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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Uninjured adults (from the contact list with the Brain Body Mind lab or through fliers or StudyFinder)

18+ years old adults

18+ years old, participants with an incomplete or complete SCI of ≥ 1 year

medically stable

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    This is an observational study

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Participants with SCI1 intervention
Group B: Uninjured participants1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 week
2

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).

Time frame
1 week
3

establish the minimal detectable difference (MDD)

The Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.

Time frame
1 week

Secondary outcomes

1

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.

Time frame
1 week
2

SCI-related symptoms (Penn Spasm Frequency Scale

We will assess the frequency and severity of spasms (Penn Spasm Frequency Scale),

Time frame
1 week
3

SCI-related symptoms (BARQ-R)

We will assess body awareness related to the participant's perception of tension in the body (BARQ-R)

Time frame
1 week
4

SCI-related symptoms (MAIA-2)

We will assess interoceptive awareness (MAIA-2).

Time frame
1 week

Other outcomes

Sponsors and contacts

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