Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

March 28, 2024 updated by: Bjorn E. Oskarsson, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xavier wheelchair controller
Surface electromyography control of wheelchair
Device: Xavier wheelchair controller
Controlling a wheelchair using the Xavier surface EMG system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wheelchair Skills Test (WST)
Time Frame: approximately 3 days
Questionnaire
approximately 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drive test
Time Frame: approximately 3 days
Driving around cones in a controlled environment
approximately 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

University of Central Florida

Investigators

  • Principal Investigator: Bjorn Oskarsson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

December 28, 2018

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-002369

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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