Spinal Cord Injuries Clinical Trial
Official title:
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).
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
United States | Craig Hospital | Englewood | Colorado |
United States | Kessler Institute for Rehabilitation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Craig Hospital | Kessler Institute for Rehabilitation, Shirley Ryan AbilityLab |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pelvic Angle | Throughout study completion; average of 2 years. | ||
Primary | Frontal Pelvic Angle | Throughout study completion; average of 2 years. | ||
Secondary | Spinal Angle of Kyphosis | Throughout study completion; average of 2 years. | ||
Secondary | Frontal Sternal Angle | Throughout study completion; average of 2 years. | ||
Secondary | Vertical Forward Reach Test (VFRT) | Throughout study completion; average of 2 years. | ||
Secondary | One Stroke Push Test | Throughout study completion; average of 2 years. | ||
Secondary | Timed Forward Wheeling | Throughout study completion; average of 2 years. | ||
Secondary | Timed ramp ascent | Throughout study completion; average of 2 years. |
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