Clinical trial NCT02830893: Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients
Official title: Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer (FM) Motor Assessment of the Upper Extremity
timeFrame: Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention
Secondary outcomes:
measure: Modified Ashworth Spasticity Scale
timeFrame: Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention
measure: Timed 10-meter Walk
timeFrame: Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention
measure: Box and Blocks Test
timeFrame: Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Steven Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.