Supportive Wheelchair Back Compared to Fabric Back

• Sponsor: Shirley Ryan AbilityLab (Other)
• Overall Status: Completed
• CT.gov ID: NCT03962582
• Collaborator: Craig Hospital (Other), Motion Concepts (Other), The Craig H. Neilsen Foundation (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Device: Matrix back	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: comparing two different back support to access if there are postural and functional differences.comparing two different back support to access if there are postural and functional differences.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Mar 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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.

3. 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.

4. One stroke push: [2 hour session (one visit)]

   This measures how far the wheelchair moves forward with one stroke over carpet.

5. 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

6. 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

7. 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.

8. 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

1. Breathing status: [2 hour session (one visit)]

   Pulse oximetry will be taken with the person sitting in each testing wheelchair.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shirley Ryan AbilityLab	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Shirley Ryan AbilityLab
• Craig Hospital
• Motion Concepts
• The Craig H. Neilsen Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica Pedersen, Research Scientist, Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT03962582
• Other Study ID Numbers: STU00205806
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of May 24, 2019