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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05742828

Collaborator

Permobil, Inc. (Industry)

Enrollment

Location

Arms

30.3

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Behavioral: Virtual Seating Coach	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Virtual Seating Coach on Power Wheelchairs of Persons With ALS

Actual Study Start Date :

Sep 20, 2017

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Virtual Seating Coach Power wheelchair intervention
No 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: Virtual Seating Coach

Power wheelchair intervention

No 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.

Outcome Measures

Primary Outcome Measures

Change in seat function utilization with use of the Virtual Seating Coach (VSC) [Year 3]
tracked through the Virtual Seating Coach app and Permobil data collection
Change in number of Complications [Year 3]
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 [Year 3]
If limitations are addressed (respiratory, cushion, comfort, control) does utilization increase? - evaluated with surveys and phone calls

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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