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临床试验/NCT07449078
NCT07449078招募中不适用

Investigating the Effects of Cognitive Functional Therapy on Pain, Physical Function, and Kinesiophobia in Individuals With Chronic Ankle Sprain

Yeditepe University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
FAAM

研究概览

简要总结

The aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS).

详细描述

The aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS). This study will follow a structured clinical research protocol designed to evaluate the effects of Cognitive Functional Therapy (CFT) on individuals with chronic ankle sprain.

This study is an experimental clinical intervention with a two-time-point measurement design. The Cognitive Functional Therapy (CFT) program will be applied to individuals with chronic ankle sprain, and its effects will be evaluated at baseline (before intervention) and after the 12-week intervention.

The study will take place between January 2026 and June 2026. All participants will undergo an initial eligibility screening by an orthopedic specialist prior to enrollment. Following informed consent, eligible participants will attend a baseline assessment session, complete validated self-report questionnaires, and then begin a 12-week individualized CFT program consisting of seven sessions. Interventions will be delivered by a trained physiotherapist with clinical experience in musculoskeletal rehabilitation and certification in CFT principles. All data collection, including digital files and paper records, will be securely stored in encrypted systems accessible only to the research team. At the conclusion of the 12-week program, participants will fill the same questionnaires they filled at the beginning of the study as an outcome measurement.

The outcome measurements are VAS, TSK-17, and FAAM questionnaires.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Ongoing pain or swelling, "giving way" episodes, and re-injury during sports or daily activity
  • Adults aged 18-65 years
  • History of lateral ankle sprain with symptoms persisting for more than 3 months
  • Continuing symptoms such as pain, instability, or activity limitations
  • Ability to understand and communicate in English or Arabic

排除标准

  • History of ankle surgery within the past 12 months
  • Advanced ankle osteoarthritis or systemic inflammatory, neurological, or vestibular conditions
  • Currently undergoing physiotherapy for the same condition
  • Cognitive impairment or severe psychological disorder that could interfere with participation
  • Pregnancy or planned pregnancy during the study period
  • Any other condition deemed unsuitable by the research team

研究组 & 干预措施

Cognitive Functional Therapy Group

Experimental

Cognitive Functional Therapy

干预措施: Cognitive Functional Therapy (Procedure)

结局指标

主要结局

FAAM

时间窗: 12 Weeks

Foot and Ankle Ability Measure

TSK-17

时间窗: 12 Weeks

Tampa Scale of Kinesiophobia

VAS

时间窗: 12 Weeks

Visual Analogue Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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