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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebrovascular Disorders Hemiplegia | Other: Robot-Low Other: Robot-High Other: Control | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Robot-Low
low-dose mechanically-assisted upper limb therapy
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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
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Other: Robot-High
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy |
Active Comparator: Control
additional traditional therapy
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Other: Control
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot |
- 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.
- 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.
- 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.
- 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
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Principal Investigator: | Charles Burgar, MD | Central Texas Veterans Health Care System |
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 |
Rehabilitation Robotics |
Hemiplegia Cerebrovascular Disorders Paralysis Neurologic Manifestations Nervous System Diseases |
Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases |