Status:
COMPLETED
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of Central Florida
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-89 years
Phase:
NA
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 joysti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04800926
Start Date
January 11 2019
End Date
October 30 2019
Last Update
April 1 2024
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224