Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800926
• Other study ID #: 18-002369
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Device:
• Xavier wheelchair controller
Controlling a wheelchair using the Xavier surface EMG system

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of Central Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheelchair Skills Test (WST)	Questionnaire	approximately 3 days
Secondary	Drive test	Driving around cones in a controlled environment	approximately 3 days