NCT07029802 · University of Minnesota
Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury
What this study is about
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.
View original scientific description
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
OTHER
No intervention
This is an observational study
Primary outcome measures
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.
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).
establish the minimal detectable difference (MDD)
Time frame: 1 week
The Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations