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Not yet recruiting NCT07549217

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

— Observational Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Primary outcome measures

  • Tampa Scale for Kinesiophobia (TSK) [Time frame: Baseline]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07549217 · Istftreah11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗