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This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated Resonance Assistance. LARA facilitates patients in performing a high amount of practice using their moderate to severely impaired upper extremity after stroke.
Investigators will recruit 44 subjects with subacute strokes to participate in the study through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA therapy group will use LARA to propel themselves to therapy appointments in the unit and to play video games with the affected upper extremity for 30 mins / day. The standard therapy group will use a standard wheelchair to propel themselves using their unaffected upper and lower extremities. They will be asked to perform a matched duration of standard arm exercises for 30 mins/ day. This program of standard arm exercises was developed by an OT at the Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported exercises.
This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge from the acute rehabilitation unit if sooner, and a 3-month follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The LARA Therapy | Experimental | 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. |
|
| The Standard Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LARA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer (FM) Motor Assessment of the Upper Extremity | 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. | Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Spasticity Scale | We 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Cramer, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34027703 | Derived | Smith BW, Lobo-Prat J, Zondervan DK, Lew C, Chan V, Chou C, Toledo S, Reinkensmeyer DJ, Shaw S, Cramer SC. Using a bimanual lever-driven wheelchair for arm movement practice early after stroke: A pilot, randomized, controlled, single-blind trial. Clin Rehabil. 2021 Nov;35(11):1577-1589. doi: 10.1177/02692155211014362. Epub 2021 May 24. |
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23 study participants were screened and all 23 study participants were randomized.
Recruitment period from June 2017 to May 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer (FM) Motor Assessment of the Upper Extremity | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention |
|
From intervention up to 3-month evaluation after the end of the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Early termination of the study due to the budgetary issue leading to a smaller number of subjects recruited and fewer secondary outcome measures collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Cramer | University of California Irvine | (949) 824-8423 | SCCramer@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2018 | Jun 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Standard | Behavioral | 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. |
|
|
| Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention |
| Timed 10-meter Walk | We 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. | Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention |
| Box and Blocks Test | We 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. | Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention |
| Discharged to SNF, no transportation. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | 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, | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Modified Ashworth Spasticity Scale | We 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention |
|
|
|
| Secondary | Timed 10-meter Walk | We 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. | Posted | Mean | Standard Deviation | Seconds | Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention |
|
|
|
| Secondary | Box and Blocks Test | We 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. | Posted | Mean | Standard Deviation | blocks | Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| 3-month Follow Up |
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| 3-month Follow Up |
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| 3-month Follow Up |
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