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

NCT ID: NCT05742828

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2020-03-31

Brief 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.

Detailed 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Seating Coach

The Virtual Seating Coach is a context-aware reminding system that when set up by a clinician, directly benefits a user by reminding him or her to change position with the chair's power seating function.. Regular position changes increase independent function, reduce the risk of pressure ulcers, manage pain, and reduce swelling.

Group Type: ACTIVE_COMPARATOR

Virtual Seating Coach

Intervention Type: BEHAVIORAL

Power wheelchair intervention

Non Virtual Seating Coach

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Seating Coach

Power wheelchair intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Treatment group:

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

Comparison group:

• Inclusion will be diagnosis of ALS
• Current clinic client at The Carolinas Neuromuscular ALS/Muscular Dystrophy Association (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 the study, such as chairs from other regions or from the Veteran's Administration.

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 Language Pathologist/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 in addition 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 in addition to power wheelchair
• Further exclusions may be added in future protocol versions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Permobil, Inc.

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amber Ward, MS, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Carolinas Neuromuscular ALS/MDA Center

Locations

Atrium Health - Neurosciences Institute

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00082646

Identifier Type: -

Identifier Source: org_study_id