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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-Low | Experimental | low-dose mechanically-assisted upper limb therapy |
|
| Robot-High | Experimental | high-dose mechanically-assisted upper limb therapy |
|
| Control | Active Comparator | additional traditional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-Low | Other | 1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Score Change Immediately Following Study Intervention. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FIM Score Immediately Following Study Intervention. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Unable to follow instructions; medically unstable.
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| Name | Affiliation | Role |
|---|---|---|
| Charles Burgar, MD | Central Texas Veterans Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States | ||
| VA Greater Los Angeles Healthcare System, West LA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21674393 | Result | Burgar CG, Lum PS, Scremin AM, Garber SL, Van der Loos HF, Kenney D, Shor P. Robot-assisted upper-limb therapy in acute rehabilitation setting following stroke: Department of Veterans Affairs multisite clinical trial. J Rehabil Res Dev. 2011;48(4):445-58. doi: 10.1682/jrrd.2010.04.0062. |
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4 subjects excluded from group assignment due to medical conditions that precluded moderate-workload exercise.
Enrollment: November 2002 - December 2004 Enrollment sites: Michael E. DeBakey VA Medical Center, Houston, TX; VA Greater Los Angeles Healthcare System, Los Angeles, CA; and VA Palo Alto Health Care System, Palo Alto, CA. Data analysis site: Central Texas Veterans Health Care System, Temple, TX.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robot-Low | Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy |
| FG001 | Robot-High | Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy |
| FG002 | Control | Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robot-Low | Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy |
| BG001 | Robot-High |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer Score Change Immediately Following Study Intervention. | 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. | Posted | Mean | Standard Error | units on a scale | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robot-Low | Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy |
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Limitations include the relatively small number of subjects in each group and the variation in severity level across subjects. Subjects at the Houston site were enrolled earlier after stroke than in the LA site and the Palo Alto site.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Burgar, MD | CTVHCS | 254/743-0085 | charles.burgar1@va.gov |
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| Robot-High | Other | 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy |
|
| Control | Other | 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot |
|
| 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 | 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. |
| West Los Angeles |
| California |
| 90073 |
| United States |
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | United States |
| Central Texas Veterans Health Care System | Temple | Texas | 76504 | United States |
Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
| BG002 | Control | Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Robot-Low | Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15. |
| OG001 | Robot-High | Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30. |
| OG002 | Control | Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15. |
|
|
| Primary | Fugl-Meyer Score Change at 6 Months | Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66. | A total of 37 subjects returned for the 6-month follow-up evaluations. | Posted | Mean | Standard Error | units on a scale | 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 | Change in FIM Score Immediately Following Study Intervention. | 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. | Posted | Mean | Standard Error | units on a scale | 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. |
|
|
|
| Secondary | Change in FIM Score at 6-months | Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63 . | A total of 37 subjects returned for the 6-month follow-up evaluations. | Posted | Mean | Standard Error | units on a scale | 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. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Robot-High | Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy | 0 | 23 | 0 | 23 |
| EG002 | Control | Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot | 0 | 22 | 0 | 22 |
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| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |