NCT02830893

Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

Completed NA Results posted Last updated 21 July 2020

What this trial tests

NA trial testing LARA in Cerebrovascular Accident in 23 participants. Completed in 10 January 2019.

Timeline

15 February 2017

Primary endpoint
10 January 2019

10 January 2019

Quick facts

Lead sponsor	University of California, Irvine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	23
Start date	15 February 2017
Primary completion	10 January 2019
Estimated completion	10 January 2019
Sites	1 location across United States

Drugs / interventions tested

• LARA
• Standard

Conditions studied

• Cerebrovascular Accident — all drugs for Cerebrovascular Accident →

Sponsor

University of California, Irvine

Who can join

Adults 18 to 80, any sex, with Cerebrovascular Accident. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fugl-Meyer (FM) Motor Assessment of the Upper Extremity Primary · Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention

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 Evaluation

Group	Value	95% CI
The LARA Therapy	28.5	± 11.6
The Standard Therapy	27.4	± 14.7

Change in Post therapy Evaluation

Group	Value	95% CI
The LARA Therapy	14.2	± 10.8
The Standard Therapy	7.9	± 3.8

Change in 3-month post-intervention

Group	Value	95% CI
The LARA Therapy	18.8	± 12.5
The Standard Therapy	14.1	± 7.4

Modified Ashworth Spasticity Scale Secondary · Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention

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 jo

Baseline Evaluation

Group	Value	95% CI
The LARA Therapy	0.64	± 0.64
The Standard Therapy	0.56	± 0.61

Post-Intervention Evaluation

Group	Value	95% CI
The LARA Therapy	0.47	± 0.56
The Standard Therapy	0.77	± 0.80

3-month Follow Up

Group	Value	95% CI
The LARA Therapy	0.61	± 0.72
The Standard Therapy	0.96	± 1.37

Timed 10-meter Walk Secondary · Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention

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 Evaluation

Group	Value	95% CI
The LARA Therapy	18.8	± 9.7
The Standard Therapy	23.4	± 9.1

Post-Intervention Evaluation

Group	Value	95% CI
The LARA Therapy	15.2	± 7.5
The Standard Therapy	14.4	± 5.0

3-month Follow Up

Group	Value	95% CI
The LARA Therapy	11.8	± 4.4
The Standard Therapy	11.8	± 3.7

Box and Blocks Test Secondary · Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention

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 Evaluation

Group	Value	95% CI
The LARA Therapy	8.5	± 10.8
The Standard Therapy	11.9	± 13.6

Post-Intervention Evaluation

Group	Value	95% CI
The LARA Therapy	23.5	± 19.2
The Standard Therapy	22.1	± 22.7

3-month Follow Up

Group	Value	95% CI
The LARA Therapy	53.4	± 31.8
The Standard Therapy	45.8	± 44.6

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Using a bimanual lever-driven wheelchair for arm movement practice early after stroke: A pilot, randomized, controlled, single-blind trial.
   Smith BW, Lobo-Prat J, Zondervan DK, Lew C, et al · · 2021 · cited 2× · PMID 34027703 · DOI 10.1177/02692155211014362