Wheelchair Backs That Support the Spinal Curves
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Wheelchair (MWC) backrest configuration
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries
Eligibility 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
Sites / Locations
- Craig HospitalRecruiting
- Shirley Ryan AbilityLab
- Kessler Institute for Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
MWC Configuration 1
MWC Configuration 2
MWC Configuration 3
MWC Configuration 4
MWC Configuration 5
Arm Description
standard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle
active contour back positioned with seat gap and with free scapulae
active contour back positioned with seat gap and with blocked scapulae
deep contour back positioned with seat gap and with free scapulae
deep contour back positioned without seat gap and with free scapulae
Outcomes
Primary Outcome Measures
Pelvic Angle
Frontal Pelvic Angle
Secondary Outcome Measures
Spinal Angle of Kyphosis
Frontal Sternal Angle
Vertical Forward Reach Test (VFRT)
One Stroke Push Test
Timed Forward Wheeling
Timed ramp ascent
Full Information
NCT ID
NCT05068648
First Posted
September 14, 2021
Last Updated
August 28, 2023
Sponsor
Craig Hospital
Collaborators
Kessler Institute for Rehabilitation, Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT05068648
Brief Title
Wheelchair Backs That Support the Spinal Curves
Official Title
Wheelchair Backs That Support the Spinal Curves: Assessing Postural and Functional Changes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
Collaborators
Kessler Institute for Rehabilitation, Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MWC Configuration 1
Arm Type
Active Comparator
Arm Description
standard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle
Arm Title
MWC Configuration 2
Arm Type
Active Comparator
Arm Description
active contour back positioned with seat gap and with free scapulae
Arm Title
MWC Configuration 3
Arm Type
Active Comparator
Arm Description
active contour back positioned with seat gap and with blocked scapulae
Arm Title
MWC Configuration 4
Arm Type
Active Comparator
Arm Description
deep contour back positioned with seat gap and with free scapulae
Arm Title
MWC Configuration 5
Arm Type
Active Comparator
Arm Description
deep contour back positioned without seat gap and with free scapulae
Intervention Type
Other
Intervention Name(s)
Manual Wheelchair (MWC) backrest configuration
Intervention Description
Wheelchair backrest fitting, postural and functional assessment
Primary Outcome Measure Information:
Title
Pelvic Angle
Time Frame
Throughout study completion; average of 2 years.
Title
Frontal Pelvic Angle
Time Frame
Throughout study completion; average of 2 years.
Secondary Outcome Measure Information:
Title
Spinal Angle of Kyphosis
Time Frame
Throughout study completion; average of 2 years.
Title
Frontal Sternal Angle
Time Frame
Throughout study completion; average of 2 years.
Title
Vertical Forward Reach Test (VFRT)
Time Frame
Throughout study completion; average of 2 years.
Title
One Stroke Push Test
Time Frame
Throughout study completion; average of 2 years.
Title
Timed Forward Wheeling
Time Frame
Throughout study completion; average of 2 years.
Title
Timed ramp ascent
Time Frame
Throughout study completion; average of 2 years.
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Jaross, MPH
Phone
303-789-8970
Email
mjaross@craighospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Morey, MA
Phone
303-789-8621
Email
cmorey@craighospital.org
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Morey, MA
Phone
303-789-8621
Email
cmorey@craighospital.org
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Presperin Pedersen, OTD, MBA, ATP/SMS
Email
jpedersen@sralab.org
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Shea, OTR/L, ATP
Email
MShea@kessler-rehab.com
12. IPD Sharing Statement
Learn more about this trial
Wheelchair Backs That Support the Spinal Curves
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