Virtual Seating Coach on Power Wheelchairs of Persons With Amyotrophic Lateral Sclerosis (ALS)

Last updated: May 3, 2023
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Scar Tissue

Myasthenia Gravis (Chronic Weakness)

Treatment

Virtual Seating Coach

Clinical Study ID

NCT05742828
IRB00082646
  • Ages > 18
  • All Genders

Study Summary

A literature review was completed related to the topic of use of the Virtual Seating Coach (VSC) device with clients with Amyotrophic Lateral Sclerosis (ALS) with no results. The VSC components are FDA approved and Health Insurance Portability and Accountability Act (HIPPA) compliant, which have been used for many years by clinicians to achieve therapy goals of repositioning and best practice of utilizing power wheelchair seat functioning on a frequent basis. The VSC is typically not covered by insurance, but with clinical documentation, it has the potential for reimbursement. There is conflicting and vague information in the literature with regards to the prevalence/types of wounds and prevalence of pain in this population.

Eligibility Criteria

Inclusion

Inclusion Criteria: Treatment group:

  • Inclusion will be diagnosis of amyotrophic lateral sclerosis (ALS)
  • Current clinic client at The Carolinas Neuromuscular ALS/MDA Center'sMultidisciplinary ALS clinic
  • Currently using a Permobil power wheelchair with power seating with R-Net electronicsthat accepts the VSC
  • Has a Permobil Corpus 3G (6 months old or newer) or who order a new Permobil powerwheelchair.
  • New Permobil chairs which are not obtained through this clinic will also be able toenter the study, such as chairs from other regions or from the Veteran'sAdministration. Comparison group:
  • Inclusion will be diagnosis of ALS
  • Current clinic client at The Carolinas Neuromuscular ALS/Muscular DystrophyAssociation (MDA) Center's multidisciplinary ALS clinic
  • Currently using a power wheelchair with power seating.
  • New chairs which are not obtained through this clinic will also be able to enter thestudy, such as chairs from other regions or from the Veteran's Administration.

Exclusion

Exclusion Criteria: Treatment group:

  • Another diagnosis besides ALS
  • Does not have a Smart phone or tablet
  • Frontotemporal Dementia as noted by MD/SLP/SW (Medical Doctor/Speech LanguagePathologist/Social Worker) in medical records
  • Inability/unwillingness to control wheelchair power features (client)
  • Unwillingness to be monitored by study staff and alerted by VSC over time
  • Uses other mobility devices indoors (scooter, basic power wheelchair) more than or inaddition to Permobil PWC Comparison group:
  • Another diagnosis besides ALS
  • Frontotemporal Dementia as noted by MD/SLP/SW in medical records
  • Inability/unwillingness to control wheelchair power features (client)
  • Unwillingness to be monitored by study staff
  • Uses other mobility devices indoors (scooter, basic power wheelchair) more than or inaddition to power wheelchair
  • Further exclusions may be added in future protocol versions

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Virtual Seating Coach
Phase:
Study Start date:
September 20, 2017
Estimated Completion Date:
March 31, 2020

Study Description

According to most literature, clients with ALS in general, get few pressure injuries. At this clinic, however, potentially due to the longer life expectancy of clients who choose tracheostomy with mechanical ventilation and a feeding tube, some clients do get pressure injuries. Also, many clients once they are sitting most of the day, whether in the wheelchair, recliner or bed, complain of discomfort and pain. Most clients will use or require a power wheelchair for mobility and positioning in the course of the disease process, and many will require it full time as symptoms progress. Generally, decreased sensation is not a symptom of ALS, but it is unknown why some people with ALS have pain and pressure injuries despite the intact sensation needed to cue repositioning.

It is best clinical practice to provide clients with ALS power wheelchairs that tilt, recline, and have leg elevation for maximal pressure management and to encourage repositioning to reduce the risk of skin breakdown/pressure injury as well as decrease pain. This study will study the effect of having an alerting/coaching system for training and reminders on performing pressure relief and repositioning for decreasing the number of pressure injuries as well as decreasing pain. The VSC also gives contextual cues to achieve a specific angle set-up by the clinician. Not only does the VSC provide alerts, but the client and clinician can observe and track the amount of time the chair is on and in what position.

Connect with a study center

  • Atrium Health - Neurosciences Institute

    Charlotte, North Carolina 28207
    United States

    Site Not Available

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