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OpenTrials
Completed

NCT Number: NCT04800926

Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

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.

Completed

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xavier wheelchair controller

Device

Controlling a wheelchair using the Xavier surface EMG system

Primary outcomes

  1. Wheelchair Skills Test (WST)

    Time frame: approximately 3 days

    Questionnaire

Secondary outcomes

  1. Drive test

    Time frame: approximately 3 days

    Driving around cones in a controlled environment

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • University of Central Florida

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2021
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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