Wheelchair Cushion Comparison Study: SAFETY
Condition: Spinal Cord Injuries; Stroke; Healthy Adults
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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 Ease Alternating Pressure wheelchair cushion will be compared to a static
      air cushion to examine interface pressure and skin responses in the areas of the buttock and
      posterior thighs when subjects sit without moving (static condition) and during upper
      extremity reaching activities (active condition). In addition, comfort, ease of transfer, and
      postural stability will be monitored while sitting on both cushions under both static and
      active conditions.
    

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 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.
    

Intervention name(s): Alternating air wheelchair cushion; Static air cushion
Intervention type(s): Device; Device
Intervention description(s): The Ease alternating air cushion has longitudinal air bladders which alternately inflate and deflate at 3 minutes intervals in order to change the areas of pressure to the skin for areas in contact with the wheelchair cushion/seat (buttock and posterior thighs). The Ease Alternating Pressure wheelchair cushion is 510(k) exempt.; The Roho static air cushion is composed of multiple air bladders that are inflated to proper levels according to the individual's weight. This cushion is commonly used for individuals post spinal cord injury and sometime for individuals post stroke. The Roho wheelchair cushion is 510(k) exempt.
Other intervention name(s): Ease alternating air wheelchair cushion; Roho air cushion
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Supportive Care
Keywords: wheelchair cushion; pressure mapping; pressure wounds