Reclaiming Independence: Daily Activities and Rehabilitation Goals in Spinal Cord Injury

NCT ID: NCT07237035

Last Updated: 2025-11-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-03

Study Completion Date

2026-01-15

Brief Summary

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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:

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.

Detailed Description

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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 .

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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Spinal Cord Injuries (SCI)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

* Male and female patients aged 18-60
* 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

* Having a disability due to any previous neurological (stroke, MS, Parkinson's, etc.) or orthopedic (amputation, knee prosthesis, etc.) reasons
* Insufficient mental functions to answer all questions
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Mucahit Atasoy, MD

Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mücahit Atasoy, Asst. Prof.

Role: CONTACT

+905552855696

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.

Reference Type BACKGROUND
PMID: 32879577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39060481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18209742 (View on PubMed)

Other Identifiers

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MedipolIU

Identifier Type: -

Identifier Source: org_study_id

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