Spinal Cord Injuries (SCI)NCT07237035
Reclaiming Independence: Daily Activities and Rehabilitation Goals in Spinal Cord Injury
An observational study of Spinal Cord Injuries (SCI), run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 15 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Male and female patients aged 18-60
- Tetraplegic or paraplegic due to spinal cord injury
- At least 1 month has passed since the rehabilitation begining
- Patients who agree to participate in the study and provide written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reclaiming Independence: Importance of Activities of Daily Living and Rehabilitation Objectives in Spinal Cord Injury Patients in Türkiye
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.
Read the detailed description
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 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) Questionnaire The primary data collection tool is the custom-designed, two-part ADLI Questionnaire. 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 10-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: Assessment of Independence Goals: The second part of the survey assessed the participants' targeted post-rehabilitation independence levels for the specified 10 ADLs. Participants selected one of four mutually exclusive categories that reflect standard rehabilitation outcomes:
- Complete Independence (can perform without help),
- Modified Independence (requires an assistive device),
- Assisted (requires personal assistance),
- Total Dependence (unable to perform the activity).
Statistical Analysis: The data were analyzed using the SPSS Statistics 22.0 program. The normality of continuous variables was assessed using the Shapiro-Wilk test. For variables showing a normal distribution, independent samples t-tests and one-way ANOVA were used for group comparisons. For data that did not show a normal distribution, the Mann-Whitney U and Kruskal-Wallis tests were applied. The chi-square test was used for the analysis of categorical data; the Fisher exact test was used when the test conditions could not be met. The statistical significance level was set at p<0.05.
- Conditions
- Spinal Cord Injuries (SCI)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Spinal Cord Injury | This observational group consists of 56 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Importance of Activities of Daily Living (ADLs) Assessed by Visual Analog Scale (VAS)
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 10-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) Questionnaire.
Measured: Baseline
Secondary outcomes (1)
Post-Rehabilitation İndependence Goals for ADLs
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 (can perform without help), Modified Independence (requires an assistive device), Assisted (requires personal assistance), Total Dependence (unable to perform the activity).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start3 Nov 2025
- Primary completion3 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mucahit Atasoy, MD, Medipol University
- Investigators
- Evrim Coşkun, MD Prof, Study chair, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237035
- Sponsor's protocol ID
- MedipolIU
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32879577Ullah 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.
PubMed 39060481Ditunno 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.
PubMed 18209742
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reclaiming Independence: Importance of Activities of Daily Living and Rehabilitation Objectives in Spinal Cord Injury Patients in Türkiye
- ClinicalTrials.gov ID
- NCT07237035
- Acronym / sponsor ID
- MedipolIU
- Conditions
- Spinal Cord Injuries (SCI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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) Questionnaire The primary data collection tool is the custom-designed, two-part ADLI Questionnaire. 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 10-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: Assessment of Independence Goals: The second part of the survey assessed the participants' targeted post-rehabilitation independence levels for the specified 10 ADLs. Participants selected one of four mutually exclusive categories that reflect standard rehabilitation outcomes:
- Complete Independence (can perform without help),
- Modified Independence (requires an assistive device),
- Assisted (requires personal assistance),
- Total Dependence (unable to perform the activity).
Statistical Analysis: The data were analyzed using the SPSS Statistics 22.0 program. The normality of continuous variables was assessed using the Shapiro-Wilk test. For variables showing a normal distribution, independent samples t-tests and one-way ANOVA were used for group comparisons. For data that did not show a normal distribution, the Mann-Whitney U and Kruskal-Wallis tests were applied. The chi-square test was used for the analysis of categorical data; the Fisher exact test was used when the test conditions could not be met. The statistical significance level was set at p<0.05.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Spinal Cord Injury | – | –This observational group consists of 56 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 . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Male and female patients aged 18-60
- Tetraplegic or paraplegic due to spinal cord injury
- At least 1 month has passed since the rehabilitation begining
- Patients who agree to participate in the study and provide written consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived Importance of Activities of Daily Living (ADLs) Assessed by Visual Analog Scale (VAS)
Time frame: Baseline
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 10-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) Questionnaire.
1 secondary outcome
Post-Rehabilitation İndependence Goals for ADLs
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 32879577Agarwal 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.
- Background: PubMed 39060481Ullah 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.
- Background: PubMed 18209742Ditunno 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Coşkun, MD Prof study chair
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries (SCI), run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Importance of Activities of Daily Living (ADLs) Assessed by Visual Analog Scale (VAS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.