Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
January 3, 2014 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System
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West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West LA
-
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Texas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center (152)
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Temple, Texas, United States, 76504
- Central Texas Veterans Health Care System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Robot-Low
low-dose mechanically-assisted upper limb therapy
|
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
|
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
|
|
Active Comparator: Control
additional traditional therapy
|
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 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 . |
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Charles Burgar, MD, Central Texas Veterans Health Care System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 17, 2014
Last Update Submitted That Met QC Criteria
January 3, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2695-I
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