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Supportive Wheelchair Back Compared to Fabric Back

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Matrix back
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Back Comparison

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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.
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.
One stroke push:
This measures how far the wheelchair moves forward with one stroke over carpet.
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
Ramp Ascent (forward wheeling
This is a timed test on a 10.3 meter ramp with a 1:13 grade slope
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2019
Last Updated
May 22, 2019
Sponsor
Shirley Ryan AbilityLab
Collaborators
Craig Hospital, Motion Concepts, The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03962582
Brief Title
Supportive Wheelchair Back Compared to Fabric Back
Official Title
Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Craig Hospital, Motion Concepts, The Craig H. Neilsen Foundation

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
comparing two different back support to access if there are postural and functional differences.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Supportive Wheelchair Back Compared to Fabric Back

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