Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
Xavier wheelchair controller
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Bjorn Oskarsson, MD, Mayo Clinic
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Mayo Clinic
Estimated Enrollment:
4
Estimated Study Start Date:
01 / 11 / 2019
Estimated Study Completion Date:
10 / 30 / 2019
Posting Last Modified Date:
03 / 16 / 2021
Date Study Added to neals.org:
03 / 16 / 2021
Minimum Age:
18 Years
Maximum Age:
89 Years
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
Mayo Clinic in Florida
Jacksonville, Florida
32224
United States