Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03987243|
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: Structured Pressure Ulcer Prevention Education Other: Mobile Seat Interface Pressure Mapping System (IPM)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI|
|Actual Study Start Date :||February 14, 2017|
|Actual Primary Completion Date :||September 11, 2017|
|Actual Study Completion Date :||September 11, 2017|
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
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.
Other: Mobile Seat Interface Pressure Mapping System (IPM)
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
- 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. ]The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.
- Total Vector Magnitude of 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. ]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 [ 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. ]Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987243
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Melissa MB Morrow, PhD||Mayo Clinic|
|Principal Investigator:||Tamara L Vos-Draper, PhD||University of Minnesota - Clinical and Translational Science Institute|