Spinal Cord InjuriesNCT07029802
Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Sydney Carpentier, 562-508-9693, carpe749@umn.edu
About this study
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
- Being tested
- No intervention
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Participants with SCI | Not described Receives: Other: No intervention | |
| Uninjured participants | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1 week
establish the minimal detectable difference (MDD)
The Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.
Measured: 1 week
Secondary outcomes (5)
QQ-10 scale, to assess the usability of the new MBR scale.
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.
Measured: 1 week
SCI-related symptoms (Penn Spasm Frequency Scale
We will assess the frequency and severity of spasms (Penn Spasm Frequency Scale),
Measured: 1 week
SCI-related symptoms (BARQ-R)
We will assess body awareness related to the participant's perception of tension in the body (BARQ-R)
Measured: 1 week
SCI-related symptoms (MAIA-2)
We will assess interoceptive awareness (MAIA-2).
Measured: 1 week
Physical functioning.
We will measure function related to basic mobility, self-care, fine motor function, and ambulation (NINOS-COE SCI/Fl-AT)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start18 Nov 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029802
- Sponsor's protocol ID
- PMR-2023-32512
- Status last verified
- Jun 2026
- First submitted
- 30 May 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07029802
- Acronym / sponsor ID
- PMR-2023-32512
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with SCI | – | Other: No intervention |
| Uninjured participants | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study | Other | Participants with SCI, Uninjured participants |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Van de Winckel principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney Carpentier (562-508-9693, carpe749@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the scale (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.