (152)
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Charles Burgar, MD	Central Texas Veterans Health Care System

More Information

Responsible Party:	Department of Veterans Affairs ( Burgar, Charles - Principal Investigator )
Study ID Numbers:	B2695I
First Received:	September 14, 2005
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00223808
Health Authority:	United States: Federal Government