Trial Outcomes & Findings for Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial (NCT NCT00223808)
NCT ID: NCT00223808
Last Updated: 2014-02-17
Results Overview
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.
COMPLETED
PHASE3
71 participants
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.
2014-02-17
Participant Flow
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.
4 subjects excluded from group assignment due to medical conditions that precluded moderate-workload exercise.
Participant milestones
| Measure |
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
|
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
|
Control
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
23
|
|
Overall Study
COMPLETED
|
19
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
5
|
Reasons for withdrawal
| Measure |
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
|
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
|
Control
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
|
|---|---|---|---|
|
Overall Study
<5 hrs therapy before discharge
|
3
|
5
|
5
|
Baseline Characteristics
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Baseline characteristics by cohort
| Measure |
Robot-Low
n=22 Participants
Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
|
Robot-High
n=22 Participants
Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
|
Control
n=23 Participants
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Age, Continuous
|
62.95 years
STANDARD_DEVIATION 8.34 • n=99 Participants
|
59.04 years
STANDARD_DEVIATION 9.30 • n=107 Participants
|
67.87 years
STANDARD_DEVIATION 12.56 • n=206 Participants
|
63.36 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
23 participants
n=206 Participants
|
67 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Robot-Low
n=19 Participants
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.
|
Robot-High
n=17 Participants
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.
|
Control
n=18 Participants
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.
|
|---|---|---|---|
|
Fugl-Meyer Score Change Immediately Following Study Intervention.
|
6.8 units on a scale
Standard Error 1.9
|
14.4 units on a scale
Standard Error 3.6
|
14.0 units on a scale
Standard Error 3.6
|
PRIMARY outcome
Timeframe: 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.
Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.
Outcome measures
| Measure |
Robot-Low
n=14 Participants
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.
|
Robot-High
n=11 Participants
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.
|
Control
n=12 Participants
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.
|
|---|---|---|---|
|
Fugl-Meyer Score Change at 6 Months
|
15.9 units on a scale
Standard Error 3.5
|
23.6 units on a scale
Standard Error 5.8
|
15.3 units on a scale
Standard Error 4.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Robot-Low
n=19 Participants
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.
|
Robot-High
n=17 Participants
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.
|
Control
n=18 Participants
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.
|
|---|---|---|---|
|
Change in FIM Score Immediately Following Study Intervention.
|
17.7 units on a scale
Standard Error 1.9
|
21.5 units on a scale
Standard Error 2.1
|
15.9 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 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.
Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63 .
Outcome measures
| Measure |
Robot-Low
n=14 Participants
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.
|
Robot-High
n=11 Participants
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.
|
Control
n=12 Participants
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.
|
|---|---|---|---|
|
Change in FIM Score at 6-months
|
24.2 units on a scale
Standard Error 2.9
|
27.5 units on a scale
Standard Error 3.0
|
26.8 units on a scale
Standard Error 3.1
|
Adverse Events
Robot-Low
Robot-High
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place