Status:
COMPLETED
Wheelchair Cushion Comparison Study: SAFETY
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
JRD Enterprises LLC
Michigan Corporate Relations Network Small Company Innovation Program
Conditions:
Spinal Cord Injuries
Stroke
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
Purpose: To examine the safety of the use of two wheelchair cushions for healthy individuals with intact sensation and individuals post stroke and spinal cord injury with impaired sensation. The new E...
Detailed Description
Twenty healthy adults (age range = 20 - 85 years) with intact buttock and bilateral posterior thigh sensation and intact skin integrity will be recruited. Twenty additional individuals (ages 20 - 85 y...
Eligibility Criteria
Inclusion
- Control: Healthy adults
- no sensation or skin issues in the buttock or posterior thigh areas
- Experimental groups: Diagnoses of stroke and spinal cord injury
- Impaired or absent sensation in the unilateral or bilateral buttock and posterior thigh areas
- No other reasons to have impaired sensation in the buttock and posterior thighs other than stroke or spinal cord injury (i.e. no peripheral nerve damage)
- No current wounds or a history of wounds (past 6 months) involving the buttock, greater trochanters, or posterior thighs
- Control and Experimental groups
- \- Bilateral hips and knees: passive range of motion at least 90 degrees
Exclusion
- Control and Experimental groups - No self-reported cardiac, pulmonary, orthopedic, or neurological issues that would prevent sitting or performing reaching activities while sitting on the cushions for a one-hour total duration
- Experimental group
- \- No neurological diseases other than stroke or spinal cord injury
Key Trial Info
Start Date :
May 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03430375
Start Date
May 31 2018
End Date
August 31 2021
Last Update
September 1 2021
Active Locations (1)
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1
University of Michigan - Flint
Flint, Michigan, United States, 48502