Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT07237035
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reclaiming Independence: Daily Activities and Rehabilitation Goals in 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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Importance of Activities of Daily Living (ADLs) Assessed by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline', 'description': "The primary outcome is the quantitative score representing the perceived importance of 10 specific Activities of Daily Living (ADLs) (e.g., Eating, Bathing, Transfer, Wheelchair Use) . Participants will rate each ADL using an 11-point Visual Analog Scale (VAS) , where 0 represents 'Not important at all' and 10 represents 'Extremely important' . The mean VAS score for each ADL will be calculated to identify the patient's functional priorities. This data will be collected via the custom-designed Activities of Daily Living Importance (ADLI) Survey ."}], 'secondaryOutcomes': [{'measure': 'Targeted Independence Level for ADLs', 'timeFrame': 'Baseline', 'description': "Assessment of the participant's stated personal rehabilitation goals for the same 10 ADLs. Goals are categorized using a 4-level nominal scale: Complete Independence, Modified Independence (with device), Dependent on a Person (with assistance), or Total Dependence . The frequency and distribution of targeted goals for each ADL will be analyzed."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries (SCI)']}, 'referencesModule': {'references': [{'pmid': '32879577', 'type': 'BACKGROUND', 'citation': 'Agarwal P, Mishra AN, Sudesh W, Prachir M, Dhananjaya S. Priorities of desired functional recovery in Indian spinal cord injury patients. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):896-899. doi: 10.1016/j.jcot.2019.08.001. Epub 2019 Aug 1.'}, {'pmid': '39060481', 'type': 'BACKGROUND', 'citation': 'Ullah S, Qureshi AZ, AlWehaibi TA, Rathore FA, Sami W, Ayaz SB, AlKeid NH, Alibrahim MS, AlHabter AM, Alketheeri WB, Bashir MS. Functional priorities of individuals with spinal cord injury: a Saudi Arabian perspective. Spinal Cord. 2024 Sep;62(9):539-545. doi: 10.1038/s41393-024-01018-0. Epub 2024 Jul 26.'}, {'pmid': '18209742', 'type': 'BACKGROUND', 'citation': 'Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal Cord. 2008 Jul;46(7):500-6. doi: 10.1038/sj.sc.3102172. Epub 2008 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this cross-sectional, observational survey was to assess the importance individuals with Spinal Cord Injury (SCI) in Türkiye place on specific Activities of Daily Living (ADL) and their target levels of independence for these activities after rehabilitation. The primary question it aims to answer is:\n\nWhat are the functional priorities of individuals with SCI (e.g., eating, bathing, walking, wheelchair use), and what are their personal goals for independence in these activities?\n\nParticipants will complete a two-part questionnaire (at Biruni University Hospital) regarding the importance of ADL and independence goals.', 'detailedDescription': "This study is a cross-sectional, single-center, observational study designed to address a recognized gap in rehabilitation literature concerning person-centered care in Spinal Cord Injury (SCI) . While aligning treatment with patient-specific goals is critical for improving motivation and adherence, most research identifying patient functional priorities has been conducted in Western populations . This research specifically aims to investigate these priorities within the Turkish SCI population, for which currently no data is available, thereby providing a foundation for culturally-relevant and patient-specific rehabilitation planning . The study will be conducted at the Biruni University Hospital Physical Medicine and Rehabilitation inpatient and outpatient clinics .\n\nParticipants and Data Collection The target sample size is 92 participants . This sample size was determined by a power analysis using G\\*Power ver 3.1.9.4, calculated to achieve 90% power to detect a medium effect size (0.3) for correlation tests at an alpha level of 0.05 . Participants will complete a custom-designed two-part survey. In addition to the survey responses, relevant clinical and demographic data will be collected.\n\nSurvey Instrument: Activities of Daily Living Importance (ADLI) Survey The primary data collection tool is the custom-designed, two-part ADLI Survey. The ADL items were selected based on their relevance to the rehabilitation framework for SCI patients, covering self-care, mobility, and essential functional tasks.\n\nPart 1: Functional Importance Assessment: This section assesses the patient's perceived importance of 10 key ADLs. Participants rate the significance of each ADL using an 11-point Visual Analog Scale (VAS) ranging from 0 (Not important at all) to 10 (Extremely important). The ADLs assessed include Eating, Bathing, Clean Intermittent Catheterization (Bladder emptying), Dressing, Oral/Face Care (Grooming), Sitting, Walking, Wheelchair Use, Transferring, and Sexual Activity.\n\nPart 2: Targeted Independence Goal: This section evaluates the participant's personal rehabilitation goal for the same 10 ADLs. For each activity, patients select one of four mutually exclusive independence levels, reflecting realistic outcomes often targeted in a rehabilitation program: Can do independently (Complete Independence), Can do with an assistive device (Modified Independence), Can do with personal assistance (Dependent on a person), or Will remain dependent in this activity (Total Dependence).\n\nStatistical Analysis: Data analysis will be performed using SPSS ver 18.0 . The normality of data distribution will be assessed using the Shapiro-Wilk test . Descriptive statistics will be presented as mean (Standard Deviation) for normally distributed data, median (Interquartile Range) for non-normally distributed data, and frequencies/percentages for categorical variables . Relationships between categorical variables will be analyzed using the Chi-square or Fischer's exact test . For inter-group comparisons, Independent sample t-tests and One-Way ANOVA will be used for parametric data, while Kruskal-Wallis and Mann-Whitney U tests will be used for non-parametric data . A significance level of p \\< 0.05 will be adopted ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The source population for this observational, cross-sectional study is the adult patient population with Spinal Cord Injury (SCI), both traumatic and non-traumatic, receiving care at a single-center academic setting in Turkey. Specifically, participants will be recruited from the inpatient and outpatient clinics of the Physical Medicine and Rehabilitation Department at Biruni University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients aged 18-60\n* Tetraplegic or paraplegic due to spinal cord injury\n* At least 1 month has passed since the rehabilitation period\n* Patients who agree to participate in the study and provide written consent\n\nExclusion Criteria:\n\n* Having a disability due to any previous neurological (stroke, MS, Parkinson's, etc.) or orthopedic (amputation, knee prosthesis, etc.) reasons\n* Insufficient mental functions to answer all questions"}, 'identificationModule': {'nctId': 'NCT07237035', 'briefTitle': 'Reclaiming Independence: Daily Activities and Rehabilitation Goals in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Reclaiming Independence: The Role of Activities of Daily Living and the Goal of Functional Rehabilitation in Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'MedipolIU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Spinal Cord Injury', 'description': 'This observational group consists of 92 adults (aged 18-60) with Spinal Cord Injury (SCI) (either traumatic or non-traumatic, paraplegia or tetraplegia) . Participants are recruited from the Biruni University Physical Medicine and Rehabilitation clinics .'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Mücahit Atasoy, Asst. Prof.', 'role': 'CONTACT', 'email': 'dr.mucahitatasoy@gmail.com', 'phone': '+905552855696'}], 'overallOfficials': [{'name': 'Evrim Coşkun, MD Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 3 years following article publication.', 'ipdSharing': 'YES', 'description': "De-identified individual participant data (IPD), including all demographic, clinical, and primary/secondary outcome measures (VAS scores for ADL importance and targeted independence levels), will be shared with qualified researchers. The sharing period will commence 9 months after article publication and conclude 3 years thereafter. Data access requests must be accompanied by a methodologically sound proposal and will be granted upon the corresponding author's approval and the execution of a Data Use Agreement (DUA) to strictly ensure confidentiality and adherence to ethical guidelines.", 'accessCriteria': 'Qualified researchers who submit a methodologically sound proposal for achieving the goals of the approved proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst Prof', 'investigatorFullName': 'Mucahit Atasoy, MD', 'investigatorAffiliation': 'Medipol University'}}}}