Supportive Wheelchair Back Compared to Fabric Back

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Device: Matrix back

• Registration Number: NCT03962582
• Lead Sponsor: Shirley Ryan AbilityLab

Brief Summary

This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.

Detailed Description

Individuals will randomly start with the supportive back vs the unsupportive back. Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push, times forward push and ramp skills will be assessed.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Study First Submitted: 2019-04-22
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-24
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• complete spinal cord injury with levels
• Full time wheelchair users
• English speaking in order to understand the consent

Exclusion Criteria

• Over 250 pounds in body weight
• Inability to grip a wheelchair push rim
• Individual with pressure ulcer
• Individual with shoulder pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Back Comparison	Matrix back	Motion Concepts matrx back to be attached to individual's wheelchair in place of the individual's back. It will be adjusted for size and to support the spinal curves as compared to a fabric back

Primary Outcome Measures

Name	Time	Method
Seated Body Measurements performed.	2 hour session (one visit)	Angle measurements will be taken when sitting. These include the pelvic angle (femur to pelvis) and Spinal Angle of Kyphosis (femur to acromion).
Vertical Forward Reach Test (VFRT):	2 hour session (one visit)	Assesses stability by measuring the maximum distance an individual can reach forward vertically (upward) while sitting in a fixed position.
Breathing status:	2 hour session (one visit)	An instrument called a spirometer is placed into the mouth with the nose clipped and the individual is instructed to take a deep breath and blow out. Peak effort flow, peak cough flow, and functional capacity will be recorded.
One stroke push:	2 hour session (one visit)	This measures how far the wheelchair moves forward with one stroke over carpet.
Timed forward Wheeling/Wheelchair Propulsion Test (WPT):	2 hour session (one visit)	The WPT is a brief test measuring the number of wheelchair pushes and time needed to cross a distance of 23 meters
Ramp Ascent (forward wheeling	2 hour session (one visit)	This is a timed test on a 10.3 meter ramp with a 1:13 grade slope
Pain Scale:	2 hour session (one visit)	The participant will rate any pain felt while sitting in the test wheelchairs after all activities using a numerical scale of 0-10, with 0 being no pain.
Survey	2 hour session (one visit)	The study team developed a survey for patients to fill out asking questions such as comfort of back support and opinions of practicality of back support.

Secondary Outcome Measures

Name	Time	Method
Breathing status:	2 hour session (one visit)	Pulse oximetry will be taken with the person sitting in each testing wheelchair.

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States