Supportive Wheelchair Back Compared to Fabric Back

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Matrix back

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Supportive Back Comparison; 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	Device: Matrix back; The Matrix back will replace the individual's back and the measures will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
One stroke push:	This measures how far the wheelchair moves forward with one stroke over carpet.	2 hour session (one visit)
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)
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)
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)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: The Craig H. Neilsen Foundation; Craig Hospital; Motion Concepts

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: STU00205806

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: Yes
• product manufactured in and exported from the U.S.: No