Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

Recruiting

Phase N/A Results N/A

Trial 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.

Conditions

Interventions

  • Standard Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: The Standard Therapy
    Description: 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.
  • LARA Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: The LARA Therapy
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Arm Motor Fugl-Meyer (FM) score from baseline visit to the 3-month visit after the end of intervention No
Secondary Action Research Arm Test (ARAT) from baseline visit to the 3-month visit after the end of intervention No
Secondary Motor Activity Log from baseline visit to the 3-month visit after the end of intervention No
Secondary Active and Passive Range of Motion at the shoulder from baseline visit to the 3-month visit after the end of intervention No
Secondary Active and Passive Range of Motion at the elbow from baseline visit to the 3-month visit after the end of intervention No
Secondary Modified Ashworth Spasticity Scale from baseline visit to the 3-month visit after the end of intervention No
Secondary Timed 10-meter walk from baseline visit to the 3-month visit after the end of intervention No
Secondary Box and Block Test from baseline visit to 3-month visit after the end of intervention

Sponsors