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临床试验/CTRI/2025/10/095762
CTRI/2025/10/095762尚未招募不适用

Development and Validation of Post-Stroke Functional Transition Scale for assessing Mobility Transitions in Stroke Rehabilitation.

GALGOTIAS UNIVERSITY1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Development and validation of Post stroke functional transition scale for assessing functional transitions during stroke rehabilitation

研究概览

简要总结

The study focuses on developing and validating the Post Stroke Functional Transition Scale (PFTS) to assess mobility transitions in stroke rehabilitation. Stroke is a leading cause of long term disability and there is currently no standardized tool to evaluate functional transitions such as moving from sitting to walking. The aim of the research is to create and validate PFTS to guide targeted rehabilitation strategies. The methodology involves a prospective cohort study including patients aged 30 to 65 years within three months post stroke. The scale will be developed using expert consensus through the Delphi method, followed by pilot testing and large scale validation. Reliability will be measured using inter rater and intra rater methods, and validity through comparison with existing mobility scales. Expected outcome is that PFTS will provide a reliable and evidence based tool to track progress and improve rehabilitation outcomes for stroke patients.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Clinically confirmed ischemic or primary intracerebral hemorrhagic stroke (non-traumatic).
  • Post-stroke duration between 2 weeks and 12 months from onset.
  • Able to maintain unsupported sitting balance for more than 30 seconds Cognitive status: Able to understand and follow one-step verbal commands.
  • 6Medically stable and cleared for participation in rehabilitation by a physician.
  • Willing and able to provide written informed consent.

排除标准

  • Severe cognitive or communication impairment Severe comorbidities affecting mobility Severe cardiopulmonary disease Other neurological disorders that may confound motor performance Unstable medical condition Severe sensory deficits affecting mobility Patients with subarachnoid hemorrhage, subdural or epidural hematoma, traumatic intracranial hemorrhage, or traumatic brain injury.

结局指标

主要结局

Development and validation of Post stroke functional transition scale for assessing functional transitions during stroke rehabilitation

时间窗: baseline and one month

次要结局

  • Responsiveness of Post stroke functional transition scale to rehabilitation changes.(Baseline and 2 months)

研究者

发起方
GALGOTIAS UNIVERSITY
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Sonika Girsa

Galgotias University

研究点 (1)

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