Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT04800926
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-28
• Study Start: 2019-01-11
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Wheelchair Skills Test (WST)	approximately 3 days	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Drive test	approximately 3 days	Driving around cones in a controlled environment

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States