Wheelchair Cushion Comparison Study: SAFETY
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Adults
- Spinal Cord Injuries
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Each of 3 populations or groups (healthy adults, participants post-stroke, participants with spinal cord injury) will sit on two wheelchair cushions (alternating air cushion, static air cushion) under two conditions including static sitting (#1 static condition) and while performing upper extremity reaching (#2 active condition) while monitoring interface pressure between the cushion and buttock/posterior thighs.Masking: None (Open Label)Masking Description: Participants, care providers if present, and investigators who are the outcomes assessors will all be aware of which cushion that the participant is sitting on, the participants' diagnoses or if healthy, the static and active conditions described above, and outcome measures results; therefore, no masking is taking place.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 20 years and 85 years
- Gender
- Both males and females
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 years) with a history of stroke (n=10) and spinal cord injury (n=10) with documented sensory impairme...
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 years) with a history of stroke (n=10) and spinal cord injury (n=10) with documented sensory impairment, but intact skin integrity in the area of the buttock and posterior thighs will also be recruited. Individuals post-stroke will likely have impaired sensation on one side of their buttock & leg; whereas, individuals post-spinal cord injury will likely have impaired sensation bilaterally in the buttock and posterior thigh areas. The goal is to recruit equal numbers of males and females with a variety of body builds (height, weight, and body mass index) across the age range in both groups. Procedures: In one 2 1/2 hour session, participants will a) sit still on [static condition] and b) perform the dynamic task of reaching in multiple directions [active condition] on the Ease alternating pressure cushion and on one static air cushion [randomized for order] for an estimated duration of one hour (32 minutes x two cushions) so that pressure mapping comparisons between cushions can be made. "The motion of the Ease cushions regularly shifts those points of pressure [every 3 minutes], and allows fresh blood to flow where the pressure has been lifted." Pressure mapping will capture the pressure amount, duration, and distribution of pressure between the skin of the buttock and posterior thighs and the wheelchair cushion surface. Documentation of the skin response (skin becomes pink, red, or blanches), and the participant's subjective opinions of comfort, ease of transfer, and postural stability will occur.
Tracking Information
- NCT #
- NCT03430375
- Collaborators
- JRD Enterprises LLC
- Michigan Corporate Relations Network Small Company Innovation Program
- Investigators
- Principal Investigator: Cathy A Larson, Ph.D. University of Michigan-Flint
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