WheelchairsNCT05507788
Multicell Air Cushions: Sitting Posture and Limits of Stability
A study testing Wheelchair air cushion in people with Wheelchairs and Self-Help Devices, run by Jonkoping University at 1 site in Sweden.
Trial summary
The study's aim is to assess the sitting and dynamic postural control of stability of wheelchair users who have compromised postural control and risk of ulcers while using individually adjusted multi-cell air cushions with and without individual cell-locking function and variable depths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wheelchairs, Self-Help Devices, Posture
- What is being tested?
- Wheelchair air cushion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 30 May 2022to 31 Mar 2023
- 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
- individuals who use a wheelchair
- have used a wheelchair for no less than 2 years
- score from 3-6 on the Functional Independence Measure
- not currently inpatients or those currently accessing acute care for concomitant health-related issues
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wheelchair Seating: An Assessment of Multicell Air Cushions on Sitting Posture and Limits of Stability
The study's aim is to assess the sitting and dynamic postural control of stability of wheelchair users who have compromised postural control and risk of ulcers while using individually adjusted multi-cell air cushions with and without individual cell-locking function and variable depths.
- Conditions
- Wheelchairs, Self-Help Devices, Posture, Sitting Position, Limits of Stability, Balance
- Being tested
- Wheelchair air cushion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair air cushionDevice
Reaching tasks during each of the seating conditions decribed in the Arms section.
| Study group | Role | What they receive |
|---|---|---|
| Cushion | Experimental | Three seating conditons (Quadtro Select 10cm, Starlock 10cm, and Starlock 13cm) Receives: Device: Wheelchair air cushion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach distance
the linear distance from the start position to the furthest reach point during the trial
Measured: Day 1
Accuracy
the ratio of the minimum distance (straight line) from the start position to the total distance traveled until the furthest reach point
Measured: Day 1
Time
length of time from the start position to furthest reached point
Measured: Day 1
total path length of Center of Pressure
Measured: Day 1
mean velocity of Center of Pressure
Measured: Day 1
pressure-distribution between the seating surface and the two foot Force-sensing arrays
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start30 May 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheelchairsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The convenience sample of 15 individuals will each complete the test protocol under the 3 seating conditions in random order.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonkoping University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rusaw, Jonkoping University
- Investigators
- David F Rusaw, PhD, Principal investigator, Jonkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507788
- Sponsor's protocol ID
- ETAC
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2022
- Last updated
- 8 Mar 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 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair Seating: An Assessment of Multicell Air Cushions on Sitting Posture and Limits of Stability
- ClinicalTrials.gov ID
- NCT05507788
- Acronym / sponsor ID
- ETAC
- Conditions
- Wheelchairs, Self-Help Devices, Posture, Sitting Position, Limits of Stability, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jonkoping UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 19 Aug 2022 (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.
The study's aim is to assess the sitting and dynamic postural control of stability of wheelchair users who have compromised postural control and risk of ulcers while using individually adjusted multi-cell air cushions with and without individual cell-locking function and variable depths.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The convenience sample of 15 individuals will each complete the test protocol under the 3 seating conditions in random order.
| Arm | Type | Receives |
|---|---|---|
| Cushion | Experimental | Device: Wheelchair air cushionThree seating conditons (Quadtro Select 10cm, Starlock 10cm, and Starlock 13cm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals who use a wheelchair
- have used a wheelchair for no less than 2 years
- score from 3-6 on the Functional Independence Measure
- not currently inpatients or those currently accessing acute care for concomitant health-related issues
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Wheelchair air cushionReaching tasks during each of the seating conditions decribed in the Arms section. | Device | Cushion |
Primary outcome
Reach distance
Time frame: Day 1
the linear distance from the start position to the furthest reach point during the trial
Accuracy
Time frame: Day 1
the ratio of the minimum distance (straight line) from the start position to the total distance traveled until the furthest reach point
Time
Time frame: Day 1
length of time from the start position to furthest reached point
total path length of Center of Pressure
Time frame: Day 1
mean velocity of Center of Pressure
Time frame: Day 1
pressure-distribution between the seating surface and the two foot Force-sensing arrays
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 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.
David F Rusaw, PhD principal investigator
Jonkoping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair air cushion in people with Wheelchairs and Self-Help Devices, run by Jonkoping University at 1 site in Sweden.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Sweden. 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?
Results are not available in the source record.
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?
Reach distance (time frame: Day 1). The study lists 6 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 8 Mar 2023.