StrokeNCT03599544
Rehabilitation Robotics, Cognitive Skills Training and Function
A study testing Robot-Assisted Therapy (RT) and Robot + Active Learning Program(RT-ALPS) in people with Stroke and Cerebrovascular Accident, run by Spaulding Rehabilitation Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- Robot-Assisted Therapy (RT) and Robot + Active Learning Program(RT-ALPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2019to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MGH Institute of Health Professions
Boston, Massachusetts, 02129
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
Official title: A Paradigm Sift: Rehabilitation Robotics, Cognitive Skills Training and Function
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.
Read the 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.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- Robot-Assisted Therapy (RT), Robot + Active Learning Program(RT-ALPS)
- Keywords
- Upper limb function, Arm and hand weakness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Therapy (RT)Behavioural
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).
Robot + Active Learning Program(RT-ALPS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Therapy (RT) | Active comparator | Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks. Receives: Behavioral: Robot-Assisted Therapy (RT) |
| Robot + Active Learning Program(RT-ALPS) | Experimental | 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. Receives: Behavioral: Robot + Active Learning Program(RT-ALPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 10 weeks
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.
Measured: 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.
Measured: Baseline and 10 weeks
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start6 Jun 2019
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: Study was halted prematurely and will not resume due to loss of funding and access to rehabilitation exoskeleton robot (ArmeoSpring), prohibiting completion of project as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Susan Fasoli, ScD OTR/L, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Study chair, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599544
- Sponsor's protocol ID
- 2018P001182
- Other IDs
- AOTFIRG18FASOLI
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2018
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Paradigm Sift: Rehabilitation Robotics, Cognitive Skills Training and Function
- ClinicalTrials.gov ID
- NCT03599544
- Acronym / sponsor ID
- 2018P001182
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- Upper limb function, Arm and hand weakness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted prematurely and will not resume due to loss of funding and access to rehabilitation exoskeleton robot (ArmeoSpring), prohibiting completion of project as planned.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Therapy (RT) | Active comparator | Behavioral: Robot-Assisted Therapy (RT)Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks. |
| Robot + Active Learning Program(RT-ALPS) | Experimental | Behavioral: Robot + Active Learning Program(RT-ALPS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted Therapy (RT)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). | Behavioural | Robot-Assisted Therapy (RT) |
| Robot + Active Learning Program(RT-ALPS)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. | Behavioural | Robot + Active Learning Program(RT-ALPS) |
Primary outcome
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Baseline and 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.
16 secondary outcomes
Change from Baseline Modified Ashworth Scale (MAS) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Time at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Canadian Occupational Performance Measure (COPM) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Stroke Impact Scale (SIS) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Home-based Accelerometry: Wearable Sensors at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Modified Ashworth Scale (MAS) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Time at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Canadian Occupational Performance Measure (COPM) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Stroke Impact Scale (SIS) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline Home-based Accelerometry: Wearable Sensors at 10 weeks
Time frame: Baseline and 10 weeks
Results and safety
The study was stopped early (reason given: Study was halted prematurely and will not resume due to loss of funding and access to rehabilitation exoskeleton robot (ArmeoSpring), prohibiting completion of project as planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bonato, PhD study chair
Spaulding Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Therapy (RT) and Robot + Active Learning Program(RT-ALPS) in people with Stroke and Cerebrovascular Accident, run by Spaulding Rehabilitation Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was halted prematurely and will not resume due to loss of funding and access to rehabilitation exoskeleton robot (ArmeoSpring), prohibiting completion of project as planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks (time frame: Baseline and 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.