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Идёт набор NCT06762392

Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.

Без фазы С лечением Anterior Cruciate Ligament Reconstruction Rehabilitation

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: Blood Flow Restriction, Standard Rehabilitation.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Reconstruction Rehabilitation. Базовые параметры: от 18 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
Испания
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 goal of this clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery. The main questions it aims to answer are: Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone? Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery? Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.

Подробное описание

Anterior Cruciate Ligament (ACL) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. Despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role.

This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely.

The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.

Вмешательства

  • Другое Blood Flow Restriction
    Blood Flow Restriction (BFR) therapy in this study involves the application of a pneumatic cuff around the proximal thigh to restrict arterial blood flow during specific rehabilitation exercises. The cuff will be inflated to achieve 70-80% of arterial occlusion, while participants perform low-intensity resistance exercises at 15-20% of their one-repetition maximum (1RM). BFR therapy will be used during Phase 2 of rehabilitation (weeks 2-12) alongside a standardized rehabilitation protocol. The i
  • Другое Standard Rehabilitation
    The Standard Rehabilitation (RHB) intervention in this study consists of a structured, evidence-based protocol designed to optimize recovery after anterior cruciate ligament (ACL) reconstruction. This rehabilitation protocol is implemented across four phases. The rehabilitation will be supervised by experienced Physical Therapists, and participants will be given a tailored home exercise program to complement the supervised sessions. The intervention aims to optimize recovery, restore function, a

Первичные конечные точки

  • Pain Intensity [Срок оценки: From baseline to the end of the intervention at 24 weeks]
  • Strength [Срок оценки: From baseline to the end of the intervention at 24 weeks]
  • Range of Motion [Срок оценки: From baseline to the end of the intervention at 24 weeks]
Вторичные конечные точки (3)
  • Kinesiophobia [Срок оценки: From baseline to the end of the intervention at 24 weeks]
  • Patient's Quality of Life [Срок оценки: From baseline to the end of the intervention at 24 weeks]
  • Functional Performance [Срок оценки: From baseline to the end of the intervention at 24 weeks]

Критерии участия

Критерии включения

  • Patients aged between 18 and 45 years.
  • Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery

Критерии исключения

  • Cardiovascular comorbidities
  • Severe metabolic disorders or postoperative complications
  • Previous joint disorders requiring surgery on the affected leg
  • Pregnancy
  • Coagulation disorders

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Faculty of Physiotherapy — Valencia

Идентификаторы

NCT: NCT06762392 · UV-INV_ETICA-3498956

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗