Cerebrovascular Disorders, Hemiplegia
Conditions
Keywords
Rehabilitation, Robotics
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.
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.
Interventions
OTHERRobot-Low
1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
OTHERRobot-High
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
OTHERControl
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Score Change Immediately Following Study Intervention. | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in FIM Score Immediately Following Study Intervention. | 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 | 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 . |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
4 subjects excluded from group assignment due to medical conditions that precluded moderate-workload exercise.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 22 |
| Control Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot | 23 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | <5 hrs therapy before discharge | 3 | 5 | 5 |
Baseline characteristics
| Characteristic | Robot-High | Control | Robot-Low | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 13 Participants | 6 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 10 Participants | 16 Participants | 45 Participants |
| Age, Continuous | 59.04 years STANDARD_DEVIATION 9.3 | 67.87 years STANDARD_DEVIATION 12.56 | 62.95 years STANDARD_DEVIATION 8.34 | 63.36 years STANDARD_DEVIATION 10.75 |
| Region of Enrollment United States | 22 participants | 23 participants | 22 participants | 67 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 21 Participants | 23 Participants | 22 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 | 0 / 22 |
Outcome results
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.
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.
Population: A total of 37 subjects returned for the 6-month follow-up evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-Low | Fugl-Meyer Score Change at 6 Months | 15.9 units on a scale | Standard Error 3.5 |
| Robot-High | Fugl-Meyer Score Change at 6 Months | 23.6 units on a scale | Standard Error 5.8 |
| Control | Fugl-Meyer Score Change at 6 Months | 15.3 units on a scale | Standard Error 4.9 |
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-Low | Fugl-Meyer Score Change Immediately Following Study Intervention. | 6.8 units on a scale | Standard Error 1.9 |
| Robot-High | Fugl-Meyer Score Change Immediately Following Study Intervention. | 14.4 units on a scale | Standard Error 3.6 |
| Control | Fugl-Meyer Score Change Immediately Following Study Intervention. | 14.0 units on a scale | Standard Error 3.6 |
Secondary
Change in FIM Score at 6-months
Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63 .
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.
Population: A total of 37 subjects returned for the 6-month follow-up evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-Low | Change in FIM Score at 6-months | 24.2 units on a scale | Standard Error 2.9 |
| Robot-High | Change in FIM Score at 6-months | 27.5 units on a scale | Standard Error 3 |
| Control | Change in FIM Score at 6-months | 26.8 units on a scale | Standard Error 3.1 |
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-Low | Change in FIM Score Immediately Following Study Intervention. | 17.7 units on a scale | Standard Error 1.9 |
| Robot-High | Change in FIM Score Immediately Following Study Intervention. | 21.5 units on a scale | Standard Error 2.1 |
| Control | Change in FIM Score Immediately Following Study Intervention. | 15.9 units on a scale | Standard Error 1.5 |