CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Structured Pressure Ulcer Prevention Education +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03987243
NCT03987243N/ACompleted

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

Mayo Clinic·interventional·Posted Jun 14, 2019·Updated Jun 14, 2019

In Brief

A clinical study evaluating Structured Pressure Ulcer Prevention Education and Mobile Seat Interface Pressure Mapping System (IPM) for Spinal Cord Injuries. Completed, enrolled 19 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2019
Enrollment StartFeb 14, 2017
Primary CompletionSep 11, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.0 years ago

Interventions

Structured Pressure Ulcer Prevention Educationbehavioral

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.

Mobile Seat Interface Pressure Mapping System (IPM)other

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