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Completed

NCT Number: NCT03987243

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

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).

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Pressure Ulcer Prevention Education

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of Minnesota

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2019
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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