Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Mayo Clinic

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: Xavier wheelchair controller

Study type: Interventional

Funder types: Other

Identifiers

NCT04800926

18-002369

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Xavier wheelchair controller

Experimental group

Description:

Surface electromyography control of wheelchair

Treatment:

Device: Xavier wheelchair controller