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Completed

NCT Number: NCT03962582

Supportive Wheelchair Back Compared to Fabric Back

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Matrix back

Device

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

Primary outcomes

  1. Seated Body Measurements performed.

    Time frame: 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):

    Time frame: 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:

    Time frame: 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:

    Time frame: 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):

    Time frame: 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

    Time frame: 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:

    Time frame: 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

    Time frame: 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 outcomes

  1. Breathing status:

    Time frame: 2 hour session (one visit)

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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Craig Hospital
  • Motion Concepts
  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 24, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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