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

NCT03987243 | Completed

• 2 other identifiers: 16-0075311R21AG050640-01A1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Seating Pressure Mapping; Pressure Injury Prevention; Seating Interface Pressure; Wheelchair User

Outcome Measures

Primary Outcomes (1)

• Trunk Movement

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

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Intervention

OTHER

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; Other: Mobile Seat Interface Pressure Mapping System (IPM)

Interventions

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.

Intervention

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

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Documented active pressure ulcer of any stage at initiation of study

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Minnesota: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (34)

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• Vos-Draper TL, Morrow MMB, Ferguson JE, Mathiowetz VG. Effects of Real-Time Pressure Map Feedback on Confidence in Pressure Management in Wheelchair Users With Spinal Cord Injury: Pilot Intervention Study. JMIR Rehabil Assist Technol. 2023 Oct 12;10:e49813. doi: 10.2196/49813.

  PMID: 37824188 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Melissa MB Morrow, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Tamara L Vos-Draper, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: February 14, 2017
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2017
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)