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Wheelchair Cushion Comparison Study: SAFETY

Primary Purpose

Spinal Cord Injuries, Stroke, Healthy Adults

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alternating air wheelchair cushion
Static air cushion
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring wheelchair cushion, pressure mapping, pressure wounds

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan - Flint

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Alternating air then static air cushion

Static air then alternating air cushion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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
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"

Full Information

First Posted
January 19, 2018
Last Updated
August 31, 2021
Sponsor
University of Michigan
Collaborators
JRD Enterprises LLC, Michigan Corporate Relations Network Small Company Innovation Program
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1. Study Identification

Unique Protocol Identification Number
NCT03430375
Brief Title
Wheelchair Cushion Comparison Study: SAFETY
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
JRD Enterprises LLC, Michigan Corporate Relations Network Small Company Innovation Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Stroke, Healthy Adults
Keywords
wheelchair cushion, pressure mapping, pressure wounds

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternating air then static air cushion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Static air then alternating air cushion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Alternating air wheelchair cushion
Other Intervention Name(s)
Ease alternating air wheelchair cushion
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Static air cushion
Other Intervention Name(s)
Roho air cushion
Intervention Description
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.
Primary Outcome Measure Information:
Title
1a. Change in peak pressure (mmHg) applied to the skin of the buttock and posterior thighs
Description
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.
Time Frame
64 minutes
Title
1b. Change in peak pressure duration (mmHg) applied to the skin of the buttock and posterior thighs
Description
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.
Time Frame
64 minutes
Title
1c. Change in mean pressure (mmHg) applied to the skin of the buttock and posterior thighs
Description
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.
Time Frame
64 minutes
Title
1d. Change in peak pressure index
Description
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.
Time Frame
64 minutes
Secondary Outcome Measure Information:
Title
Change in skin responses to the cushion interface pressure
Description
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
Time Frame
10 minutes
Title
Observation of postural stability
Description
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"
Time Frame
Monitored over 64 minutes duration; scored at least twice during the static & active conditions.
Other Pre-specified Outcome Measures:
Title
Exploratory: Pressure injury risk assessment tool
Description
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.
Time Frame
10 minutes
Title
Exploratory: Buttock and bilateral posterior thigh sensation
Description
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).
Time Frame
15 minutes
Title
Exploratory: Participant's report of comfort while sitting on the cushions
Description
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.
Time Frame
5 minutes
Title
Exploratory: Participant's report of ease of transfer both while transferring to and from the wheelchair cushions
Description
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
Time Frame
5 minutes
Title
Exploratory: Participant's report of postural stability
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy A Larson, Ph.D.
Organizational Affiliation
University of Michigan-Flint
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan - Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Wheelchair Cushion Comparison Study: SAFETY

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