Wheelchair Backs That Support the Spinal Curves

Wheelchair Backs That Support the Spinal Curves: Assessing Postural and Functional Changes

The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when using a solid backrest in individuals with spinal cord injury (SCI).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Manual Wheelchair (MWC) backrest configuration

Detailed Description

A properly fit wheelchair and seating system can have a profound impact on the daily life of people with spinal cord injury (SCI). A backrest that supports the natural spinal curves is thought to enhance posture, functional mobility, and comfort for manual wheelchair (MWC) users. In fact, therapists routinely prescribe after-market posture-backs based on clinical reasoning. However, there is little research comparing the efficacy of an after-market posture-back to the standard upholstery back, and it is becoming increasingly difficult to justify these to group insurance payers.

Based on this, investigators performed a pilot study to investigate whether there were postural and/or functional differences between using a standard upholstery WC back and an after-market solid posture-back. The results of that study have been presented at the American Congress of Rehabilitation Medicine (ACRM) annual conference in November 2019 and the Combined Sections Meeting (CSM) of the American Physical Therapy Association (APTA) in February 2020, and were also published in the Journal of Spinal Cord Medicine in 2020.

Although the results of that study demonstrated clinical relevance and statistical trends for improvements in postural alignment and functional outcomes when using a solid back, there was not enough power to establish statistical significance. It also did not evaluate the effect of backrest height and position or depth of contour in order to inform clinical practice. The overall objective of this fully powered clinical trial is to further investigate if using a solid backrest on MWC will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest; and to explore the impact of overall back height, seat gap, and contour when using a solid backrest.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan Abilitylab
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Full time manual wheelchair users
• Motor complete SCI from C6-T4
• Age 18-70 at time of testing
• Time since injury > 3 month at time of testing

Exclusion Criteria:

• Weight >250 pounds
• Current pressure ulcer at time of testing
• Significant shoulder pain that precludes independent mobility at time of testing
• Insufficient range of motion to achieve neutral pelvis and spine at time of testing
• Orthopedic restrictions requiring a brace that would impact functional outcome measures
• Shoulder flexion range of motion <120 degrees at time of testing
• PSIS-to-Inferior Angle of scapula measurement less than 8 inches or greater than 16 inches
• Cognitive deficits or visual impairment that would impair ability to give informed consent or to follow simple instructions during testing
• Children, pregnant women and prisoners will not participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MWC Configuration 1; standard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle	Other: Manual Wheelchair (MWC) backrest configuration; Wheelchair backrest fitting, postural and functional assessment
Active Comparator: MWC Configuration 2; active contour back positioned with seat gap and with free scapulae	Other: Manual Wheelchair (MWC) backrest configuration; Wheelchair backrest fitting, postural and functional assessment
Active Comparator: MWC Configuration 3; active contour back positioned with seat gap and with blocked scapulae	Other: Manual Wheelchair (MWC) backrest configuration; Wheelchair backrest fitting, postural and functional assessment
Active Comparator: MWC Configuration 4; deep contour back positioned with seat gap and with free scapulae	Other: Manual Wheelchair (MWC) backrest configuration; Wheelchair backrest fitting, postural and functional assessment
Active Comparator: MWC Configuration 5; deep contour back positioned without seat gap and with free scapulae	Other: Manual Wheelchair (MWC) backrest configuration; Wheelchair backrest fitting, postural and functional assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pelvic Angle	Throughout study completion; average of 2 years.
Frontal Pelvic Angle	Throughout study completion; average of 2 years.

Secondary Outcome Measures

Outcome Measure	Time Frame
Spinal Angle of Kyphosis	Throughout study completion; average of 2 years.
Frontal Sternal Angle	Throughout study completion; average of 2 years.
Vertical Forward Reach Test (VFRT)	Throughout study completion; average of 2 years.
One Stroke Push Test	Throughout study completion; average of 2 years.
Timed Forward Wheeling	Throughout study completion; average of 2 years.
Timed ramp ascent	Throughout study completion; average of 2 years.

Collaborators and Investigators

• Sponsor: Craig Hospital
• Collaborators: Shirley Ryan AbilityLab; Kessler Institute for Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: August 1, 2024

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: IRB#1788302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No