- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549217
Kinesiophobia, Fear of Falling, Functional Independence, and Psychological Status in Spinal Cord Injury
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal Cord Independence Measure-III Self-Report (SCIM-III SR)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Spinal Cord Injury-Falls Concern Scale (SCI-FCS)
Time Frame: Baseline
|
The SCI-FCS assesses concerns about falling during daily activities in individuals with spinal cord injury.
Higher scores indicate greater fear of falling.
|
Baseline
|
|
Visual Analog Scale (VAS)
Time Frame: Baseline
|
Pain intensity is measured using a 10-cm visual analog scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Baseline
|
|
DN4 Neuropathic Pain Questionnaire
Time Frame: Baseline
|
The DN4 questionnaire is used to identify neuropathic pain.
A score of ≥4 suggests the presence of neuropathic pain.
|
Baseline
|
|
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time Frame: Baseline
|
The HADS-A subscale consists of 7 items assessing anxiety symptoms.
Scores range from 0 to 21, with higher scores indicating greater anxiety levels.
|
Baseline
|
|
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time Frame: Baseline
|
The HADS-D subscale consists of 7 items assessing depressive symptoms.
Scores range from 0 to 21, with higher scores indicating greater depression levels.
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istftreah11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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