Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:10/26/2018
Start Date:February 15, 2017
End Date:August 20, 2018

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Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming

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.


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
We found this trial at
1
site
Irvine, California 92697
949-824-5011
Phone: 949-824-8423
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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