Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients
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|ClinicalTrials.gov Identifier: NCT02830893|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Device: LARA Behavioral: Standard||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming|
|Actual Study Start Date :||February 15, 2017|
|Actual Primary Completion Date :||August 20, 2018|
|Actual Study Completion Date :||August 20, 2018|
Experimental: 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.
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.
Active Comparator: 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.
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.
Other Name: Conventional Arm and Hand Exercise Program
- Arm Motor Fugl-Meyer (FM) score [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]Evaluates and measures arm motor recovery after stroke
- Action Research Arm Test (ARAT) [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]Evaluates and measures arm motor recovery after stroke
- Motor Activity Log [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]Self report of arm use after stroke using a Likert scale
- Modified Ashworth Spasticity Scale [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]To evaluate and measure of spasticity of the upper extremity after stroke
- Timed 10-meter walk [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]To measure gait velocity for a distance of 10 meters
- Box and Block Test [ Time Frame: from baseline visit to 3-month visit after the end of intervention ]To measure unilateral gross manual dexterity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830893
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92697|
|Principal Investigator:||Steven Cramer, MD||University of California, Irvine|