Study of Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-002369
NCT ID: NCT04800926
Sponsor Protocol Number: 18-002369
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Bjorn Oskarsson, M.D. |
Closed for enrollment |
|
More information
Publications
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This study evaluated a novel control method for patients unable to independently control powered wheelchairs. Patients with amyotrophic lateral sclerosis often require a wheelchair but struggle with sufficient hand dexterity required for joystick control making them a population that needs this type of control method.
Read More on PubMed