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Rehabilitation Robotics, Cognitive Skills Training and Function

Primary Purpose

Stroke, Cerebrovascular Accident

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robot-Assisted Therapy (RT)
Robot + Active Learning Program(RT-ALPS)
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Upper limb function, Arm and hand weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with unilateral stroke more than 6 months prior to study enrollment.
  • Stroke type will include both ischemic and hemorrhagic stroke.
  • Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60)
  • Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)during the initial evaluation visit

Exclusion Criteria:

  • No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the Fugl-Meyer Assessment (FMA) [13]
  • Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale [15];
  • Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test [16]
  • Aphasia sufficient to limit comprehension and completion of the treatment protocol
  • Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
  • Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study
  • Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE

Sites / Locations

  • MGH Institute of Health ProfessionsRecruiting
  • Spaulding Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Robot-Assisted Therapy (RT)

Robot + Active Learning Program(RT-ALPS)

Arm Description

Armeo & Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks.

Armeo & Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks plus training in active problem solving, analysis of performance, and goal-setting focused on the transfer of acquired motor skills to daily activities in the home and community.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
July 16, 2018
Last Updated
May 26, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03599544
Brief Title
Rehabilitation Robotics, Cognitive Skills Training and Function
Official Title
A Paradigm Sift: Rehabilitation Robotics, Cognitive Skills Training and Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
American Occupational Therapy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident
Keywords
Upper limb function, Arm and hand weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Evaluator(s) will be blinded to assigned study group and intervention.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot-Assisted Therapy (RT)
Arm Type
Active Comparator
Arm Description
Armeo & Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks.
Arm Title
Robot + Active Learning Program(RT-ALPS)
Arm Type
Experimental
Arm Description
Armeo & Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks plus training in active problem solving, analysis of performance, and goal-setting focused on the transfer of acquired motor skills to daily activities in the home and community.
Intervention Type
Behavioral
Intervention Name(s)
Robot-Assisted Therapy (RT)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Robot + Active Learning Program(RT-ALPS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks
Description
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
Title
Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 6 weeks
Description
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
Title
Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 6 weeks
Description
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
Title
Change from Baseline Fugl-Meyer Assessment (FMA) at 10 weeks
Description
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
Title
Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 10 weeks
Description
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
Title
Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 10 weeks
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline Modified Ashworth Scale (MAS) at 6 weeks
Description
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
Title
Change from Baseline Wolf Motor Function Test (WMFT) Time at 6 weeks
Description
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
Title
Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 6 weeks
Description
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
Title
Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 6 weeks
Description
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
Title
Change from Baseline Canadian Occupational Performance Measure (COPM) at 6 weeks
Description
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
Title
Change from Baseline Stroke Impact Scale (SIS) at 6 weeks
Description
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
Title
Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 6 weeks
Description
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
Title
Change from Baseline Home-based Accelerometry: Wearable Sensors at 6 weeks
Description
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
Title
Change from Baseline Modified Ashworth Scale (MAS) at 10 weeks
Description
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
Title
Change from Baseline Wolf Motor Function Test (WMFT) Time at 10 weeks
Description
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
Title
Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 10 weeks
Description
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
Title
Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 10 weeks
Description
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
Title
Change from Baseline Canadian Occupational Performance Measure (COPM) at 10 weeks
Description
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
Title
Change from Baseline Stroke Impact Scale (SIS) at 10 weeks
Description
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
Title
Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 10 weeks
Description
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
Title
Change from Baseline Home-based Accelerometry: Wearable Sensors at 10 weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with unilateral stroke more than 6 months prior to study enrollment. Stroke type will include both ischemic and hemorrhagic stroke. Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60) Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)during the initial evaluation visit Exclusion Criteria: No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the Fugl-Meyer Assessment (FMA) [13] Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale [15]; Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test [16] Aphasia sufficient to limit comprehension and completion of the treatment protocol Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan E Fasoli, ScD OTR/L
Phone
617-643-4777
Email
sfasoli@mghihp.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Adans-Dester
Phone
617-952-6321
Email
cadans-dester@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
MGH Institute of Health Professions
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan E Fasoli, ScD
Phone
617-643-4777
Email
sfasoli@mghihp.edu
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan E. Fasoli, ScD
Phone
617-643-4777
Email
sfasoli@mghihp.edu
First Name & Middle Initial & Last Name & Degree
Catherine Adans-Dester
Phone
617-952-6321
Email
cadans-dester@partners.org
First Name & Middle Initial & Last Name & Degree
Susan E. Fasoli, ScD
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Rehabilitation Robotics, Cognitive Skills Training and Function

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