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NCT Number: NCT07549217

Kinesiophobia, Fear of Falling, Functional Independence, and Psychological Status in Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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