Multicell Air Cushions: Sitting Posture and Limits of Stability

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Wheelchairs; Balance; Posture; Self-Help Devices; Sitting Position; Limits of Stability
• Intervention / Treatment: Device: Wheelchair air cushion

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Jönköping, Sweden, 55111
    • Jonkoping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cushion; Three seating conditons (Quadtro Select 10cm, Starlock 10cm, and Starlock 13cm)	Device: Wheelchair air cushion; Reaching tasks during each of the seating conditions decribed in the Arms section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach distance	the linear distance from the start position to the furthest reach point during the trial	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	Day 1
Time	length of time from the start position to furthest reached point	Day 1
total path length of Center of Pressure		Day 1
mean velocity of Center of Pressure		Day 1
pressure-distribution between the seating surface and the two foot Force-sensing arrays		Day 1

Collaborators and Investigators

• Sponsor: Jonkoping University
• Investigators: Principal Investigator: David F Rusaw, PhD, Jonkoping University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ETAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No