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临床试验/NCT07504848
NCT07504848尚未招募不适用

The Effect of Mobility Level in Stroke Patients on Anxiety, Depression, and Caregiver Burden in Caregivers

Ondokuz Mayıs University0 个研究点目标入组 64 人开始时间: 2026年4月2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
64
主要终点
Timed Up and Go Test

研究概览

简要总结

This study was designed to determine the effect of functional mobility levels of stroke patients on caregiver burden, anxiety, and depression in their caregivers.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke Patients:
  • Diagnosed with stroke according to WHO criteria (≥20% disability rate documented in Adult Disability Health Board Report)
  • Having a family member or relative who provides care
  • First-ever and unilateral stroke
  • Willing to participate voluntarily
  • Aged between 18-75 years
  • Post-stroke duration longer than 3 months
  • Stable vital signs
  • Scoring ≥24 on the Standardized Mini-Mental State Examination (SMMT) or the -Modified Mini-Mental State Examination for Illiterate Individuals (MMSE-E)
  • Able to understand and speak Turkish
  • Caregivers of Stroke Patients:
  • Willing to participate in the study
  • Living with the patient for at least 1 year
  • Being the primary (main responsible) caregiver and not receiving paid professional caregiving services
  • Aged 18 years or older
  • Scoring ≥24 on the Standardized Mini-Mental State Examination (SMMT) or MMSE-E

排除标准

  • Stroke Patients:
  • Presence of severe comorbid conditions
  • Unwillingness to participate
  • History of multiple strokes
  • Bilateral hemiplegia
  • Presence of major neurological, orthopedic, or rheumatologic disorders affecting the musculoskeletal system other than stroke
  • Congenital anomalies or amputation causing disability
  • Uncontrolled arrhythmia, uncontrolled hypertension, or unstable cardiac conditions
  • Botulinum toxin injection within the last 6 months
  • Inability to establish cooperation
  • Presence of neglect, aphasia, or hemianopsia
  • Caregivers of Stroke Patients:
  • Unwillingness to participate
  • Living with the patient for less than 1 year
  • Presence of mental retardation, dementia, or severe psychotic disorders

研究组 & 干预措施

Stroke Patients

Caregivers

结局指标

主要结局

Timed Up and Go Test

时间窗: Baseline

Brunnstrom Stages of Hemiplegic Recovery

时间窗: Baseline

Beck Depression Inventory

时间窗: Baseline

The Beck Depression Inventory (BDI) is scored between 0 and 63, where 0 indicates minimal or no depressive symptoms and 63 reflects severe depression; increasing scores correspond to greater severity of depressive symptomatology.

Burden Interview

时间窗: Baseline

Rivermead Mobility Index

时间窗: Baseline

The Rivermead Mobility Index (RMI) ranges from 0 to 15. 0 indicates severe dependence with inability to perform basic mobility tasks. 15 indicates full independence in all assessed mobility activities. As the score increases, it reflects a progressive improvement in functional mobility, with greater independence in activities such as transfers, walking, and balance.

Beck Anxiety Inventory

时间窗: Baseline

Beck Anxiety Inventory (BAI) ranges from 0 to 63, with 0 indicating minimal anxiety and 63 indicating severe anxiety; higher scores represent increased severity of anxiety symptoms.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Nur Kemer

Lecturer, PhD

Ondokuz Mayıs University

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