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

NCT07029802 | Recruiting

• 1 other identifier: PMR-2023-32512
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• Reliability of the scale

  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.

  1 week

• Validity of the scale

  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).

  1 week

• establish the minimal detectable difference (MDD)

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

  1 week

Secondary Outcomes (5)

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

  1 week

• SCI-related symptoms (Penn Spasm Frequency Scale

  1 week

• SCI-related symptoms (BARQ-R)

  1 week

• SCI-related symptoms (MAIA-2)

  1 week

• Physical functioning.

  1 week

Study Arms (2)

Participants with SCI

Other: No intervention

Uninjured participants

Other: No intervention

Interventions

No intervention OTHER

This is an observational study

Participants with SCI; Uninjured participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For all adults with SCI in this study: 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.

You may qualify if:

• Control group
• Uninjured adults (from the contact list with the Brain Body Mind lab or through fliers or StudyFinder)
• + years old adults
• SCI group
• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

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

• Ann Van de Winckel

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Carpentier

CONTACT

562-508-9693; carpe749@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 19, 2025
• Study Start: November 18, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)