Spinal Cord InjuriesNCT07549217
Kinesiophobia, Fear of Falling, Functional Independence, and Psychological Status in Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
Trial summary
Individuals aged 18-65 years who have been clinically diagnosed with spinal cord injury and have developed paraplegia will be included in the study. Demographic and clinical data of the participants, including age, sex, height, weight, etiology of injury, level of injury, duration of injury, and comorbidities, will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 20 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Adult, Older adult
Study population: Spinal cord injury patients
Who may be able to join
- Aged between 18 and 65 years
- Clinically diagnosed with spinal cord injury
- Presence of paraplegia
- Injury duration of at least 3 months (to exclude acute phase effects)
- Medically stable condition
- Ability to understand and respond to questionnaires
- Willingness to participate and provide written informed consent
Who cannot join
- Tetraplegia or other neurological conditions affecting motor function
- Severe cognitive impairment or psychiatric disorders that may interfere with assessments
- Presence of active infection, malignancy, or severe systemic disease
- Severe visual or hearing impairment preventing participation in assessments
- Current participation in another interventional clinical study
- Recent surgery or acute medical condition within the last 3 months
- Incomplete clinical data or inability to complete questionnaires
About this study
Official title: The Relationship Between Kinesiophobia and Fear of Falling, Functional Independence, and Psychological Status in Individuals With Paraplegic Spinal Cord Injury: A Cross-Sectional Study
Individuals aged 18-65 years who have been clinically diagnosed with spinal cord injury and have developed paraplegia will be included in the study. Demographic and clinical data of the participants, including age, sex, height, weight, etiology of injury, level of injury, duration of injury, and comorbidities, will be recorded. In addition, disease-specific characteristics such as ambulation status, wheelchair use, presence of incontinence, and presence and severity of pain will be assessed.
Kinesiophobia levels of the patients will be evaluated using the Tampa Scale for Kinesiophobia (TSK). Functional independence will be assessed using the Spinal Cord Independence Measure-III Self-Report (SCIM-III SR). Fall-related concerns will be evaluated using the Spinal Cord Injury-Falls Concern Scale (SCI-FCS). Pain severity will be assessed using the Visual Analog Scale (VAS), and the presence of neuropathic pain will be evaluated using the DN4 Neuropathic Pain Questionnaire.
Symptoms related to anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). All assessments will be conducted through face-to-face interviews. The collected data will be analyzed to investigate the relationship between kinesiophobia and functional independence, fear of falling, pain, and psychological status in individuals with paraplegic spinal cord injury. Validated Turkish versions of all scales used in the study will be employed.
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale for Kinesiophobia (TSK)
The TSK is a self-reported questionnaire used to assess fear of movement/re-injury. It consists of 17 items scored on a 4-point Likert scale, with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia.
Measured: Baseline
Secondary outcomes (6)
Spinal Cord Independence Measure-III Self-Report (SCIM-III SR)
The SCIM-III SR evaluates functional independence in individuals with spinal cord injury. It includes domains such as self-care, respiration and sphincter management, and mobility. Total scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Baseline
Spinal Cord Injury-Falls Concern Scale (SCI-FCS)
The SCI-FCS assesses concerns about falling during daily activities in individuals with spinal cord injury. Higher scores indicate greater fear of falling.
Measured: Baseline
Visual Analog Scale (VAS)
Pain intensity is measured using a 10-cm visual analog scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline
DN4 Neuropathic Pain Questionnaire
The DN4 questionnaire is used to identify neuropathic pain. A score of ≥4 suggests the presence of neuropathic pain.
Measured: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
The HADS-A subscale consists of 7 items assessing anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety levels.
Measured: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
The HADS-D subscale consists of 7 items assessing depressive symptoms. Scores range from 0 to 21, with higher scores indicating greater depression levels.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 May 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549217
- Sponsor's protocol ID
- Istftreah11
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Kinesiophobia and Fear of Falling, Functional Independence, and Psychological Status in Individuals With Paraplegic Spinal Cord Injury: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07549217
- Acronym / sponsor ID
- Istftreah11
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 24 Apr 2026 (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.
Individuals aged 18-65 years who have been clinically diagnosed with spinal cord injury and have developed paraplegia will be included in the study. Demographic and clinical data of the participants, including age, sex, height, weight, etiology of injury, level of injury, duration of injury, and comorbidities, will be recorded. In addition, disease-specific characteristics such as ambulation status, wheelchair use, presence of incontinence, and presence and severity of pain will be assessed.
Kinesiophobia levels of the patients will be evaluated using the Tampa Scale for Kinesiophobia (TSK). Functional independence will be assessed using the Spinal Cord Independence Measure-III Self-Report (SCIM-III SR). Fall-related concerns will be evaluated using the Spinal Cord Injury-Falls Concern Scale (SCI-FCS). Pain severity will be assessed using the Visual Analog Scale (VAS), and the presence of neuropathic pain will be evaluated using the DN4 Neuropathic Pain Questionnaire.
Symptoms related to anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). All assessments will be conducted through face-to-face interviews. The collected data will be analyzed to investigate the relationship between kinesiophobia and functional independence, fear of falling, pain, and psychological status in individuals with paraplegic spinal cord injury. Validated Turkish versions of all scales used in the study will be employed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Spinal cord injury patients
Key inclusion criteria (7 listed)
- Aged between 18 and 65 years
- Clinically diagnosed with spinal cord injury
- Presence of paraplegia
- Injury duration of at least 3 months (to exclude acute phase effects)
- Medically stable condition
Key exclusion criteria (7 listed)
- Tetraplegia or other neurological conditions affecting motor function
- Severe cognitive impairment or psychiatric disorders that may interfere with assessments
- Presence of active infection, malignancy, or severe systemic disease
- Severe visual or hearing impairment preventing participation in assessments
- Current participation in another interventional clinical study
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
Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline
The TSK is a self-reported questionnaire used to assess fear of movement/re-injury. It consists of 17 items scored on a 4-point Likert scale, with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia.
6 secondary outcomes
Spinal Cord Independence Measure-III Self-Report (SCIM-III SR)
Time frame: Baseline
Spinal Cord Injury-Falls Concern Scale (SCI-FCS)
Time frame: Baseline
Visual Analog Scale (VAS)
Time frame: Baseline
DN4 Neuropathic Pain Questionnaire
Time frame: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Tampa Scale for Kinesiophobia (TSK) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.