Amyotrophic Lateral Sclerosis
Conditions
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.
Interventions
DEVICEXavier wheelchair controller
Controlling a wheelchair using the Xavier surface EMG system
Sponsors
University of Central Florida
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wheelchair Skills Test (WST) | approximately 3 days | Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drive test | approximately 3 days | Driving around cones in a controlled environment |
Countries
United States
Outcome results
None listed