This study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.
Research has shown that robot-assisted therapy can help people regain control of simple reaching or grasping movements, but these improvements don't generalize well to use of the weaker limb during everyday tasks. This study aims to refine and test a protocol named the Active Learning Program for Stroke (ALPS), which teaches people to use active problem solving strategies and a home program to improve function. Therapist-delivered ALPS instruction may incorporate use of strategies (e.g. STOP, THINK, DO, CHECK) modeled after the Cognitive Orientation for daily Occupational Performance (CO-OP) approach to improve real-world use of the paretic upper limb. We will evaluate whether the combination of robot-assisted therapy and ALPS training leads to better satisfaction and functional use of the weaker arm in persons with motor impairments more than 6 months after stroke, as compared to robot-assisted therapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks).
Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks). In addition, participants will receive training in active problem solving, analysis of performance and goal setting focused on home action plan activities to assist with carry-over and generalization to every day activities.
MGH Institute of Health Professions
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks
The Fugl-Meyer Assessment (FMA) will examine changes in motor function in the paretic upper extremity (UE) during basic reaching and grasping motions. All items are rated by a 3-point ordinal scale (0=cannot perform; 2=performs fully) with a total possible score of 60 points (reflex items will not be administered). Higher scores indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 6 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 6 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Fugl-Meyer Assessment (FMA) at 10 weeks
The Fugl-Meyer Assessment (FMA) will examine changes in motor function in the paretic upper extremity (UE) during basic reaching and grasping motions. All items are rated by a 3-point ordinal scale (0=cannot perform; 2=performs fully) with a total possible score of 60 points (reflex items will not be administered). Higher scores indicate better performance.
Time frame: Baseline and 10 weeks
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Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 10 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 10 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Modified Ashworth Scale (MAS) at 6 weeks
The Modified Ashworth Scale (MAS) measures velocity-dependent resistance or spasticity during passive range of motion of nine upper limb movements of the weaker arm, using an ordinal scale that ranges from 0 to 4 (0=no increase in muscle tone, 4=affected part rigid in flexion or extension). Lower scores indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Time at 6 weeks
The Wolf Motor Function Test (WMFT) quantifies motor ability in the paretic arm and hand during functionally based upper limb tasks. It consists of 3 parts that are scored separately: timed performance, strength, and an ordinal Functional Ability Scale (FAS). The FAS is scored by the evaluator post testing on a 6-point ordinal scale from 0 (does not attempt with the involved arm) to 5 (arm does participate; movement appears normal) and timed tasks have a maximum allotted time of 120 seconds. Higher FAS scores, greater grip strength (measured in kg) and faster time to accomplish tasks indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 6 weeks
The Wolf Motor Function Test (WMFT) quantifies motor ability in the paretic arm and hand during functionally based upper limb tasks. It consists of 3 parts that are scored separately: timed performance, strength, and an ordinal Functional Ability Scale (FAS). The FAS is scored by the evaluator post testing on a 6-point ordinal scale from 0 (does not attempt with the involved arm) to 5 (arm does participate; movement appears normal) and timed tasks have a maximum allotted time of 120 seconds. Higher FAS scores, greater grip strength (measured in kg) and faster time to accomplish tasks indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 6 weeks
The Wolf Motor Function Test (WMFT) quantifies motor ability in the paretic arm and hand during functionally based upper limb tasks. It consists of 3 parts that are scored separately: timed performance, strength, and an ordinal Functional Ability Scale (FAS). The FAS is scored by the evaluator post testing on a 6-point ordinal scale from 0 (does not attempt with the involved arm) to 5 (arm does participate; movement appears normal) and timed tasks have a maximum allotted time of 120 seconds. Higher FAS scores, greater grip strength (measured in kg) and faster time to accomplish tasks indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Canadian Occupational Performance Measure (COPM) at 6 weeks
The Canadian Occupational Performance Measure (COPM) is a self-report measure to assess upper limb performance during valued daily activities. A Likert scale (Scored from low \[1\] to high \[10\]) is used to rate participant performance of selected functional activities. Higher scores indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Stroke Impact Scale (SIS) at 6 weeks
The Stroke Impact Scale (SIS) is a disease specific 59-item measure divided into 8 domains: strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), mobility, communication, emotion, memory and thinking, and participation/role function. Each item is scored on a 5-point Likert-scale from 1 (unable, extremely difficult) to 5 (not difficult at all). Higher scores for each domain indicate better performance.
Time frame: Baseline and 6 weeks
Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 6 weeks
The Confidence in Arm and Hand Movement (CAHM) Scale is a self-report measure of upper limb functional use during a variety of functional tasks (e.g. cutting food with knife and fork at restaurant, using potholders to remove a hot casserole from the oven). Participants rate how confident/certain they are that they can successfully complete each task (n=20) on a scale from 0 (very uncertain) to 100 (very certain). Item scores are averaged to provide a total confidence score (Max score = 100 points).
Time frame: Baseline and 6 weeks
Change from Baseline Home-based Accelerometry: Wearable Sensors at 6 weeks
The GENEActiv (http://geneactiv.org) wearable sensor is a multi-directional, waterproof sensor used to quantitatively measure upper limb activity during every day living situations. Sensors will be worn on both wrists for 72 hour periods at each assessment point to compare movements of the paretic and intact upper limb during daily activities. A variety of measures (e.g. amount of arm use, ratio of use between both arms) will be derived from the raw data collected from the sensors.
Time frame: Baseline and 6 weeks
Change from Baseline Modified Ashworth Scale (MAS) at 10 weeks
The Modified Ashworth Scale (MAS) measures velocity-dependent resistance or spasticity during passive range of motion of nine upper limb movements of the weaker arm, using an ordinal scale that ranges from 0 to 4 (0=no increase in muscle tone, 4=affected part rigid in flexion or extension). Lower scores indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Time at 10 weeks
The Wolf Motor Function Test (WMFT) quantifies motor ability in the paretic arm and hand during functionally based upper limb tasks. It consists of 3 parts that are scored separately: timed performance, strength, and an ordinal Functional Ability Scale (FAS). The FAS is scored by the evaluator post testing on a 6-point ordinal scale from 0 (does not attempt with the involved arm) to 5 (arm does participate; movement appears normal) and timed tasks have a maximum allotted time of 120 seconds. Higher FAS scores, greater grip strength (measured in kg) and faster time to accomplish tasks indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 10 weeks
The Wolf Motor Function Test (WMFT) quantifies motor ability in the paretic arm and hand during functionally based upper limb tasks. It consists of 3 parts that are scored separately: timed performance, strength, and an ordinal Functional Ability Scale (FAS). The FAS is scored by the evaluator post testing on a 6-point ordinal scale from 0 (does not attempt with the involved arm) to 5 (arm does participate; movement appears normal) and timed tasks have a maximum allotted time of 120 seconds. Higher FAS scores, greater grip strength (measured in kg) and faster time to accomplish tasks indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 10 weeks
The Wolf Motor Function Test (WMFT) quantifies motor ability in the paretic arm and hand during functionally based upper limb tasks. It consists of 3 parts that are scored separately: timed performance, strength, and an ordinal Functional Ability Scale (FAS). The FAS is scored by the evaluator post testing on a 6-point ordinal scale from 0 (does not attempt with the involved arm) to 5 (arm does participate; movement appears normal) and timed tasks have a maximum allotted time of 120 seconds. Higher FAS scores, greater grip strength (measured in kg) and faster time to accomplish tasks indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Canadian Occupational Performance Measure (COPM) at 10 weeks
The Canadian Occupational Performance Measure (COPM) is a self-report measure to assess upper limb performance during valued daily activities. A Likert scale (Scored from low \[1\] to high \[10\]) is used to rate participant performance of selected functional activities. Higher scores indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Stroke Impact Scale (SIS) at 10 weeks
The Stroke Impact Scale (SIS) is a disease specific 59-item measure divided into 8 domains: strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), mobility, communication, emotion, memory and thinking, and participation/role function. Each item is scored on a 5-point Likert-scale from 1 (unable, extremely difficult) to 5 (not difficult at all). Higher scores for each domain indicate better performance.
Time frame: Baseline and 10 weeks
Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 10 weeks
The Confidence in Arm and Hand Movement (CAHM) Scale is a self-report measure of upper limb functional use during a variety of functional tasks (e.g. cutting food with knife and fork at restaurant, using potholders to remove a hot casserole from the oven). Participants rate how confident/certain they are that they can successfully complete each task (n=20) on a scale from 0 (very uncertain) to 100 (very certain). Item scores are averaged to provide a total confidence score (Max score = 100 points).
Time frame: Baseline and 10 weeks
Change from Baseline Home-based Accelerometry: Wearable Sensors at 10 weeks
The GENEActiv (http://geneactiv.org) wearable sensor is a multi-directional, waterproof sensor used to quantitatively measure upper limb activity during every day living situations. Sensors will be worn on both wrists for 72 hour periods at each assessment point to compare movements of the paretic and intact upper limb during daily activities. A variety of measures (e.g. amount of arm use, ratio of use between both arms) will be derived from the raw data collected from the sensors.
Time frame: Baseline and 10 weeks