Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2018
CompletedStudy Start
First participant enrolled
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedApril 1, 2024
March 1, 2024
10 months
December 28, 2018
March 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Wheelchair Skills Test (WST)
Questionnaire
approximately 3 days
Secondary Outcomes (1)
Drive test
approximately 3 days
Study Arms (1)
Xavier wheelchair controller
EXPERIMENTALSurface electromyography control of wheelchair
Interventions
Controlling a wheelchair using the Xavier surface EMG system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- University of Central Floridacollaborator
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Publications (1)
Manero AC, McLinden SL, Sparkman J, Oskarsson B. Evaluating surface EMG control of motorized wheelchairs for amyotrophic lateral sclerosis patients. J Neuroeng Rehabil. 2022 Aug 14;19(1):88. doi: 10.1186/s12984-022-01066-8.
PMID: 35965311BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bjorn Oskarsson, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 28, 2018
First Posted
March 16, 2021
Study Start
January 11, 2019
Primary Completion
October 30, 2019
Study Completion
October 30, 2019
Last Updated
April 1, 2024
Record last verified: 2024-03