Trial Outcomes & Findings for Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke (NCT NCT02747433)
NCT ID: NCT02747433
Last Updated: 2022-05-31
Results Overview
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.
COMPLETED
NA
11 participants
Baseline and 1-month follow-up
2022-05-31
Participant Flow
Of the eleven individuals enrolled, one did not meet inclusion criteria and ten were randomized to treatment.
Participant milestones
| Measure |
ALPS + Robot-Assisted Therapy (RT)
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke
Baseline characteristics by cohort
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 19.8 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 19.5 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 19.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Fugl-Meyer Assessment-Upper Extremity
|
30.4 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 12.4 • n=7 Participants
|
32.2 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest
|
11.0 score on a scale
Interval 9.0 to 14.0
|
2.0 score on a scale
Interval -1.0 to 8.0
|
8.5 score on a scale
Interval -1.0 to 14.0
|
PRIMARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Wolf Motor Function Test (WMFT)
|
10.22 units on a scale
Interval -1.18 to 10.77
|
3.07 units on a scale
Interval -0.52 to 8.47
|
6.98 units on a scale
Interval -1.18 to 10.77
|
PRIMARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale
|
8.00 score on a scale
Interval -14.0 to 21.75
|
9.50 score on a scale
Interval 4.25 to 49.0
|
8.75 score on a scale
Interval -14.0 to 49.0
|
SECONDARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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..
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale
|
0.89 units on a scale
Interval 0.12 to 1.75
|
0.52 units on a scale
Interval 0.15 to 0.83
|
0.59 units on a scale
Interval 0.12 to 1.75
|
SECONDARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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..
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale
|
1.00 units on a scale
Interval 0.06 to 1.55
|
0.71 units on a scale
Interval 0.27 to 0.93
|
0.81 units on a scale
Interval 0.06 to 1.55
|
SECONDARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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. .
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline on Modified Ashworth Scale (MAS)
|
0.00 units on a scale
Interval -0.22 to 0.22
|
0.22 units on a scale
Interval -0.22 to 0.39
|
0.03 units on a scale
Interval -0.22 to 0.39
|
SECONDARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain
|
8.00 score on a scale
Interval 0.0 to 24.0
|
4.00 score on a scale
Interval 4.0 to 20.0
|
4.00 score on a scale
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Baseline and 1-month follow-upPopulation: Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=5 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
n=5 Participants
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
n=10 Participants
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery
|
20.00 score on a scale
Interval -20.0 to 25.0
|
5.00 score on a scale
Interval -6.0 to 10.0
|
10.00 score on a scale
Interval -20.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline and immediately after 6-week interventionPopulation: Because the primary aim of this pilot was to explore the combined effects of the Active Learning Program for Stroke (ALPS ) and robot-assisted therapy/task oriented training, a decision was made a priori that this data would be collected and analyzed in a pooled manner for this exploratory endpoint.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=10 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Movement Time During Reach-to-Target Task
Baseline
|
2.37 seconds
Interval 1.95 to 2.86
|
—
|
—
|
|
Change From Baseline in Movement Time During Reach-to-Target Task
Discharge
|
2.17 seconds
Interval 1.94 to 2.51
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and immediately after 6-week interventionPopulation: Because the primary aim of this pilot was to explore the combined effects of the Active Learning Program for Stroke (ALPS ) and robot-assisted therapy/task oriented training, a decision was made a priori that this data would be collected and analyzed in a pooled manner for this exploratory endpoint.
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.
Outcome measures
| Measure |
ALPS + Robot-Assisted Therapy (RT)
n=10 Participants
Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home \& community.
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 (1 hr sessions, 3x week for 3 weeks).
|
ALPS + Robot + Task-Oriented Training (RT-TOT)
Robot and task-oriented training was combined with the Active Learning Program for Stroke (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): 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 was delivered for remaining 30 mins of each treatment session.
|
ALPS + RT + RT-TOT
Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home \& community.
The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task
Baseline
|
-18.89 dimensionless
Interval -19.66 to -18.25
|
—
|
—
|
|
Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task
Discharge
|
-18.14 dimensionless
Interval -19.21 to -17.97
|
—
|
—
|
Adverse Events
Robot-Assisted Therapy (RT)
Robot & Task-Oriented Training (RT-TOT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan Fasoli, ScD OTR/L, Associate Professor
MGH Institute of Health Professions
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place