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CompletedNCT04800926Updated Apr 1, 2024

Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

An interventional study of Xavier wheelchair controller in Amyotrophic Lateral Sclerosis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Oct 2019, 6 years 11 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 4 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Xavier wheelchair controller

    Surface electromyography control of wheelchair

    Device: Xavier wheelchair controller

Interventions

  • DeviceXavier wheelchair controller

    Controlling a wheelchair using the Xavier surface EMG system

06

What researchers measure

Primary outcomes

  1. Wheelchair Skills Test (WST)

    Questionnaire

    Time frame: approximately 3 days

Secondary outcomes

  1. Drive test

    Driving around cones in a controlled environment

    Time frame: approximately 3 days

07

Study locations

1 site
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
08

References and documents

Publications

  • 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. PubMed 35965311 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04800926
Lead sponsor
Mayo Clinic
Collaborators
University of Central Florida
Responsible party
Bjorn E. Oskarsson (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 16, 2021
Start date
Jan 11, 2019
Primary completion
Oct 30, 2019
Completion
Oct 30, 2019
Last update
Apr 1, 2024

Study contacts

Bjorn Oskarsson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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