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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Seating Coach
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring Power wheelchairs, pressure injuries, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atrium Health - Neurosciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Virtual Seating Coach

Non Virtual Seating Coach

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in seat function utilization with use of the Virtual Seating Coach (VSC)
tracked through the Virtual Seating Coach app and Permobil data collection
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.

Secondary Outcome Measures

Change in Utilization of VSC
If limitations are addressed (respiratory, cushion, comfort, control) does utilization increase? - evaluated with surveys and phone calls

Full Information

First Posted
February 15, 2023
Last Updated
May 3, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Permobil, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05742828
Brief Title
Virtual Seating Coach on Power Wheelchairs of Persons With Amyotrophic Lateral Sclerosis (ALS)
Acronym
ALS
Official Title
Virtual Seating Coach on Power Wheelchairs of Persons With ALS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Permobil, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Power wheelchairs, pressure injuries, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Seating Coach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non Virtual Seating Coach
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Seating Coach
Intervention Description
Power wheelchair intervention
Primary Outcome Measure Information:
Title
Change in seat function utilization with use of the Virtual Seating Coach (VSC)
Description
tracked through the Virtual Seating Coach app and Permobil data collection
Time Frame
Year 3
Title
Change in number of Complications
Description
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.
Time Frame
Year 3
Secondary Outcome Measure Information:
Title
Change in Utilization of VSC
Description
If limitations are addressed (respiratory, cushion, comfort, control) does utilization increase? - evaluated with surveys and phone calls
Time Frame
Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Ward, MS, OTR/L
Organizational Affiliation
Carolinas Neuromuscular ALS/MDA Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health - Neurosciences Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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