Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

NCT02830893 | Completed Results FDA Device

• 1 other identifier: 2016-3304
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer (FM) Motor Assessment of the Upper Extremity

  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, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention

Secondary Outcomes (3)

• Modified Ashworth Spasticity Scale

  Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention

• Timed 10-meter Walk

  Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention

• Box and Blocks Test

  Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention

Study Arms (2)

The LARA Therapy

EXPERIMENTAL

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.

Device: LARA

The Standard Therapy

ACTIVE COMPARATOR

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.

Behavioral: Standard

Interventions

LARA DEVICE

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.

The LARA Therapy

Standard BEHAVIORAL

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.

Also known as: Conventional Arm and Hand Exercise Program

The Standard Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 34027703 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Early termination of the study due to the budgetary issue leading to a smaller number of subjects recruited and fewer secondary outcome measures collected.

Results Point of Contact

• Title: Dr. Steven Cramer
• Organization: University of California Irvine

SCCramer@mednet.ucla.edu

(949) 824-8423

Study Officials

• Steven Cramer, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 13, 2016
• Study Start: February 15, 2017
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: July 21, 2020
• Results First Posted: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)