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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Structured Pressure Ulcer Prevention Education
* Other: Mobile Seat Interface Pressure Mapping System (IPM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>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. | Behavioral: Structured Pressure Ulcer Prevention Education<br>* 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.<br>Other: Mobile Seat Interface Pressure Mapping System (IPM)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk Movement | The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Seating Pressure Mapping, Pressure Injury Prevention, Seating Interface Pressure, Wheelchair User