Amyotrophic Lateral SclerosisALSNCT05742828
Virtual Seating Coach on Power Wheelchairs of Persons With Amyotrophic Lateral Sclerosis (ALS)
A study testing Virtual Seating Coach in people with Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Virtual Seating Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health - Neurosciences Institute
Charlotte, North Carolina, 28207
About this study
Official title: Virtual Seating Coach on Power Wheelchairs of Persons With ALS
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.
Read the 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
- Being tested
- Virtual Seating Coach
- Keywords
- Power wheelchairs, pressure injuries, pain
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Pressure Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Seating CoachBehavioural
Power wheelchair intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in seat function utilization with use of the Virtual Seating Coach (VSC)
tracked through the Virtual Seating Coach app and Permobil data collection
Measured: 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.
Measured: Year 3
Secondary outcomes (1)
Change in Utilization of VSC
If limitations are addressed (respiratory, cushion, comfort, control) does utilization increase? - evaluated with surveys and phone calls
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start20 Sep 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Permobil, Inc.
- Responsible party
- Sponsor
- Investigators
- Amber Ward, MS, OTR/L, Principal investigator, Carolinas Neuromuscular ALS/MDA Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742828
- Sponsor's protocol ID
- IRB00082646
- Acronym
- ALS
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Seating Coach on Power Wheelchairs of Persons With ALS
- ClinicalTrials.gov ID
- NCT05742828
- Acronym / sponsor ID
- ALS / IRB00082646
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Power wheelchairs, pressure injuries, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Permobil, Inc.
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Seating Coach | Active comparator | Behavioral: Virtual Seating CoachThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Seating CoachPower wheelchair intervention | Behavioural | Virtual Seating Coach |
Primary outcome
Change in seat function utilization with use of the Virtual Seating Coach (VSC)
Time frame: Year 3
tracked through the Virtual Seating Coach app and Permobil data collection
Change in number of Complications
Time frame: 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.
1 secondary outcome
Change in Utilization of VSC
Time frame: Year 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Ward, MS, OTR/L principal investigator
Carolinas Neuromuscular ALS/MDA Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Seating Coach in people with Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seat function utilization with use of the Virtual Seating Coach (VSC) (time frame: Year 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.