Wheelchair Cushion Comparison Study: SAFETY

Comparison of the Safety of an Alternating-air-pressure and a Static Air Wheelchair Cushion for Healthy Adults and Adults With Spinal Cord Injury or Post-stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Spinal Cord Injuries; Healthy Adults
• Intervention / Treatment: Device: Alternating air wheelchair cushion; Device: Static air cushion

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48502
      • University of Michigan - Flint

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alternating air then static air cushion; The participants in all three populations or groups (healthy adults, adults with stroke, and adults with spinal cord injury) will first sit on the alternating air wheelchair cushion for 32 minutes and then the static air cushion for 32 minutes under two conditions (static: sitting without intentional moving) and (active: reaching with their upper extremity) while pressure mapping and skin responses are recorded. The Ease alternating air wheelchair cushion inflates/deflates which shifts the points of pressure [every 3 minutes] and allows fresh blood to flow where the pressure has been lifted. The Roho static air cushion is a common wheelchair cushion currently used for pressure relief purposes.	Device: Alternating air wheelchair cushion; 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.; Other Names: Ease alternating air wheelchair cushion; Device: Static air cushion; 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 Names: Roho air cushion
Active Comparator: Static air then alternating air cushion; The participants in all three populations or groups (healthy adults, adults with stroke, and adults with spinal cord injury) will first sit on the static air wheelchair cushion for 32 minutes and then the alternating air cushion for 32 minutes under two conditions (static: sitting without intentional moving) and (active: reaching with their upper extremity) while pressure mapping and skin responses are recorded. The Roho static air cushion is a common wheelchair cushion currently used for pressure relief purposes. The Ease alternating air wheelchair cushion inflates/deflates which shifts the points of pressure [every 3 minutes] and allows fresh blood to flow where the pressure has been lifted.	Device: Alternating air wheelchair cushion; 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.; Other Names: Ease alternating air wheelchair cushion; Device: Static air cushion; 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 Names: Roho air cushion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1a. Change in peak pressure (mmHg) applied to the skin of the buttock and posterior thighs	The X3 Medical Wheelchair Seat pressure mapping system will record the peak pressure (mmHg) at the interface between the buttock and posterior thighs and the cushion when the participant is sitting and reaching on the two wheelchair cushions.	64 minutes
1b. Change in peak pressure duration (mmHg) applied to the skin of the buttock and posterior thighs	The X3 Medical Wheelchair Seat pressure mapping system will record the duration (seconds) of peak pressure amount (mmHg) at the interface between the buttock and posterior thighs and the cushion when the participant is sitting and reaching on the two wheelchair cushions.	64 minutes
1c. Change in mean pressure (mmHg) applied to the skin of the buttock and posterior thighs	The X3 Medical Wheelchair Seat pressure mapping system will record the mean pressure (mmHg) at the interface between the buttock and posterior thighs and the cushion when the participant is sitting and reaching on the two wheelchair cushions.	64 minutes
1d. Change in peak pressure index	The X3 Medical Wheelchair Seat pressure mapping system will record the peak pressure index is defined as how evenly the pressure is distributed; the lower this value, the more evenly the pressures are distributed.	64 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin responses to the cushion interface pressure	After sitting on each of the two cushions, visual skin examinations will record if the skin becomes pink, red, or blanches due to pressure caused by sitting or actively moving on the cushion and how long (seconds/minutes) it takes for the skin issue to resolve	10 minutes
Observation of postural stability	The therapist investigator will use a Likert scale to record the participant's postural stability while sitting and reaching on each of the two wheelchair cushions. Likert scale is anchored by "poor posture-near fall" and "upright stable posture"	Monitored over 64 minutes duration; scored at least twice during the static & active conditions.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Pressure injury risk assessment tool	The Braden scale is frequently used by therapists to score an individuals risk for developing a pressure sore. Scored risk factors include: Sensory perception, moisture, activity level, mobility, nutrition, friction and shear using a 1-4 point scale with a maximum score of 23 points. Risk is then categorized into severe, high, moderate, mild and zero risk for predicting pressure sores.	10 minutes
Exploratory: Buttock and bilateral posterior thigh sensation	Light touch (cotton ball) and pin prick (wooden cotton tip applicator) sensation at 13 locations in the buttock and posterior thigh areas for both sides of the body will be recorded using a modified version of the American Spinal Injury Association (ASIA) sensory examination. Scores include 0 (absent), 1 (impaired), 2 (normal).	15 minutes
Exploratory: Participant's report of comfort while sitting on the cushions	Survey questions ask the participant to a) rank order the two cushions as to comfort, b) indicate (yes/no) if the cushion was comfortable and reply with open-ended comments.	5 minutes
Exploratory: Participant's report of ease of transfer both while transferring to and from the wheelchair cushions	Survey questions ask the participant to a) rank order the two cushions as to how easy it is to transfer onto and off of each cushion, b) indicate (yes/no) if each cushion was difficult to transfer onto/off of, and reply with open-ended comments	5 minutes
Exploratory: Participant's report of postural stability	Survey questions ask the participant to a) rank order the two cushions as to how stable was their posture while sitting on each cushion, b) indicate (yes/no) if he/she felt unstable, experienced a feeling of loss of balance while statically sitting or reaching, and reply with open-ended comments.	5 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: JRD Enterprises LLC; Michigan Corporate Relations Network Small Company Innovation Program
• Investigators: Principal Investigator: Cathy A Larson, Ph.D., University of Michigan-Flint

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: wheelchair cushion; pressure mapping; pressure wounds
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: HUM00139020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No