Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Mayo Clinic1 site in 1 country4 target enrollmentJanuary 11, 2019

ConditionsAmyotrophic Lateral Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: Mayo Clinic
Enrollment: 4
Locations: 1
Primary Endpoint: Wheelchair Skills Test (WST)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.

Registry

clinicaltrials.gov

Start Date

January 11, 2019

End Date

October 30, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Bjorn E. Oskarsson

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported)
•Age 18-89
•Limited mobility with use of motorized wheelchair at screening-time
•Impairment of hand function limiting the use of a standard joystick control
•Caregiver willing to assist with transfers into wheelchair and application of controllers
•Ability to attend study visits with a motorized wheelchair
•Ability to communicate and answer patient reported outcome measure questions

Exclusion Criteria

•Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of \<10 or the opinion of the investigator
•A sensory impairment prohibiting safe independent mobility in the opinion of the investigator
•Allergy to adhesives or electrode gels (required for EMG electrodes)
•Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes
•Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy
•Subjects who do not have the capacity to consent