Multicell Air Cushions: Sitting Posture and Limits of Stability

Balance Clinical Trial

Official title:

Wheelchair Seating: An Assessment of Multicell Air Cushions on Sitting Posture and Limits of Stability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05507788
• Other study ID #: ETAC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2023
• Source: Jonkoping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Balance
• Posture
• Self-Help Devices
• Wheelchairs

Intervention

Device:
• Wheelchair air cushion
Reaching tasks during each of the seating conditions decribed in the Arms section.

Locations

Country	Name	City	State
Sweden	Jönköping University	Jönköping

Sponsors (1)

Lead Sponsor	Collaborator
Jonkoping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach distance	the linear distance from the start position to the furthest reach point during the trial	Day 1
Primary	Accuracy	the ratio of the minimum distance (straight line) from the start position to the total distance traveled until the furthest reach point	Day 1
Primary	Time	length of time from the start position to furthest reached point	Day 1
Primary	total path length of Center of Pressure		Day 1
Primary	mean velocity of Center of Pressure		Day 1
Primary	pressure-distribution between the seating surface and the two foot Force-sensing arrays		Day 1