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| Name | Class |
|---|---|
| Kessler Institute for Rehabilitation | INDUSTRY |
| Shirley Ryan AbilityLab | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MWC Configuration 1 | Active Comparator | standard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle |
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| MWC Configuration 2 | Active Comparator | active contour back positioned with seat gap and with free scapulae |
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| MWC Configuration 3 | Active Comparator | active contour back positioned with seat gap and with blocked scapulae |
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| MWC Configuration 4 | Active Comparator | deep contour back positioned with seat gap and with free scapulae |
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| MWC Configuration 5 | Active Comparator | deep contour back positioned without seat gap and with free scapulae |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Wheelchair (MWC) backrest configuration | Other | Wheelchair backrest fitting, postural and functional assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Angle | Throughout study completion; average of 2 years. | |
| Frontal Pelvic Angle | Throughout study completion; average of 2 years. |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113 | United States | ||
| Shirley Ryan AbilityLab |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States |
| D014947 | Wounds and Injuries |