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【ChiCTR2100046313】Virtual Reality assisted Lower Limbs MuscleTraining for Knee Osteoarthritis

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基本信息

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ChiCTR2100046313

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-05-13

临床申请受理号

靶点

适应症

Knee osteoarthritis

试验通俗题目

Virtual Reality assisted Lower Limbs MuscleTraining for Knee Osteoarthritis

试验专业题目

Virtual Reality assisted Lower Limbs Muscle Training for Patients with Knee Osteoarthritis: A pilot randomized controlled trial

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临床试验信息

试验目的

The aim of this study is to pilot test the feasibility and test the measurement instrument of a virtual reality-assisted lower limbs muscle strengthening exercise for patients with knee osteoarthritis.

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

An off-site statistician will perform 1:1 randomization to allocate the participants into 2 groups.

盲法

In this open-label study, binding of patients will not be possible. However, research assistants and statisticians involved in data collection and analysis, respectively, were blinded to the allocation status.

试验项目经费来源

Hong Kong Jockey Club Charities Trust

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-05-14

试验终止时间

2022-05-13

是否属于一致性

入选标准

Participants should have a diagnosis of knee OA based on clinical and radiographic criteria (Kellgren-Lawrence grade ≥ 2) as defined by the American Rheumatology College; moderate-to-severe knee pain for at least 3 months, defined as a score of >=4 (on a 0–10 numerical rating scale) in response to the question What is the average level of your left/right knee pain in the past 3 months?".；

排除标准

Participants with decompensated organic and psychiatric disease; with contraindications to virtual reality therapy, such as epilepsy or severe myopia (> -3.5 dioptres); and with comorbidity or lifestyle factors precluding participation in the study.；

研究者信息

研究负责人姓名

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试验机构

The Chinese University of Hong Kong

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