跳至主要内容
临床试验/NCT07549217
NCT07549217尚未招募不适用

The Relationship Between Kinesiophobia and Fear of Falling, Functional Independence, and Psychological Status in Individuals With Paraplegic Spinal Cord Injury: A Cross-Sectional Study

Istanbul Physical Medicine Rehabilitation Training and Research Hospital0 个研究点目标入组 70 人开始时间: 2026年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
Tampa Scale for Kinesiophobia (TSK)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Tampa Scale for Kinesiophobia (TSK)

时间窗: 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.

次要结局

  • Spinal Cord Independence Measure-III Self-Report (SCIM-III SR)(Baseline)
  • Spinal Cord Injury-Falls Concern Scale (SCI-FCS)(Baseline)
  • Visual Analog Scale (VAS)(Baseline)
  • DN4 Neuropathic Pain Questionnaire(Baseline)
  • Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Baseline)
  • Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(Baseline)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

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