Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT07029802

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

No intervention

Study Details

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

Study ID

NCT07029802

Start date

Nov 18, 2024

Status verified date

Jun, 2026

Completion date

Jun 15, 2027

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with SCI

Uninjured participants

Interventions

No intervention

This is an observational study

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-06-18.