Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury

NCT ID: NCT07029802

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2027-06-15

Brief Summary

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The purpose of this study is twofold: (1) Develop a new evaluation scale for mental body representations (MBR, i.e., body awareness and visuospatial body maps) for adults with spinal cord injury (SCI) with and without neuropathic pain. (2) Assess the psychometric properties of usability, reliability, and validity of the new evaluation scale This is a cross-sectional observational study design. For Aim 1, this study will involve initial item generation for a novel MBR evaluation scale for SCI through email communication, and individual interviews proctored remotely through Zoom, or, if preferred by the participant, in-person. For Aim 2, the study will include a Zoom call for consenting and questionnaires, as well as an in-person visit where participants will be tested with the new SCI-BodyMap evaluation scale, and a questionnaire asking about the usability and satisfaction of the new evaluation scale.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with SCI

No intervention

Intervention Type OTHER

This is an observational study

Uninjured participants

No intervention

Intervention Type OTHER

This is an observational study

Interventions

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No intervention

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Control group

* Uninjured adults (from the contact list with the Brain Body Mind lab or through fliers or StudyFinder)
* 18+ years old adults

SCI group

* 18+ years old, participants with an incomplete or complete SCI of ≥ 1 year
* medically stable
* able to read and understand English
* having access to the internet/iPad/computer/phone and willing to come in for an in-person testing at the University of Minnesota.

Exclusion Criteria

SCI group

* Uncontrolled seizure disorder;
* cognitive impairment and/or communicative disability (e.g., due to brain injury) preventing them from following directions or from learning;
* ventilator dependency;
* major medical complications;
* pressure ulcers hindering prolonged sitting or lying down.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Van de Winckel

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sydney Carpentier

Role: CONTACT

562-508-9693

Facility Contacts

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Sydney Carpentier

Role: primary

562-508-9693

Other Identifiers

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PMR-2023-32512

Identifier Type: -

Identifier Source: org_study_id

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