Supportive Wheelchair Back Compared to Fabric Back

Spinal Cord Injuries Clinical Trial

Official title:

Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962582
• Other study ID #: STU00205806
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: May 2019
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Matrix back
The Matrix back will replace the individual's back and the measures will be taken.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Craig Hospital, Motion Concepts, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seated Body Measurements performed.	Angle measurements will be taken when sitting. These include the pelvic angle (femur to pelvis) and Spinal Angle of Kyphosis (femur to acromion).	2 hour session (one visit)
Primary	Vertical Forward Reach Test (VFRT):	Assesses stability by measuring the maximum distance an individual can reach forward vertically (upward) while sitting in a fixed position.	2 hour session (one visit)
Primary	Breathing status:	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.	2 hour session (one visit)
Primary	One stroke push:	This measures how far the wheelchair moves forward with one stroke over carpet.	2 hour session (one visit)
Primary	Timed forward Wheeling/Wheelchair Propulsion Test (WPT):	The WPT is a brief test measuring the number of wheelchair pushes and time needed to cross a distance of 23 meters	2 hour session (one visit)
Primary	Ramp Ascent (forward wheeling	This is a timed test on a 10.3 meter ramp with a 1:13 grade slope	2 hour session (one visit)
Primary	Pain Scale:	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.	2 hour session (one visit)
Primary	Survey	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.	2 hour session (one visit)
Secondary	Breathing status:	Pulse oximetry will be taken with the person sitting in each testing wheelchair.	2 hour session (one visit)