ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Assisted Movement Neuro-Rehabilitation: VA Multi-Site Clinical Trial

This study is ongoing, but not recruiting participants.

Sponsored by: 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

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

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

Keywords provided by Department of Veterans Affairs:
Rehabilitation  
Robotics  

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Hemiplegia
Vascular Diseases
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers