Trial Outcomes & Findings for Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients (NCT NCT02830893)
NCT ID: NCT02830893
Last Updated: 2020-07-21
Results Overview
We measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to the 3-month follow up evaluation after the end of intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of the upper extremities. For the study, we analyze the total score only. The higher scores indicate a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention
Results posted on
2020-07-21
Participant Flow
Recruitment period from June 2017 to May 2018.
23 study participants were screened and all 23 study participants were randomized.
Participant milestones
| Measure |
The LARA Therapy
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
The LARA Therapy
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
|---|---|---|
|
Overall Study
Relocation to out of the country
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Discharged to SNF, no transportation.
|
0
|
1
|
Baseline Characteristics
We did not include the 4 study participants who dropped out the study to analysis: 1 from the LARA group and 3 from the Standard Therapy group,
Baseline characteristics by cohort
| Measure |
The LARA Therapy
n=12 Participants
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
n=11 Participants
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
20 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=23 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 7.9 • n=11 Participants • We did not include the 4 study participants who dropped out the study to analysis: 1 from the LARA group and 3 from the Standard Therapy group,
|
52.6 years
STANDARD_DEVIATION 9.5 • n=8 Participants • We did not include the 4 study participants who dropped out the study to analysis: 1 from the LARA group and 3 from the Standard Therapy group,
|
52.32 years
STANDARD_DEVIATION 8.37 • n=19 Participants • We did not include the 4 study participants who dropped out the study to analysis: 1 from the LARA group and 3 from the Standard Therapy group,
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
4 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
19 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
11 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
12 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
7 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
11 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
11 participants
n=11 Participants
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of interventionWe measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to the 3-month follow up evaluation after the end of intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of the upper extremities. For the study, we analyze the total score only. The higher scores indicate a better outcome.
Outcome measures
| Measure |
The LARA Therapy
n=11 Participants
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
n=8 Participants
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
|---|---|---|
|
Fugl-Meyer (FM) Motor Assessment of the Upper Extremity
Baseline Evaluation
|
28.5 score on a scale
Standard Deviation 11.6
|
27.4 score on a scale
Standard Deviation 14.7
|
|
Fugl-Meyer (FM) Motor Assessment of the Upper Extremity
Change in Post therapy Evaluation
|
14.2 score on a scale
Standard Deviation 10.8
|
7.9 score on a scale
Standard Deviation 3.8
|
|
Fugl-Meyer (FM) Motor Assessment of the Upper Extremity
Change in 3-month post-intervention
|
18.8 score on a scale
Standard Deviation 12.5
|
14.1 score on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of interventionWe measure the spasticity of the upper extremity at baseline, post-intervention, and at the 3-month 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. For this study, we combine all subscores from each joint to compute a total spasticity score.
Outcome measures
| Measure |
The LARA Therapy
n=11 Participants
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
n=8 Participants
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
|---|---|---|
|
Modified Ashworth Spasticity Scale
3-month Follow Up
|
0.61 score on a scale
Standard Deviation 0.72
|
0.96 score on a scale
Standard Deviation 1.37
|
|
Modified Ashworth Spasticity Scale
Post-Intervention Evaluation
|
0.47 score on a scale
Standard Deviation 0.56
|
0.77 score on a scale
Standard Deviation 0.80
|
|
Modified Ashworth Spasticity Scale
Baseline Evaluation
|
0.64 score on a scale
Standard Deviation 0.64
|
0.56 score on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of interventionWe measure the time one takes to complete a 10-meter walk at baseline evaluation, the post-intervention evaluation, and the 3-month follow up evaluation. Participants are instructed to walk at a distance of 10-meter over a level surface with 2 meters for acceleration and 2 meters for deceleration. Participants are instructed to walk at their comfortable or normal speed over the entire distance. Participants are timed once the first foot passes the acceleration path; the time is stopped once the first foot enters the deceleration path. The lower scores indicate a better outcome.
Outcome measures
| Measure |
The LARA Therapy
n=11 Participants
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
n=8 Participants
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
|---|---|---|
|
Timed 10-meter Walk
Baseline Evaluation
|
18.8 Seconds
Standard Deviation 9.7
|
23.4 Seconds
Standard Deviation 9.1
|
|
Timed 10-meter Walk
Post-Intervention Evaluation
|
15.2 Seconds
Standard Deviation 7.5
|
14.4 Seconds
Standard Deviation 5.0
|
|
Timed 10-meter Walk
3-month Follow Up
|
11.8 Seconds
Standard Deviation 4.4
|
11.8 Seconds
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of interventionWe measured the Box and Blocks Test scores at baseline evaluation, the post-intervention, and at the 3-month 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 are counted as a single block. The higher scores indicate a better outcome.
Outcome measures
| Measure |
The LARA Therapy
n=11 Participants
The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.
LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
The Standard Therapy
n=8 Participants
The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.
Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
|
|---|---|---|
|
Box and Blocks Test
Baseline Evaluation
|
8.5 blocks
Standard Deviation 10.8
|
11.9 blocks
Standard Deviation 13.6
|
|
Box and Blocks Test
Post-Intervention Evaluation
|
23.5 blocks
Standard Deviation 19.2
|
22.1 blocks
Standard Deviation 22.7
|
|
Box and Blocks Test
3-month Follow Up
|
53.4 blocks
Standard Deviation 31.8
|
45.8 blocks
Standard Deviation 44.6
|
Adverse Events
The LARA Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
The Standard Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place