An interventional study of Robot-Assisted Therapy (RT) and Robot & Task-Oriented Training (RT-TOT) in Stroke, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
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Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training
Device: Robot-Assisted Therapy (RT)
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
Device: Robot & Task-Oriented Training (RT-TOT)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 1-month follow-up
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..
Time frame: 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..
Time frame: 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. .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and immediately after 6-week intervention
| Milestone | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
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.
| score on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest | 11.0 (9.0 to 14.0) | 2.0 (-1.0 to 8.0) | 8.5 (-1.0 to 14.0) |
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.
| units on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline in Wolf Motor Function Test (WMFT) | 10.22 (-1.18 to 10.77) | 3.07 (-0.52 to 8.47) | 6.98 (-1.18 to 10.77) |
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.
| score on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale | 8.00 (-14.00 to 21.75) | 9.50 (4.25 to 49.00) | 8.75 (-14.00 to 49.00) |
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..
| units on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale | 0.89 (0.12 to 1.75) | 0.52 (0.15 to 0.83) | 0.59 (0.12 to 1.75) |
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..
| units on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot & Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale | 1.00 (0.06 to 1.55) | 0.71 (0.27 to 0.93) | 0.81 (0.06 to 1.55) |
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. .
| units on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot & Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline on Modified Ashworth Scale (MAS) | 0.00 (-0.22 to 0.22) | 0.22 (-0.22 to 0.39) | 0.03 (-0.22 to 0.39) |
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.
| score on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot & Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain | 8.00 (0.00 to 24.00) | 4.00 (4.00 to 20.00) | 4.00 (0.00 to 24.00) |
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.
| score on a scale | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot & Task-Oriented Training (RT-TOT) | ALPS + RT + RT-TOT |
|---|---|---|---|
| Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery | 20.00 (-20.000 to 25.00) | 5.00 (-6.00 to 10.00) | 10.00 (-20.00 to 25.00) |
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.
| seconds | ALPS + RT + RT-TOT |
|---|---|
| Baseline | 2.37 (1.95 to 2.86) |
| Discharge | 2.17 (1.94 to 2.51) |
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.
| dimensionless | ALPS + RT + RT-TOT |
|---|---|
| Baseline | -18.89 (-19.66 to -18.25) |
| Discharge | -18.14 (-19.21 to -17.97) |
Collected over Adverse event data for participants was collected during a 12 week period ranging from baseline to one-month follow-up assessments.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robot-Assisted Therapy (RT) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Robot & Task-Oriented Training (RT-TOT) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | Total |
|---|---|---|---|
| Mean | 59.9 ± 19.8 | 46.5 ± 19.5 | 53.2 ± 19.8 |
| Sex: Female, Male(Participants) | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 4 | 2 | 6 |
| Ethnicity (NIH/OMB)(Participants) | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
| Fugl-Meyer Assessment-Upper Extremity(units on a scale) | ALPS + Robot-Assisted Therapy (RT) | ALPS + Robot + Task-Oriented Training (RT-TOT) | Total |
|---|---|---|---|
| Mean | 30.4 ± 6.7 | 34.0 ± 12.4 | 32.2 ± 9.6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2016 to primary completion in Nov 2018, 28 months.
Results were first posted in Apr 2020, 1 year 4 months after primary completion.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 28 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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