Wheelchair Cushion Comparison Study: SAFETY

NCT03430375 | Completed

• 1 other identifier: HUM00139020
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Stroke; Healthy Adults

Keywords

wheelchair cushion; pressure mapping; pressure wounds

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in skin responses to the cushion interface pressure

  10 minutes

• Observation of postural stability

  Monitored over 64 minutes duration; scored at least twice during the static & active conditions.

Other Outcomes (5)

• Exploratory: Pressure injury risk assessment tool

  10 minutes

• Exploratory: Buttock and bilateral posterior thigh sensation

  15 minutes

• Exploratory: Participant's report of comfort while sitting on the cushions

  5 minutes

Study Arms (2)

Alternating air then static air cushion

ACTIVE COMPARATOR

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; Device: Static air cushion

Static air then alternating air cushion

ACTIVE COMPARATOR

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; Device: Static air cushion

Interventions

Alternating air wheelchair cushion DEVICE

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.

Also known as: Ease alternating air wheelchair cushion

Alternating air then static air cushion; Static air then alternating air cushion

Static air cushion DEVICE

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.

Also known as: Roho air cushion

Alternating air then static air cushion; Static air then alternating air cushion

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• JRD Enterprises LLC: collaborator
• Michigan Corporate Relations Network Small Company Innovation Program: collaborator

Study Sites (1)

University of Michigan - Flint

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cathy A Larson, Ph.D.

  University of Michigan-Flint

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 12, 2018
• Study Start: May 31, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)