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Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured Pressure Ulcer Prevention Education
Mobile Seat Interface Pressure Mapping System (IPM)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Seating Pressure Mapping, Pressure Injury Prevention, Seating Interface Pressure, Wheelchair User

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment)
  • Individuals who use a wheelchair as their primary form of mobility
  • Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN

Exclusion Criteria:

  • Documented active pressure ulcer of any stage at initiation of study

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Two interventions will be provided. The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study. The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases.

Outcomes

Primary Outcome Measures

Trunk Movement
The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.

Secondary Outcome Measures

Total Vector Magnitude of Movement
The vector magnitude for each second of data during wear-times will be classified as a period of activity or inactivity.
Forward and Lateral Tilt
Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes

Full Information

First Posted
June 11, 2019
Last Updated
June 13, 2019
Sponsor
Mayo Clinic
Collaborators
University of Minnesota, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03987243
Brief Title
Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
Official Title
Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
September 11, 2017 (Actual)
Study Completion Date
September 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Minnesota, National Institute on Aging (NIA)

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
This study will examine two interventions to increase weight shifts, overall trunk movement, and self-efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI).
Detailed Description
Participants will use a mobile seat interface pressure mapping system that gives them live, real-time, visual feedback on the distribution of pressure between them and their seat cushion. This type of feedback works as a compensatory strategy for lack of sensation and allows the individual to visually observe pressure distribution they are not able to feel. Additionally, the participants will be provided with structured pressure ulcer prevention education, grounded in the principles of social cognitive theory, regarding pressure ulcer risk and use of weight shifts. The pressure mapping system, which will be used during training, provides virtual modeling of the desired outcome (reduced pressure) and is an important part of the education module. The findings of this study will inform clinicians and investigators of whether use of mobile seat interface pressure mapping as a compensatory-based intervention has a positive impact on trunk movement and self-efficacy for completing weight shifts in wheelchair users who lack sensation. Another contribution of this work is an exploration of the relationship between self-efficacy and movement in wheelchair users.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injury, Seating Pressure Mapping, Pressure Injury Prevention, Seating Interface Pressure, Wheelchair User

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a longitudinal, within-subject, repeated (A-B-A-B) measures design. Two interventions will be provided: structured education regarding pressure ulcer prevention through weight shifts at start of study and use of a mobile seat interface pressure map (IPM).
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Two interventions will be provided. The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study. The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases.
Intervention Type
Behavioral
Intervention Name(s)
Structured Pressure Ulcer Prevention Education
Intervention Description
Structured education for performance weight shift maneuvers and pressure ulcer prevention will occur during the initial visit for each subject. The education method used aligns with principles of the social cognitive theory to facilitate learning. The purpose in providing the education is to ensure all of the participants receive uniform instruction in how to perform weight shifts and to facilitate understanding of the importance of completing them as a protective measure against pressure ulcer development. Because each participant will come into the study at varying levels of understanding about pressure ulcer risk and knowledge of how to complete weight shift maneuvers, the education component is critical to ensure all participants are provided with the same information in the same way.
Intervention Type
Other
Intervention Name(s)
Mobile Seat Interface Pressure Mapping System (IPM)
Intervention Description
This mobile IPM system was designed to provide visual information about seat interface pressure distribution to compensate for lack of sensation on the sitting surface. This variable will be toggled on and off between the intervention and control phases of the study. The participants will have access to the visual feedback while learning how to complete weight shift maneuvers at the initial visit and then again at home during the intervention phases (weeks 2 and 4). During the control phases (weeks 1 and 3), they will not have access to the visual feedback from the pressure map
Primary Outcome Measure Information:
Title
Trunk Movement
Description
The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.
Time Frame
For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Secondary Outcome Measure Information:
Title
Total Vector Magnitude of Movement
Description
The vector magnitude for each second of data during wear-times will be classified as a period of activity or inactivity.
Time Frame
For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Title
Forward and Lateral Tilt
Description
Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes
Time Frame
For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment) Individuals who use a wheelchair as their primary form of mobility Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN Exclusion Criteria: Documented active pressure ulcer of any stage at initiation of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa MB Morrow, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamara L Vos-Draper, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI

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