Reclaiming Independence: Daily Activities and Rehabilitation Goals in Spinal Cord Injury
NCT ID: NCT07237035
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
92 participants
OBSERVATIONAL
2025-11-03
2026-01-15
Brief Summary
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What 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?
Participants will complete a two-part questionnaire (at Biruni University Hospital) regarding the importance of ADL and independence goals.
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Detailed Description
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Participants 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.
Survey 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.
Part 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.
Part 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).
Statistical 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 .
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Patients with Spinal Cord Injury
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 .
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Tetraplegic or paraplegic due to spinal cord injury
* At least 1 month has passed since the rehabilitation period
* Patients who agree to participate in the study and provide written consent
Exclusion Criteria
* Insufficient mental functions to answer all questions
18 Years
60 Years
ALL
No
Sponsors
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Medipol University
OTHER
Responsible Party
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Mucahit Atasoy, MD
Asst Prof
Principal Investigators
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Evrim Coşkun, MD Prof
Role: STUDY_CHAIR
Başakşehir Çam & Sakura City Hospital
Locations
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Biruni University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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MedipolIU
Identifier Type: -
Identifier Source: org_study_id
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