Trial Outcomes & Findings for Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke (NCT NCT05880940)
NCT ID: NCT05880940
Last Updated: 2026-02-27
Results Overview
The investigators measure the change of the Fugl-Meyer Arm Motor Assessment scores from the baseline evaluation to the 3-month post stroke follow up evaluation. Fugl-Meyer Arm Motor Assessment is a 66-point scale measuring the movement pattern of the upper extremities. The minimum score is zero and the maximum score is 66. The higher scores indicate a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (At discharge: assessed up to 3 weeks post baseline), and 3-month post-stroke evaluation (Follow up occurred at Month 3 after Baseline)
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Boost - Moveable Wheelchair Arm Rest
participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Boost - Moveable Wheelchair Arm Rest
participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
|---|---|---|
|
Overall Study
1 participant suffered from another stroke.
|
1
|
0
|
|
Overall Study
Cognitive impairement
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
Baseline characteristics by cohort
| Measure |
Boost - Moveable Wheelchair Arm Rest
n=19 Participants
Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
n=16 Participants
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
0 Participants
n=14 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
0 Participants
n=31 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=17 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
12 Participants
n=14 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
22 Participants
n=31 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
|
Age, Categorical
>=65 years
|
7 Participants
n=17 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
2 Participants
n=14 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
9 Participants
n=31 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 15.3 • n=19 Participants
|
59.5 years
STANDARD_DEVIATION 12.3 • n=16 Participants
|
59.46 years
STANDARD_DEVIATION 14.07 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=17 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
4 Participants
n=14 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
14 Participants
n=31 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
|
Sex: Female, Male
Male
|
7 Participants
n=17 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
10 Participants
n=14 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
17 Participants
n=31 Participants • Two participants were excluded from final analysis due to one participant did not complete the intervention (cognitive impairment), and the other participant discontinued intervention (suffered from a second stroke)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=19 Participants
|
9 Participants
n=16 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=19 Participants
|
5 Participants
n=16 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
2 Participants
n=16 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
16 participants
n=16 Participants
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (At discharge: assessed up to 3 weeks post baseline), and 3-month post-stroke evaluation (Follow up occurred at Month 3 after Baseline)Population: The change in FMAMA scores from Baseline (BL) to Post-Intervention (PI) and from 3-month post-stroke follow up (FU) to Baseline (BL).
The investigators measure the change of the Fugl-Meyer Arm Motor Assessment scores from the baseline evaluation to the 3-month post stroke follow up evaluation. Fugl-Meyer Arm Motor Assessment is a 66-point scale measuring the movement pattern of the upper extremities. The minimum score is zero and the maximum score is 66. The higher scores indicate a better outcome.
Outcome measures
| Measure |
Boost - Moveable Wheelchair Arm Rest
n=17 Participants
Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
n=14 Participants
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
|---|---|---|
|
Fugl-Meyer Arm Motor Assessment Score (FMAMA)
Change in score (PI - BL)
|
11.8 score on a scale
Standard Deviation 6.8
|
6.9 score on a scale
Standard Deviation 6.9
|
|
Fugl-Meyer Arm Motor Assessment Score (FMAMA)
Change in score (FU - BL)
|
18.6 score on a scale
Standard Deviation 11.3
|
19.2 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (At discharge: assessed up to 3 weeks post baseline), and 3-month post-stroke evaluation (Follow up occurred at Month 3 after Baseline)Population: We compared the Modified Ashworth Spasticity Scale (MASS) of the elbow and wrist between groups at Baseline (BL), Post-intervention (PI), and 3-month post-stroke follow up(FU).
The investigators measure the spasticity of the upper extremity at baseline, post-intervention, and at the 3-month post stroke follow up evaluation. Spasticity is described as the resistance to passive movement. Participants are asked to relax and evaluators assess muscle resistance to passive movement at one joint at a time: Shoulder, elbow, wrist, and fingers. The evaluator will then grade the resistance on a 6-point scale for each joint. Higher scores indicate more rigid movement or more muscle tone resistance. The minimum score is zero and the maximum score is 4.
Outcome measures
| Measure |
Boost - Moveable Wheelchair Arm Rest
n=17 Participants
Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
n=14 Participants
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
|---|---|---|
|
Modified Ashworth Spasticity Scale (MASS)
MASS of elbow at BL
|
1.7 score on a scale
Standard Deviation 1.1
|
1.7 score on a scale
Standard Deviation 1.1
|
|
Modified Ashworth Spasticity Scale (MASS)
MASS of elbow at PI
|
1.7 score on a scale
Standard Deviation 1.3
|
1.5 score on a scale
Standard Deviation 1.1
|
|
Modified Ashworth Spasticity Scale (MASS)
MASS of elbow at FU
|
1.9 score on a scale
Standard Deviation 1.5
|
1.9 score on a scale
Standard Deviation 1.1
|
|
Modified Ashworth Spasticity Scale (MASS)
MASS of wrist at BL
|
0.9 score on a scale
Standard Deviation 0.9
|
1.0 score on a scale
Standard Deviation 1.1
|
|
Modified Ashworth Spasticity Scale (MASS)
MASS of wrist at PI
|
1.3 score on a scale
Standard Deviation 1.1
|
1.0 score on a scale
Standard Deviation 0.8
|
|
Modified Ashworth Spasticity Scale (MASS)
MASs of wrist at FU
|
1.5 score on a scale
Standard Deviation 1.1
|
1.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (At discharge: assessed up to 3 weeks post baseline), and 3-month post-stroke evaluation (Follow up occurred at Month 3 after Baseline)Population: We compared the Box and Block Test (BBT) scores between groups at Baseline (BL), Post-Intervention (PI), and 3-month post-stroke follow up (FU)
The investigators measure the Box and Blocks Test scores at baseline, post-intervention, and at 3-month post stroke follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
Outcome measures
| Measure |
Boost - Moveable Wheelchair Arm Rest
n=17 Participants
Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
n=14 Participants
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
|---|---|---|
|
Box and Blocks Test
BBT at PI
|
8.2 Blocks
Standard Deviation 9.4
|
6.7 Blocks
Standard Deviation 9.6
|
|
Box and Blocks Test
BBT at FU
|
16.0 Blocks
Standard Deviation 14.3
|
22.5 Blocks
Standard Deviation 14.9
|
|
Box and Blocks Test
BBT at BL
|
3.2 Blocks
Standard Deviation 5.9
|
1.9 Blocks
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (At discharge: assessed up to 3 weeks post baseline), and 3-month post-stroke evaluation (Follow up occurred at Month 3 after Baseline)Population: We compared the shoulder subluxation distance, average of 3 trials, between groups at Baseline (BL), Post-intervention (PI), and 3-month post-stroke follow up (FU)
The investigators measure the shoulder subluxation distance at baseline, post-intervention, and at 3-month post stroke follow up evaluation. Participants are asked to be seated in a upright chair and relax their affected upper extremity. The evaluator measures the distance, in centimeter, between the inferior aspect of the acromion and the superior aspect of the humeral head. The lower scores indicate a better outcome.
Outcome measures
| Measure |
Boost - Moveable Wheelchair Arm Rest
n=17 Participants
Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
|
Electronic Arm Exercises
n=14 Participants
Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.
|
|---|---|---|
|
Shoulder Subluxation Distance
Shoulder subluxation distance at BL
|
0.6 centimeter
Standard Deviation 0.7
|
0.6 centimeter
Standard Deviation 0.9
|
|
Shoulder Subluxation Distance
Shoulder subluxation distance at PT
|
0.4 centimeter
Standard Deviation 0.8
|
0.2 centimeter
Standard Deviation 0.4
|
|
Shoulder Subluxation Distance
Shoulder subluxation distance at FU
|
0.5 centimeter
Standard Deviation 0.8
|
0.3 centimeter
Standard Deviation 0.6
|
Adverse Events
Boost - Moveable Wheelchair Arm Rest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Electronic Arm Exercises
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
An Do, M.D., Associate Professor
University of California Irvine
Phone: (714) 456 - 2332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place