ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02830893
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: LARA Behavioral: Standard Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: The LARA Therapy
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
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.
Active Comparator: The Standard Therapy
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
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.
Other Name: Conventional Arm and Hand Exercise Program



Primary Outcome Measures :
  1. Arm Motor Fugl-Meyer (FM) score [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]
    Evaluates and measures arm motor recovery after stroke


Secondary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]
    Evaluates and measures arm motor recovery after stroke

  2. Motor Activity Log [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]
    Self report of arm use after stroke using a Likert scale

  3. Modified Ashworth Spasticity Scale [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]
    To evaluate and measure of spasticity of the upper extremity after stroke

  4. Timed 10-meter walk [ Time Frame: from baseline visit to the 3-month visit after the end of intervention ]
    To measure gait velocity for a distance of 10 meters

  5. Box and Block Test [ Time Frame: from baseline visit to 3-month visit after the end of intervention ]
    To measure unilateral gross manual dexterity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830893


Contacts
Contact: Vicky Chan, MSPT (949) 824-8423 vchan2@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Vicky Chan, MSPT    949-824-8423    vchan2@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Steven Cramer, MD University of California, Irvine

Responsible Party: Steven C. Cramer, MD, Professor of Neurology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02830893     History of Changes
Other Study ID Numbers: 2016-3304
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases