Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

University of California Irvine (UCI)

Status: Completed

Conditions: Cerebrovascular Accident

Treatments: Behavioral: Standard; Device: LARA

Study type: Interventional

Funder types: Other

Identifiers

NCT02830893

2016-3304

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years at the time of enrollment
2. Stroke onset 1-4 weeks prior to study enrollment
3. Arm motor FM score of < 30 (out of 66) at Baseline Visit
4. Absence of moderate to severe shoulder pain ( Score <3 on the 10 point visual analog pain scale)
5. Any deficit in vision, alertness, language, attention, or other cognitive functions that interfere with playing the LARA games

Exclusion criteria

1. Age >80 years at the time of enrollment
2. Severe tone in the affected upper extremities (Score ≥ 4 on the Modified Ashworth Spasticity Scale)
3. Severe language problem that would prevent participants from properly understanding instructions
4. Severe reduced level of consciousness
5. Severe aphasia (score of 3 on the NIH stroke scale (question 9))
6. Severe loss of sensation in stroke-affected upper extremities (Score < 1 on the Nottingham sensory assessment)
7. Currently pregnant
8. Difficulty in understanding or complying with the instructions given by the experimenter
9. Inability to perform the experimental task that will be studied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

The LARA Therapy

Experimental group

Description:

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.

Treatment:

Device: LARA

The Standard Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard