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临床试验/NCT06894706
NCT06894706已完成不适用

Lanzhou Anning District People's Hospital

Biao Yang1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Demographic data comparison

研究概览

简要总结

AIM: To investigate the impact of functional exercise training on postoperative functional recovery in patients with knee meniscus injuries.

METHODS:A prospective randomized controlled trial (RCT) was conducted from April 2023 to September 2024, involving 96 patients with knee meniscus injuries who underwent meniscus repair interventions. Participants were randomly assigned to either the Control (CON) group (n=48) or the functional exercise training (FET) group (n=48) using a computer-generated random number table. The CON group received standard rehabilitation, while the FET group underwent functional exercise training. Clinical outcomes were evaluated at baseline, 1 month, and 6 months post-intervention, including the Lysholm score, IKDC score, VAS pain score, range of motion (ROM), serum levels of prostaglandin E2 (PGE2) and serotonin (5-HT), as well as passive 60° position sense and 60° motion sense. Postoperative complications occurring within 1 month were also recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.

排除标准

  • •Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.

研究组 & 干预措施

Control (CON) group

Other

Both groups were given arthroscopy and meniscoplasty. After operation, the control group received active knee flexion and extension exercise, ankle pump training, quadriceps muscle training and other routine rehabilitation training.

干预措施: Control (CON) group (Behavioral)

Functional exercise training (FET) group

Other

Patients in the observation group were supplemented with neuromuscular training on the basis of routine rehabilitation training, and received rehabilitation education before training. The patients were informed of the specific content, frequency, expected effect and importance of training in various forms such as on-site demonstration combined with publicity brochures and playing videos, so as to improve patient cooperation.

干预措施: Functional exercise training (FET) group (Behavioral)

结局指标

主要结局

Demographic data comparison

时间窗: baseline, pre-intervention

次要结局

  • Range of Motion(up to 24 weeks)
  • Lysholm Knee Scoring Scale scores(up to 24 weeks)
  • International Society of Knee Injuries and Arthroscopy Score(up to 24 weeks)
  • Visual Analog Scale(up to 24 weeks)
  • Passive position sense(up to 24 weeks)
  • Kinesthesia test(up to 24 weeks)
  • Prostaglandin E2(up to 24 weeks)
  • 5-hydroxytryptamine(up to 24 weeks)
  • complications(up to 24 weeks)

研究者

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

Biao Yang

Lanzhou Anning District People's Hospital

Lanzhou Anning District People's Hospital

研究点 (1)

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