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Wheelchair Backs That Support the Spinal Curves

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05068648
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : May 31, 2022
Sponsor:
Collaborators:
Kessler Institute for Rehabilitation
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Candace Tefertiller, Craig Hospital

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Manual Wheelchair (MWC) backrest configuration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Wheelchair Backs That Support the Spinal Curves: Assessing Postural and Functional Changes
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pelvic Angle [ Time Frame: Throughout study completion; average of 2 years. ]
  2. Frontal Pelvic Angle [ Time Frame: Throughout study completion; average of 2 years. ]

Secondary Outcome Measures :
  1. Spinal Angle of Kyphosis [ Time Frame: Throughout study completion; average of 2 years. ]
  2. Frontal Sternal Angle [ Time Frame: Throughout study completion; average of 2 years. ]
  3. Vertical Forward Reach Test (VFRT) [ Time Frame: Throughout study completion; average of 2 years. ]
  4. One Stroke Push Test [ Time Frame: Throughout study completion; average of 2 years. ]
  5. Timed Forward Wheeling [ Time Frame: Throughout study completion; average of 2 years. ]
  6. Timed ramp ascent [ Time Frame: Throughout study completion; average of 2 years. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068648


Contacts
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Contact: Marissa Jaross, MPH 303-789-8970 mjaross@craighospital.org
Contact: Clare Morey, MA 303-789-8621 cmorey@craighospital.org

Locations
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United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Clare Morey, MA    303-789-8621    cmorey@craighospital.org   
United States, Illinois
Shirley Ryan AbilityLab Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Jessica Presperin Pedersen, OTD, MBA, ATP/SMS       jpedersen@sralab.org   
United States, New Jersey
Kessler Institute for Rehabilitation Not yet recruiting
West Orange, New Jersey, United States, 07052
Contact: Mary Shea, OTR/L, ATP       MShea@kessler-rehab.com   
Sponsors and Collaborators
Craig Hospital
Kessler Institute for Rehabilitation
Shirley Ryan AbilityLab
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Candace Tefertiller, Executive Director of Research and Evaluation, Craig Hospital
ClinicalTrials.gov Identifier: NCT05068648    
Other Study ID Numbers: IRB#1788302
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries