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NCT Number: NCT07029802

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

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.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Sydney Carpentier

CONTACT

[email protected]

562-508-9693

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

  1. Reliability of the scale

    Time frame: 1 week

    Inter-rater reliability of the new SCI-BodyMap scale (scores from two physical or occupational therapists testing the same participants) will be evaluated with Kappa and ICC.

  2. Validity of the scale

    Time frame: 1 week

    Convergent validity of the newly developed SCI-BodyMap scale for SCI will be tested with Spearman rho correlations between the new MBR scale and the Revised Body awareness scale, Multidimensional Assessment lnteroceptive Awareness-2 (MAIA- 2), lowest, average and highest neuropathic pain levels with the Numeric Pain Rating Scale (NPRS), and the NINOS-COE SCI Functional lndex/Assistive Technology Scale (SCI/Fl-AT).

  3. establish the minimal detectable difference (MDD)

    Time frame: 1 week

    The Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.

Secondary outcomes

  1. QQ-10 scale, to assess the usability of the new MBR scale.

    Time frame: 1 week

    This will be complemented by open-ended questions about the scale from the point of view of the participant with SCI and the therapists who evaluated the participant with the new scale.

  2. SCI-related symptoms (Penn Spasm Frequency Scale

    Time frame: 1 week

    We will assess the frequency and severity of spasms (Penn Spasm Frequency Scale),

  3. SCI-related symptoms (BARQ-R)

    Time frame: 1 week

    We will assess body awareness related to the participant's perception of tension in the body (BARQ-R)

  4. SCI-related symptoms (MAIA-2)

    Time frame: 1 week

    We will assess interoceptive awareness (MAIA-2).

  5. Physical functioning.

    Time frame: 1 week

    We will measure function related to basic mobility, self-care, fine motor function, and ambulation (NINOS-COE SCI/Fl-AT)

Study contacts

Contact information is provided by the study sponsor or research team.

Sydney Carpentier

CONTACT

[email protected]

562-508-9693

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Jun 18, 2026

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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