- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747433
Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke (ALPS)
Infusing Robot-Assisted Therapy With Motor Learning Principles: An Active Learning Program for Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02129
- Spaulding Rehabilitation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ALPS + Robot-Assisted Therapy (RT)
Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training
|
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.
|
Active Comparator: ALPS + 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 1-month follow-up
|
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.
|
Baseline and 1-month follow-up
|
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.
|
Baseline and 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale
Time Frame: Baseline and 1-month follow-up
|
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.. |
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
|
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.. |
Baseline and 1-month follow-up
|
Change From Baseline on Modified Ashworth Scale (MAS)
Time Frame: Baseline and 1-month follow-up
|
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. .
|
Baseline and 1-month follow-up
|
Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain
Time Frame: Baseline and 1-month follow-up
|
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.
|
Baseline and 1-month follow-up
|
Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery
Time Frame: Baseline and 1-month follow-up
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline and immediately after 6-week intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan E Fasoli, ScD, MGH Institute of Health Professions & Spaulding Rehabilitation Hospital
- Study Chair: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital & Harvard Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P002107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Robot-Assisted Therapy (RT)
-
Spaulding Rehabilitation HospitalAmerican Occupational Therapy FoundationTerminatedStroke | Cerebrovascular AccidentUnited States
-
National Taiwan University HospitalUnknownCerebrovascular AccidentTaiwan
-
National University Hospital, SingaporeNational University, Singapore; Agency for Science, Technology and ResearchCompleted
-
Chang Gung Memorial HospitalCompleted
-
National Taiwan University HospitalUnknown
-
Afyonkarahisar Health Sciences UniversityCompleted
-
US Department of Veterans AffairsCompleted
-
I.R.C.C.S. Fondazione Santa LuciaUniversità degli studi di Roma Foro ItalicoRecruitingStroke | Stroke, IschemicItaly
-
Afyonkarahisar Health Sciences UniversityCompletedStroke | Robot Assisted Therapy | Robotic RehabilitationTurkey
-
Yonsei UniversityRecruitingSubacute StrokeKorea, Republic of