NCT05507788

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

April 28, 2022

Last Update Submit

March 7, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

Cushion

EXPERIMENTAL

Three seating conditons (Quadtro Select 10cm, Starlock 10cm, and Starlock 13cm)

Device: Wheelchair air cushion

Interventions

Reaching tasks during each of the seating conditions decribed in the Arms section.

Cushion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jönköping University

Jönköping, 55111, Sweden

Location

Study Officials

  • David F Rusaw, PhD

    Jonkoping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Efforts will be taken to mask the conditions to the participants.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The convenience sample of 15 individuals will each complete the test protocol under the 3 seating conditions in random order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2022

First Posted

August 19, 2022

Study Start

May 30, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations