Full Text View
Tabular View
No Study Results Posted
Related Studies
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
This study has been completed.
Study NCT00223808   Information provided by Department of Veterans Affairs
First Received: September 14, 2005   Last Updated: September 17, 2009   History of Changes

September 14, 2005
September 17, 2009
January 2002
July 2008   (final data collection date for primary outcome measure)
Fugl-Meyer score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Motor control at intake, discharge, 6 and 12 months.
Complete list of historical versions of study NCT00223808 on ClinicalTrials.gov Archive Site
 
Strength, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.
 
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
  • 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
  • Experimental: low-dose mechanically-assisted upper limb movement therapy
  • Experimental: high-dose mechanically-assisted upper limb movement therapy
  • Active Comparator: traditional therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
July 2008
July 2008   (final data collection date for primary outcome measure)

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.

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00223808
Burgar, Charles - Principal Investigator, Department of Veterans Affairs
B2695I
Department of Veterans Affairs
 
Principal Investigator: Charles Burgar, MD Central Texas Veterans Health Care System
Department of Veterans Affairs
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP