The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)
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: hyperbaric oxygen therapy.
- Кому может быть актуально
- Состояния в реестре: Anterior Cruciate Ligament Reconstruction. Базовые параметры: 18 лет — 45 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
- Израиль
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
Обзор
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.
Подробное описание
ACL rapture (Anterior cruciate ligament reconstruction rehabilitation) is a common injury in sports and cause severe functional problem. The big concern with this injury is the time to return to sport, this is the interest of the athlete.
The preferred treatment today when it comes to active athletes is to have an anterior cruciate ligament reconstruction (ACLR) ,the return to high function and sports after anterior cruciate ligament reconstruction (ACLR) surgery lasts about 8 months.
In the last few years, knowledge has been accumulating regarding the effectiveness of the new hyperbaric oxygen protocols in accelerating the healing of wounds and tissue damage. it was found that Hyperbaric oxygen therapy (HBOT) for ligament injuries in mice improves the quality and speed of recovery. The effect of HBOT on the rate of ligament healing has not yet been properly tested in humans.
The constant search for accelerated recovery in sports injuries along with the benefit of the HBOT in tissue healing processes encouraged the need to investigate the rate of recovery after a sports injury under HBOT. Two previous human studies in which medial collateral tear was tested showed positive effect on pain, physical outcome (decreased edema, range of motion and maximal knee flex) and accelerate the return to play. These findings with the fact that ACL injuries are common among athletes and can limit return to sports, reinforce the need to examine the effect of HBOT following ACLR in the terms of improving and speeding up recovery.
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.
Вмешательства
- Устройство hyperbaric oxygen therapy
The HBOT protocol consists of 6 weeks protocol including 5 daily HBOT sessions per week (total of 30), each session lasts 90 minutes, of 100% oxygen at 2 atmosphere absolute (ATA) with 5-minute air breaks every 20 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux Starmed 2700, Germany) located at the Sagol center for hyperbaric medicine and research, Shamir (Assaf-Harofeh) Medical Center, Israel.
Первичные конечные точки
- International Knee Documentation Committee [Срок оценки: Change from Baseline immediately after the intervention]
Вторичные конечные точки (12)
- Knee MRI [Срок оценки: Change from Baseline immediately after the intervention]
- Laxity ligament test [Срок оценки: Change from Baseline immediately after the intervention]
- physical measurement - ROM [Срок оценки: Change from Baseline immediately after the intervention]
- physical measurement - Edema [Срок оценки: Change from Baseline immediately after the intervention]
- physical measurement - Vas for pain [Срок оценки: Change from Baseline immediately after the intervention]
- physical measurement - Maximal quadriceps power by dynamometer [Срок оценки: Change from Baseline immediately after the intervention]
- Functional scores- (PROM) [Срок оценки: Change from Baseline immediately after the intervention]
- Functional scores - Vas for global rating of knee function [Срок оценки: Change from Baseline immediately after the intervention]
- Short form health survey (sf-36) [Срок оценки: Change from Baseline immediately after the intervention]
- Functional measurement [Срок оценки: Change from Baseline immediately after the intervention]
- Functional measurement - (SEBT) [Срок оценки: Change from Baseline immediately after the intervention]
- Functional measurement - Single Hop test [Срок оценки: Change from Baseline immediately after the intervention]
Критерии участия
Критерии включения
- Subjects willing and able to read, understand and sign an informed consent
- Age 18-45
- Anterior cruciate ligament tear for reconstruction (with or without meniscal repair).
Критерии исключения
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Additional injury
- An inability to perform MRI.
- Active malignancy
- Chest pathology incompatible with pressure changes (including active asthma)
- Ear or sinus pathology incompatible with pressure changes
- History of epilepsy
- Claustrophobia
- Previous knee surgery
- Participation in another study
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Израиль · 1 центр
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Идентификаторы
NCT: NCT06493851 · 0166-23