Cerebral Stroke, Cerebrovascular Accident, Stroke
Conditions
Keywords
Motor Learning, Rehabilitation, Robotics, Therapeutic Electric Stimulation
Brief summary
The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.
Detailed description
Methods. Up to ninety-six chronic stroke subjects (\> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.
Interventions
DEVICERobotics training for shoulder elbow.
training utilizing a robot to assist with movement practice
DEVICESurface Functional Neuromuscular Stimulation
training utilizing FNS to assist with movement practice
OTHERwhole arm motor learning
intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Medically stable and at least 12 months post stroke. * Difficulty using upper limb for functional tasks. * Age \>21 years
Exclusion criteria
uncontrolled, chronic medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMAT | prior to treatment and following 3 months of treatment | The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test. |
| M1 Activation Absolute Change Score | at baseline and following 3 months of treatment | A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by word of mouth and from an advertisement flyer.
Participants by arm
| Arm | Count |
|---|---|
| Shoulder/Elbow Robotics + Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow \> wrist hand. | 11 |
| Wrist/Hand FES + Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand \>shoulder/elbow | 11 |
| Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand | 18 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Shoulder/Elbow Robotics + Whole Arm Motor Learning | Wrist/Hand FES + Whole Arm Motor Learning | Whole Arm Motor Learning | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 5 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 13 Participants | 31 Participants |
| Region of Enrollment United States | 11 participants | 11 participants | 18 participants | 40 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants | 28 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 / 11 | 0 / 11 | 0 / 18 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 18 |
Outcome results
Primary
AMAT
The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.
Time frame: prior to treatment and following 3 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shoulder/Elbow Robotics+Whole Arm Motor Learning | AMAT | Pre Treatment AMAT | 1693 seconds | Standard Deviation 631 |
| Shoulder/Elbow Robotics+Whole Arm Motor Learning | AMAT | Post Treatment AMAT | 1386 seconds | Standard Deviation 572 |
| Wrist/Hand FES+Whole Arm Motor Learning | AMAT | Pre Treatment AMAT | 1693 seconds | Standard Deviation 947 |
| Wrist/Hand FES+Whole Arm Motor Learning | AMAT | Post Treatment AMAT | 1341 seconds | Standard Deviation 900 |
| Whole Arm Motor Learning Group | AMAT | Pre Treatment AMAT | 1556 seconds | Standard Deviation 703 |
| Whole Arm Motor Learning Group | AMAT | Post Treatment AMAT | 1187 seconds | Standard Deviation 703 |
Primary
M1 Activation Absolute Change Score
A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.
Time frame: at baseline and following 3 months of treatment
Population: This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shoulder/Elbow Robotics+Whole Arm Motor Learning | M1 Activation Absolute Change Score | 359.6 voxels | Standard Deviation 323.3 |
| Wrist/Hand FES+Whole Arm Motor Learning | M1 Activation Absolute Change Score | 489.88 voxels | Standard Deviation 505.8 |
| Whole Arm Motor Learning Group | M1 Activation Absolute Change Score | 429.7 voxels | Standard Deviation 327.2 |