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

NCT05742828 | Completed

• 1 other identifier: IRB00082646
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Power wheelchairs; pressure injuries; pain

Outcome Measures

Primary Outcomes (2)

• Change in seat function utilization with use of the Virtual Seating Coach (VSC)

  tracked through the Virtual Seating Coach app and Permobil data collection

  Year 3

• Change in number of Complications

  Pressure and pain questions measured using a Likert Scale - A type of psychometric response scale in which responders specify their level of agreement to a statement typically in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.

  Year 3

Secondary Outcomes (1)

• Change in Utilization of VSC

  Year 3

Study Arms (2)

Virtual Seating Coach

ACTIVE COMPARATOR

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.

Behavioral: Virtual Seating Coach

Non Virtual Seating Coach

NO INTERVENTION

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.

Interventions

Virtual Seating Coach BEHAVIORAL

Power wheelchair intervention

Virtual Seating Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment group:
• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Permobil, Inc.: collaborator

Study Sites (1)

Atrium Health - Neurosciences Institute

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Pressure Ulcer; Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amber Ward, MS, OTR/L

  Carolinas Neuromuscular ALS/MDA Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: September 20, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)