Back to resultsXavier Electromyographic Wheelchair Control for Limited Mobility Patients
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xavier wheelchair controller
Sponsored by
About this trial
This is an interventional device feasibility trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xavier wheelchair controller
Arm Description
Surface electromyography control of wheelchair
Outcomes
Primary Outcome Measures
Wheelchair Skills Test (WST)
Questionnaire
Secondary Outcome Measures
Drive test
Driving around cones in a controlled environment
Full Information
NCT ID
NCT04800926
First Posted
December 28, 2018
Last Updated
March 14, 2021
Sponsor
Mayo Clinic
Collaborators
University of Central Florida
1. Study Identification
Unique Protocol Identification Number
NCT04800926
Brief Title
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Official Title
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Central Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xavier wheelchair controller
Arm Type
Experimental
Arm Description
Surface electromyography control of wheelchair
Intervention Type
Device
Intervention Name(s)
Xavier wheelchair controller
Intervention Description
Controlling a wheelchair using the Xavier surface EMG system
Primary Outcome Measure Information:
Title
Wheelchair Skills Test (WST)
Description
Questionnaire
Time Frame
approximately 3 days
Secondary Outcome Measure Information:
Title
Drive test
Description
Driving around cones in a controlled environment
Time Frame
approximately 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjorn Oskarsson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35965311
Citation
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.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
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