Supportive Wheelchair Back Compared to Fabric Back

NCT03962582 | Completed FDA Device

• 1 other identifier: STU00205806
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Breathing status:

  2 hour session (one visit)

Study Arms (1)

Supportive Back Comparison

EXPERIMENTAL

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

Interventions

Matrix back DEVICE

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

Supportive Back Comparison

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• complete spinal cord injury with levels
• Full time wheelchair users
• English speaking in order to understand the consent

You may not qualify if:

• Over 250 pounds in body weight
• Inability to grip a wheelchair push rim
• Individual with pressure ulcer
• Individual with shoulder pain

Sponsors & Collaborators

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

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: comparing two different back support to access if there are postural and functional differences.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 24, 2019
• Study Start: December 1, 2017
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)