Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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]
- Validity of the scale [Time frame: 1 week]
- establish the minimal detectable difference (MDD) [Time frame: 1 week]
Secondary outcome measures (5)
- QQ-10 scale, to assess the usability of the new MBR scale. [Time frame: 1 week]
- SCI-related symptoms (Penn Spasm Frequency Scale [Time frame: 1 week]
- SCI-related symptoms (BARQ-R) [Time frame: 1 week]
- SCI-related symptoms (MAIA-2) [Time frame: 1 week]
- Physical functioning. [Time frame: 1 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT07029802 · PMR-2023-32512