NCT02830893

Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-02-15
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2016-07-13
• Last updated: 2020-07-21
• Results posted: 2020-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study