Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

NCT ID: NCT04800926

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2019-10-30

Brief Summary

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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

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Xavier wheelchair controller

Surface electromyography control of wheelchair

Group Type EXPERIMENTAL

Xavier wheelchair controller

Intervention Type DEVICE

Controlling a wheelchair using the Xavier surface EMG system

Interventions

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Xavier wheelchair controller

Controlling a wheelchair using the Xavier surface EMG system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Central Florida

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Bjorn E. Oskarsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bjorn Oskarsson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35965311 (View on PubMed)

Related Links

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Other Identifiers

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18-002369

Identifier Type: -

Identifier Source: org_study_id

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