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临床试验/ITMCTR2026001734
ITMCTR2026001734进行中(未招募)Unknown

A Study on Changes in Knee Biomechanics in Patients with Knee Osteoarthritis Practising That Include Three Steps and Six Movements on Gait Biomechanical Parameters

chen bingyan0 个研究点开始时间: 2026年7月15日最近更新:
适应症

试验速览

阶段
Unknown
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
50 至 70(—)
性别
All

入选标准

  • Diagnostic criteria for KOA: Diagnostic criteria for KOA established in accordance with the 2024 'Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis': 1) Recurrent knee pain within the past month; 2) Age = 50 years; 3) Morning stiffness lasting = 30 minutes; 4) Crepitus (or sensation of bone rubbing) during movement; 5) X-rays (taken in the standing or weight-bearing position) showing narrowing of the joint space, subchondral sclerosis or cystic changes, and the formation of osteophytes at the joint margins. A diagnosis of KOA can be made if criterion 1) is met along with any two of the other criteria.
  • Diagnostic criteria for early and middle stages: Refer to the diagnostic criteria for early and middle stages of KOA established in the 2024 edition of the 'Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis' and the 'Expert Consensus on the Integrated Traditional Chinese and Western Medicine Treatment of Knee Osteoarthritis (Xibì)'.
  • Inclusion criteria for KOA patients: 1) Aged 50–70 years, regardless of gender; 2) Consent to undergo gait analysis, blood sampling and other examinations, and ability to perform the exercise movements independently (without the need for assistive devices); 3) BMI < 28 kg/m²; 4) Voluntary participation and signing of an informed consent form; 5) Meeting the diagnostic criteria for early- to mid-stage KOA as outlined above.
  • Inclusion criteria for healthy subjects: 1) Aged 50–70 years, regardless of gender; 2) Consent to undergo examinations such as gait analysis and blood sampling; 3) BMI < 28 kg/m²; 4) Voluntary participation and signing of an informed consent form.

排除标准

  • for patients with early- to mid-stage KOA: 1) Patients in the acute phase of KOA (for the acute phase, refer to the *Guidelines for the Diagnosis and Treatment of Knee Osteoarthritis in Traditional Chinese Medicine (2020 Edition)*: knee pain (VAS score > 7), or persistent pain so severe that it prevents sleep; knee swelling, functional impairment, limping or even inability to walk); 2) Patients with severe cardiovascular or cerebrovascular disease, impaired liver or kidney function, haematological disorders, cognitive impairment, or mental illness; 3) Those with concomitant conditions such as rheumatoid arthritis, gout or osteoporosis; 4) Those with a history of intra-articular injections or surgical procedures within the past month; 5) Those with other conditions affecting normal lower limb movement or gait; 6) Those requiring analgesic medication for chronic or recurrent pain other than KOA; 7) Pregnant or breastfeeding women.
  • Exclusion criteria for healthy subjects: 1) Severe cardiovascular, cerebrovascular, hepatic or renal dysfunction, haematological disorders, cognitive impairment or psychiatric disorders; 2) Other conditions such as rheumatoid arthritis, gout or osteoporosis; 3) History of intra-articular injections or surgical procedures within the past month; 4) Systemic musculoskeletal diseases or functional impairments that may cause abnormal gait; 5) Pregnancy or lactation.

研究者

发起方
chen bingyan

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