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临床试验/NCT06251414
NCT06251414已完成不适用

Study on the Effect of Blood Flow Restriction Training Combined With IASTAM on Symptoms in Patients With Chronic Ankle Instability

Yang Liu1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Foot and Ankle Ability Measure(FAAM)

研究概览

简要总结

Purpose; Through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (Instrument Soft Tissue Release Technique, IASTM), the intervention effect on ankle function, strength, and joint range of motion of sports dance athletes with ankle instability was observed.

Method; 45 subjects with unstable, restricted or uncomfortable ankle joints were selected as observation subjects and randomly divided into ankle blood flow restriction training combined with IASTM group (n=15), ankle blood flow restriction training alone (n=15), and traditional ankle strength training (n=15). The intervention lasted for 6 weeks, once a week. Cumberland ankle instability assessment, FAAM ankle function assessment score, and ankle range of motion measurement were performed at three time points before intervention, after the first intervention, and after 6 weeks of intervention for three groups. The ankle strength test was only compared and analyzed at two time points before and after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-35 years old
  • Course of illness: Suffering from chronic ankle instability symptoms that last for at least 3 months
  • Symptoms: Ankle instability, frequent ankle sprains, discomfort during walking or exercise
  • Functional screening: Two or more tests tested positive for ankle joint function screening before the experiment
  • Structural examination: No joint structural lesions or congenital ankle deformities,
  • Medical history: Have not undergone ankle surgery or have external injuries
  • Health status: No serious heart, lung, nervous system or other systemic diseases
  • Exercise level: Able to complete the exercise intervention and evaluation tasks specified in the experiment
  • Agree to participate in the study: Has limited exercise ability and is unable to complete the research task

排除标准

  • Under 18 years old or over 35 years old
  • Acute ankle injury or no joint injury
  • No ankle instability or unwillingness to cooperate with research requirements
  • Failed ankle function screening
  • Structural lesions or congenital ankle deformities present in the ankle joint
  • Have undergone ankle surgery or have obvious injuries or wounds
  • Serious heart, lung, nervous system or other systemic diseases
  • Due to limited athletic ability, unable to complete research tasks
  • Disagree to participate in the study, or inability to understand and comply with the research protocol

结局指标

主要结局

Foot and Ankle Ability Measure(FAAM)

时间窗: 4-6week

Foot and Ankle Ability Measure (FAAM) is a scale used to evaluate ankle joint function, which includes questions about pain, function, and quality of life, and can be used to assess the overall condition of patients with ankle instability. The functional score includes two types of assessments: the functional level of daily life (FAAM-ADL) and the functional level of physical activity (FAAM-SPORT). The score range is usually from 0 to 100, where 100 represents completely normal ankle joint function, and 0 represents extreme restriction or complete inability to use the ankle joint.

Cumberland Ankle Instability Tool,CAIT

时间窗: 4-6week

Evaluated the patient's perception of ankle instability, including the frequency, CAIT typically includes a specific range of questions, each of which may have different scores. The total score is usually between 0 and 30 points, with higher scores indicating higher stability intensity, and impact of symptoms

Ankle joint strength test

时间窗: 4-6week

The experimental strength data was tested using a handheld digital muscle strength tester (model: FM-204M series muscle strength tester). The measurement unit of this muscle strength tester is N, with a measurement unit range of ± 50kgf and a measurement accuracy of ± 0.5% FS (range) ± 1 digital peak. The measured data includes both peak strength and instantaneous strength values. Therefore, this study used a handheld digital muscle strength tester, where participants sat in a suitable position, fixed the bottom of the instrument on the ground, and then applied force in different directions through their ankles. Measure the maximum force in the direction of dorsiflexion and plantarflexion of the ankle joint, abduction and eversion of the foot, and adduction and eversion. The strength test for each different exercise segment needs to be completed three times, and the average of the maximum strength values from the three tests is taken.

Ankle joint range of motion

时间窗: 4-6week

This study used a high-precision joint motion angle measuring ruler to measure the range of motion of different ankle functions in both sitting and supine positions, including measurements of dorsiflexion and plantar flexion of the ankle, as well as measurements of varus and eversion of the foot. The larger the angle, the better the improvement in joint motion.

次要结局

未报告次要终点

研究者

发起方
Yang Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yang Liu

doctor

Wuhan Sports University

研究点 (1)

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