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Trial record 6 of 25 for:    Injuries | Spinal Cord Injuries | ( Map: Minnesota, United States )

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
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Melissa M. Morrow, Ph.D., 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).

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

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.


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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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Melissa MB Morrow, PhD Mayo Clinic
Principal Investigator: Tamara L Vos-Draper, PhD University of Minnesota - Clinical and Translational Science Institute
  Study Documents (Full-Text)

Documents provided by Melissa M. Morrow, Ph.D., Mayo Clinic:

Additional Information:
Publications:

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Responsible Party: Melissa M. Morrow, Ph.D., Associate Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03987243     History of Changes
Other Study ID Numbers: 16-007531
1R21AG050640-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa M. Morrow, Ph.D., Mayo Clinic:
Spinal Cord Injury
Seating Pressure Mapping
Pressure Injury Prevention
Seating Interface Pressure
Wheelchair User
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System