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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Structured Pressure Ulcer Prevention Education; Other: Mobile Seat Interface Pressure Mapping System (IPM)

• Registration Number: NCT03987243
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2017-02-14
• Primary Completion: 2017-09-11
• Study Completion: 2017-09-11
• Status Verified: 2019-06
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Study First Posted: 2019-06-14
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Structured Pressure Ulcer Prevention Education	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	Mobile Seat Interface Pressure Mapping System (IPM)	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.

Primary Outcome Measures

Name	Time	Method
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.	The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.

Secondary Outcome Measures

Name	Time	Method
Total Vector Magnitude of 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.	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	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 will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States