Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT07029802
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the scale', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Validity of the scale', 'timeFrame': '1 week', 'description': '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).'}, {'measure': 'establish the minimal detectable difference (MDD)', 'timeFrame': '1 week', 'description': 'The Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.'}], 'secondaryOutcomes': [{'measure': 'QQ-10 scale, to assess the usability of the new MBR scale.', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'SCI-related symptoms (Penn Spasm Frequency Scale', 'timeFrame': '1 week', 'description': 'We will assess the frequency and severity of spasms (Penn Spasm Frequency Scale),'}, {'measure': 'SCI-related symptoms (BARQ-R)', 'timeFrame': '1 week', 'description': "We will assess body awareness related to the participant's perception of tension in the body (BARQ-R)"}, {'measure': 'SCI-related symptoms (MAIA-2)', 'timeFrame': '1 week', 'description': 'We will assess interoceptive awareness (MAIA-2).'}, {'measure': 'Physical functioning.', 'timeFrame': '1 week', 'description': 'We will measure function related to basic mobility, self-care, fine motor function, and ambulation (NINOS-COE SCI/Fl-AT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nControl group\n\n* Uninjured adults (from the contact list with the Brain Body Mind lab or through fliers or StudyFinder)\n* 18+ years old adults\n\nSCI group\n\n* 18+ years old, participants with an incomplete or complete SCI of ≥ 1 year\n* medically stable\n* able to read and understand English\n* having access to the internet/iPad/computer/phone and willing to come in for an in-person testing at the University of Minnesota.\n\nExclusion Criteria:\n\nSCI group\n\n* Uncontrolled seizure disorder;\n* cognitive impairment and/or communicative disability (e.g., due to brain injury) preventing them from following directions or from learning;\n* ventilator dependency;\n* major medical complications;\n* pressure ulcers hindering prolonged sitting or lying down.'}, 'identificationModule': {'nctId': 'NCT07029802', 'briefTitle': 'Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'PMR-2023-32512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with SCI', 'interventionNames': ['Other: No intervention']}, {'label': 'Uninjured participants', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is an observational study', 'armGroupLabels': ['Participants with SCI', 'Uninjured participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sydney Carpentier', 'role': 'CONTACT', 'email': 'carpe749@umn.edu', 'phone': '562-508-9693'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Sydney Carpentier', 'role': 'CONTACT', 'email': 'carpe749@umn.edu', 'phone': '562-508-9693'}], 'overallOfficials': [{'name': 'Ann Van de Winckel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}