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Набор скоро начнётся NCT07423819

Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia

Без фазы С лечением Anterior Cruciate Ligament Injury Patellofemoral Pain Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Muscle Strength Training, Lower limb balance and stability exercises, Stretching and Relaxation.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary objective of this clinical trial is to verify the superiority of a digital diagnosis and treatment system for the conservative management of knee sports injuries-based on wearable sensors, machine vision, and large language models-over conventional off-site rehabilitation in terms of functional outcomes. The secondary objectives include assessing safety and adverse events, compliance and feasibility, algorithm evaluation accuracy and usability, and generating clinical evidence to support the registration of a Class II medical device. Participants will undergo a six-month intervention comprising knee muscle strengthening exercises, lower limb balance and stability training, and stretching exercises. Follow-up assessments will be conducted every four weeks, recording IKDC and Lysholm subjective knee function scores, VAS pain scores, SF-36 quality of life scores, knee range of motion, and MRI findings.

Вмешательства

  • Другое Muscle Strength Training
    Wall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises.
  • Другое Lower limb balance and stability exercises
    Single-leg balance stance, step-up/step-down, lower limb Y-balance single-leg stance training, lower limb single-leg stance star excursion balance training, quadruped position support, and similar exercises.
  • Другое Stretching and Relaxation
    After each training session, you can perform muscle stretching or use methods such as resistance band exercises or foam roller rolling for muscle relaxation.

Первичные конечные точки

  • International Knee Documentation Committee Subjective Knee Form Score [Срок оценки: week0、week4、week8、week12、week24]
  • Lysholm Knee Scoring Scale [Срок оценки: week0、week4、week8、week12、week24]
Вторичные конечные точки (4)
  • Visual Analogue Scale [Срок оценки: week0、week4、week8、week12、week24]
  • 36-Item Short Form Health Survey [Срок оценки: week0、week4、week8、week12、week24]
  • Knee Range of Motion [Срок оценки: week0、week4、week8、week12、week24]
  • Knee MRI [Срок оценки: week0、week4、week12、week24]

Критерии участия

Критерии включения

  • Age 18-50 years.
  • Clinical symptoms, signs, and MRI diagnosis confirming ACL rupture.
  • First-time unilateral ACL rupture.
  • Clinical symptoms, signs, and MRI diagnosis confirm patellofemoral cartilage injury.
  • Presence of at least one of the following manifestations:
  • Initially, unilateral knee presents with dull pain, soreness, or a sense of weakness, followed by increased knee pain predominantly located behind the patella. Pain worsens after exertion, with difficulty climbing up or down stairs, and alleviates or disappears after rest. The pain VAS score is ≤6 points.
  • Positive unilateral knee patellar grind test and/or positive patellar compression test and/or positive squat test.
  • Ability to understand and sign the informed consent form, voluntarily participate in the study, and cooperate with follow-up.

Критерии исключения

  • Body Mass Index (BMI) less than 18.5 or greater than 35 kg/m²;
  • Age greater than 50 years or less than 18 years;
  • History of knee surgery or presence of other conditions, such as tumors, rheumatoid arthritis, tuberculosis, etc.;
  • Severe cardiopulmonary dysfunction, neurological disorders, or other conditions unsuitable for exercise rehabilitation;
  • Pregnant or lactating women;
  • Individuals unwilling to undergo this treatment method.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 4 центра
  • Beijing Jishuitan Hospital — Пекин
  • Peking Union Medical College Hospital — Пекин
  • Peking University People's Hospital — Пекин
  • Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07423819 · M20260058

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗