跳至主要内容
临床试验/NCT07544693
NCT07544693尚未招募不适用

Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis: a Randomized Single-blind Trial of Muscle Training and Knee Orthosis Intervention

Kaohsiung Veterans General Hospital.0 个研究点目标入组 120 人开始时间: 2026年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
maximal voluntary isometric contraction (MVC)

研究概览

简要总结

This study aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis

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
Single (Participant)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 55 to 75 years.
  • 2. Diagnosed with moderate knee traumatic arthritis (Kellgren-Lawrence classification II or III)(experimental group).
  • The control group must not have a diagnosis of osteoarthritis of the knee and must have normal knee joint function.
  • 3. Physical Health Status: Able to perform basic movements requiring isometric knee contraction tests and electromyography recording.
  • 4. Able to wear knee orthotics.

排除标准

  • 1. Knee or lower extremity injury: Recent (within the past 6 months) history of severe injury, fracture, or surgery to the knee or lower extremity.
  • 2. Other joint disorders: Coexisting joint disorders (such as rheumatoid arthritis or gouty arthritis).
  • 3. Neuromuscular disorders: Presence of neuromuscular dysfunction, such as stroke, Parkinson's disease, or peripheral neuropathy.
  • 4. Uncontrolled cardiovascular disease, hypertension, diabetes, or other medical conditions.
  • Taking medications that affect neuromuscular function.
  • 5. Allergy or intolerance: Allergy to laboratory equipment (such as electromyography electrode gel) or knee brace materials.

研究组 & 干预措施

controls group

Sham Comparator

干预措施: the strengthening program (Behavioral)

Group A with the corrective knee orthosis

Experimental

patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will receive a valgus-corrective knee orthosis.

干预措施: the strengthening program (Behavioral)

Group B without the corrective knee orthosis

Placebo Comparator

patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will not receive a valgus-corrective knee orthosis.

干预措施: the strengthening program (Behavioral)

结局指标

主要结局

maximal voluntary isometric contraction (MVC)

时间窗: Baseline and 3 weeks

The Western Ontario and McMaster Universities Turkish (WOMAC) index

时间窗: baseline, 3 weeks

a self-administered questionnaire that assesses three aspects of a patient's health status -pain, stiffness, and physical function - in those with lower limb Osteoarthritis. WOMAC consists of 24 questions, with a total score ranging from 0 to 96 points. there are three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). a five-tier classification of symptomatic severity: minimal or no symptoms (≤24 score), mild (25-41 score), moderate (42-69 score), severe (70-86 score), and extreme (≥87 score).

The Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: Baseline and 3 weeks

a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. Knee Injury and Osteoarthritis Outcome Score (KOOS) has five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions). The total score of each question (0-4 points) is converted into a score of 0-100, where 100 points represents the best knee health and 0 points represents the worst.

Motor Unit Recruitment (amplitude relative to recruitment threshold)

时间窗: Baseline and 3 weeks

surface EMG decomposition

Motor Unit Recruitment (firing rate relative to recruitment threshold)

时间窗: Baseline and 3 weeks

surface EMG decomposition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CHEN YUEH

Doctor of Medicine

Kaohsiung Veterans General Hospital.

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