Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07029802
Enrollment
80
Registered
2025-06-19
Start date
2024-11-18
Completion date
2027-06-15
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

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.

Interventions

OTHERNo intervention

This is an observational study

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Reliability of the scale1 weekInter-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.
Validity of the scale1 weekConvergent 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).
establish the minimal detectable difference (MDD)1 weekThe Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.

Secondary

MeasureTime frameDescription
QQ-10 scale, to assess the usability of the new MBR scale.1 weekThis 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.
SCI-related symptoms (Penn Spasm Frequency Scale1 weekWe will assess the frequency and severity of spasms (Penn Spasm Frequency Scale),
SCI-related symptoms (BARQ-R)1 weekWe will assess body awareness related to the participant's perception of tension in the body (BARQ-R)
SCI-related symptoms (MAIA-2)1 weekWe will assess interoceptive awareness (MAIA-2).
Physical functioning.1 weekWe will measure function related to basic mobility, self-care, fine motor function, and ambulation (NINOS-COE SCI/Fl-AT)

Countries

United States

Contacts

CONTACTSydney Carpentier
carpe749@umn.edu562-508-9693
PRINCIPAL_INVESTIGATORAnn Van de Winckel

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026