StrokeALPSNCT02747433
Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke
A study testing Robot-Assisted Therapy (RT) and Robot & Task-Oriented Training (RT-TOT) in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively… Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-Assisted Therapy (RT) and Robot & Task-Oriented Training (RT-TOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow \& hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
- Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)12 during 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
- Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
- Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
- 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
- Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
Official title: Infusing Robot-Assisted Therapy With Motor Learning Principles: An Active Learning Program for Stroke
Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. Rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. The purpose of this pilot study is to develop and test a therapy called the "Active Learning Program for Stroke" (ALPS). We are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.
Read the detailed description
Little is known about how individuals learn to utilize robot-trained movements during upper extremity (UE) activities in the home and community and whether specific instruction can enhance motor learning and carry-over.. Systematic reviews of robot-assisted therapy for the paretic UE confirm gains in motor capacity as measured by clinical assessments, but provide little evidence of improved UE performance during daily tasks and occupations. These findings may be attributed to the limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity of practice with little regard for other principles of motor learning and experience-dependent neuroplasticity. These principles, including the salience of training tasks, transfer of acquired skills to similar activities, and active engagement and problem solving, are key to task-oriented training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well integrated into robot-assisted therapy protocols. The transfer of robot-trained movements to UE activities within the home and community needs further exploration before widespread use in rehabilitation practice is expected.
- Conditions
- Stroke
- Being tested
- Robot-Assisted Therapy (RT), Robot & Task-Oriented Training (RT-TOT)
- Keywords
- robot-assisted therapy, task-oriented training, motor learning, cognitive strategy training
- 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)Device
Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Robot training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home \& community.
Robot & Task-Oriented Training (RT-TOT)Device
Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training will be delivered for remaining 30 mins of each treatment session. Robot and task oriented training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home \& community.
| Study group | Role | What they receive |
|---|---|---|
| ALPS + Robot-Assisted Therapy (RT) | Active comparator | Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training Receives: Device: Robot-Assisted Therapy (RT) |
| ALPS + Robot + Task-Oriented Training (RT-TOT) | Active comparator | Armeo and Amadeo robot-assisted intensive upper extremity therapy 30 mins, 3x week for 6 weeks plus ALPS training. Task oriented training will be provided for remaining 30 min of each treatment session Receives: Device: Robot & Task-Oriented Training (RT-TOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest
The FMA will examine changes in motor function, pain and sensation in the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The FMA upper extremity subtest contains 33 items, scored as 0= unable, 1=partial ability, 2= faultless with a total possible score of 66 points. Change was calculated as the value at the 1 month follow-up assessment minus the value at baseline to reflect retention of motor function following intervention.
Measured: Baseline and 1-month follow-up
Change From Baseline in Wolf Motor Function Test (WMFT)
The WMFT examined changes in ability to complete timed, functionally-based activities with the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The task rate was calculated as the average # of times that each test item could be completed within 1 minute. Here we report the change in task rate scores between admission and 1 month follow-up assessments to reflect retention of motor function following intervention. A higher number indicates improved task completion.
Measured: Baseline and 1-month follow-up
Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale
The CAHM is a self-report assessment in which participants are asked to rate their confidence (0-100%) in successfully using their paretic UE for a variety of everyday activities. Change in confidence ratings between baseline, post-intervention and 1-month follow up assessments were examined. A higher score indicates greater confidence. We report change scores between admission and 1 month follow up assessments to reflect retention of scores following intervention.
Measured: Baseline and 1-month follow-up
Secondary outcomes (7)
Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale
The MAL has been widely used in stroke rehabilitation studies to measure self-reported amount and quality of paretic arm use during daily activities. Participant's self-reported amount of use (AOU) and how well the task was performed (HW) are rated on a scale from 0=not used at all to 5=as much or as well as before the stroke. Higher scores indicate greater perceived motor function in the paretic arm \& hand.
We report change scores in amount of use (AOU) between admission and 1 month follow up assessments to reflect retention of motor function following intervention..
Measured: Baseline and 1-month follow-up
Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale
The MAL has been widely used in stroke rehabilitation studies to measure self-reported amount and quality of paretic arm use during daily activities. Participant's self-reported amount of use (AOU) and how well the task was performed (HW) are rated on a scale from 0=not used at all to 5=as much or as well as before the stroke. Higher scores indicate greater perceived motor function in the paretic arm \& hand.
We report change scores in how well the function was performed between admission and 1 month follow up assessments to reflect retention of motor function following intervention..
Measured: Baseline and 1-month follow-up
Change From Baseline on Modified Ashworth Scale (MAS)
The MAS examined changes in muscle tone in the paretic UE . Scores range from 0=no increase in muscle tone to 4=affected part(s) rigid in flexion or extension. Tested muscle groups include shoulder internal rotators, elbow flexors/extensors, supinators, pronators, wrist flexors/extensors, finger flexors/extensors. Lower scores indicate better motor function. We present the change scores between admission and 1 month follow up assessments to reflect retention of motor function following intervention. .
Measured: Baseline and 1-month follow-up
Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain
The SIS measured changes in activity and participation due to stroke. The SIS assesses eight domains including strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory \& thinking, and participation/role function. A transformed score for each domain is calculated from its raw score and represented by a 100 point scale, with higher scores representing better performance. We report the change in transformed scores for the hand function domain, between admission and 1 month follow up assessments to reflect retention of motor function following intervention.
Measured: Baseline and 1-month follow-up
Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery
The SIS measures changes in activity and participation due to stroke. The SIS assesses eight domains including strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory \& thinking, and participation/role function. A transformed score for each domain is calculated from its raw score and represented by a 100 point scale, with higher scores representing better performance. We report the participants' rating of stroke recovery (how much the participant feels that he/she has recovered from stroke with 0=no recovery, 100=full recovery), between admission and 1 month follow up assessments to reflect retention of motor function following intervention.
Measured: Baseline and 1-month follow-up
Change From Baseline in Movement Time During Reach-to-Target Task
Participants were asked to reach forward from a designated starting position toward a panel with 12 numbered targets positioned in a clockwise-fashion 20 cm from from its center. The center of the target was aligned with the acromion of the paretic arm and reflective markers were attached to locations on the trunk and paretic arm to allow recording of kinematic data via 3-D motion capture (Vicon Motion Systems Ltd. UK) for off-line analysis. Data from reaching movements to all targets were combined for analysis. We report the median values for Movement Time (sec) for the entire sample at the time of a discharge assessment immediately following the 6-week intervention.
Measured: Baseline and immediately after 6-week intervention
Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task
Participants were asked to reach forward from a designated starting position toward a panel with 12 numbered targets positioned in a clockwise-fashion 20 cm from from its center. The center of the target was aligned with the acromion of the paretic arm and reflective markers were attached to locations on the trunk and paretic arm to allow recording of kinematic data via 3-D motion capture (Vicon Motion Systems Ltd. UK) for off-line analysis. Data from reaching movements to all targets were combined for analysis. We report the median values for Log Normalized Jerk, a measure of movement smoothness during reach, for the entire sample at the time of a discharge assessment immediately following the 6-week intervention.
Measured: Baseline and immediately after 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion10 Nov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Fasoli, ScD OTR/L, Spaulding Rehabilitation Hospital
- Investigators
- Susan E Fasoli, ScD, Principal investigator, MGH Institute of Health Professions & Spaulding Rehabilitation HospitalPaolo Bonato, PhD, Study chair, Spaulding Rehabilitation Hospital & Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747433
- Sponsor's protocol ID
- 2015P002107
- Acronym
- ALPS
- Status last verified
- May 2022
- First submitted
- 18 Apr 2016
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Adans-Dester C, Fasoli SE, Fabara E, Menard N, Fox AB, Severini G, Bonato P. Can kinematic parameters of 3D reach-to-target movements be used as a proxy for clinical outcome measures in chronic stroke rehabilitation? An exploratory study. J Neuroeng Rehabil. 2020 Aug 8;17(1):106. doi: 10.1186/s12984-020-00730-1.
PubMed 32771020
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusing Robot-Assisted Therapy With Motor Learning Principles: An Active Learning Program for Stroke
- ClinicalTrials.gov ID
- NCT02747433
- Acronym / sponsor ID
- ALPS / 2015P002107
- Conditions
- Stroke
- Keywords
- robot-assisted therapy, task-oriented training, motor learning, cognitive strategy training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. Rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. The purpose of this pilot study is to develop and test a therapy called the "Active Learning Program for Stroke" (ALPS). We are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.
Detailed description
Little is known about how individuals learn to utilize robot-trained movements during upper extremity (UE) activities in the home and community and whether specific instruction can enhance motor learning and carry-over.. Systematic reviews of robot-assisted therapy for the paretic UE confirm gains in motor capacity as measured by clinical assessments, but provide little evidence of improved UE performance during daily tasks and occupations. These findings may be attributed to the limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity of practice with little regard for other principles of motor learning and experience-dependent neuroplasticity. These principles, including the salience of training tasks, transfer of acquired skills to similar activities, and active engagement and problem solving, are key to task-oriented training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well integrated into robot-assisted therapy protocols. The transfer of robot-trained movements to UE activities within the home and community needs further exploration before widespread use in rehabilitation practice is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALPS + Robot-Assisted Therapy (RT) | Active comparator | Device: Robot-Assisted Therapy (RT)Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training |
| ALPS + Robot + Task-Oriented Training (RT-TOT) | Active comparator | Device: Robot & Task-Oriented Training (RT-TOT)Armeo and Amadeo robot-assisted intensive upper extremity therapy 30 mins, 3x week for 6 weeks plus ALPS training. Task oriented training will be provided for remaining 30 min of each treatment session |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow \& hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
- Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)12 during initial evaluation visit
Key exclusion criteria (6 listed)
- No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy
- Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
- Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
- 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 repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Robot training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home \& community. | Device | ALPS + Robot-Assisted Therapy (RT) |
| Robot & Task-Oriented Training (RT-TOT)Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training will be delivered for remaining 30 mins of each treatment session. Robot and task oriented training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home \& community. | Device | ALPS + Robot + Task-Oriented Training (RT-TOT) |
Primary outcome
Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest
Time frame: Baseline and 1-month follow-up
The FMA will examine changes in motor function, pain and sensation in the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The FMA upper extremity subtest contains 33 items, scored as 0= unable, 1=partial ability, 2= faultless with a total possible score of 66 points. Change was calculated as the value at the 1 month follow-up assessment minus the value at baseline to reflect retention of motor function following intervention.
Change From Baseline in Wolf Motor Function Test (WMFT)
Time frame: Baseline and 1-month follow-up
The WMFT examined changes in ability to complete timed, functionally-based activities with the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The task rate was calculated as the average # of times that each test item could be completed within 1 minute. Here we report the change in task rate scores between admission and 1 month follow-up assessments to reflect retention of motor function following intervention. A higher number indicates improved task completion.
Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale
Time frame: Baseline and 1-month follow-up
The CAHM is a self-report assessment in which participants are asked to rate their confidence (0-100%) in successfully using their paretic UE for a variety of everyday activities. Change in confidence ratings between baseline, post-intervention and 1-month follow up assessments were examined. A higher score indicates greater confidence. We report change scores between admission and 1 month follow up assessments to reflect retention of scores following intervention.
7 secondary outcomes
Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale
Time frame: Baseline and 1-month follow-up
Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale
Time frame: Baseline and 1-month follow-up
Change From Baseline on Modified Ashworth Scale (MAS)
Time frame: Baseline and 1-month follow-up
Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain
Time frame: Baseline and 1-month follow-up
Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery
Time frame: Baseline and 1-month follow-up
Change From Baseline in Movement Time During Reach-to-Target Task
Time frame: Baseline and immediately after 6-week intervention
Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task
Time frame: Baseline and immediately after 6-week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32771020Adans-Dester C, Fasoli SE, Fabara E, Menard N, Fox AB, Severini G, Bonato P. Can kinematic parameters of 3D reach-to-target movements be used as a proxy for clinical outcome measures in chronic stroke rehabilitation? An exploratory study. J Neuroeng Rehabil. 2020 Aug 8;17(1):106. doi: 10.1186/s12984-020-00730-1.
- 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.
Susan E Fasoli, ScD principal investigator
MGH Institute of Health Professions & Spaulding Rehabilitation Hospital
Paolo Bonato, PhD study chair
Spaulding Rehabilitation Hospital & Harvard Medical School
1 site 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 & Task-Oriented Training (RT-TOT) in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest (time frame: Baseline and 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747433, which also lists 1 linked publication.
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 31 May 2022.