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Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

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ClinicalTrials.gov Identifier: NCT00223808
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cerebrovascular Disorders Hemiplegia Other: Robot-Low Other: Robot-High Other: Control Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Study Start Date : January 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Robot-Low
low-dose mechanically-assisted upper limb therapy
 Other: Robot-Low
1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
Experimental: Robot-High
high-dose mechanically-assisted upper limb therapy
 Other: Robot-High
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
Active Comparator: Control
additional traditional therapy
 Other: Control
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot


Outcome Measures
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Primary Outcome Measures :
  1. Fugl-Meyer Score Change Immediately Following Study Intervention. [ Time Frame: After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke. ]
    Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.

  2. Fugl-Meyer Score Change at 6 Months [ Time Frame: FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke. ]
    Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.


Secondary Outcome Measures :
  1. Change in FIM Score Immediately Following Study Intervention. [ Time Frame: After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke. ]
    Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.

  2. Change in FIM Score at 6-months [ Time Frame: Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke. ]

    Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63

    .



Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223808


Locations
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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
US Department of Veterans Affairs
Investigators
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Principal Investigator: Charles Burgar, MD Central Texas Veterans Health Care System
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223808    
Obsolete Identifiers: NCT00038324
Other Study ID Numbers: B2695-I
First Posted: September 22, 2005    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014
Last Verified: January 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Rehabilitation
Robotics
Additional relevant MeSH terms:
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Hemiplegia
Cerebrovascular Disorders
Paralysis
Neurologic Manifestations
Nervous System Diseases
 Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases