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Идёт набор NCT07131787

Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery

Без фазы С лечением Achilles Tendon Rupture Blood Flow Restriction Therapy

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 training (smart-cuff pro device), Standardised strength training.
Кому может быть актуально
Состояния в реестре: Achilles Tendon Rupture, Blood Flow Restriction Therapy. 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
Бельгия
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 investigate whether rehabilitation with blood flow restriction (BFR) offers added value compared to conventional rehabilitation in patients undergoing surgical repair for Achilles tendon rupture. The study will include adult patients of all sexes who have undergone surgical treatment at two selected hospitals. The main questions it aims to answer are: Does BFR-enhanced rehabilitation improve functional recovery compared to conventional rehabilitation? What are the effects of BFR on muscle strength and tendon recovery? Researchers will compare blood flow restriction (BFR) therapy with conventional rehabilitation to determine whether BFR leads to improved clinical, muscular, and tendon-related outcomes. Participants will: 1. Undergo standard surgical repair of the Achilles tendon 2. Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery 3. Take part in follow-up assessments at weeks 4, 8, 12, 18, 24, and 52, which will include: * Questionnaires on pain, quality of life, fear of movement, and return to sport * Medical imaging techniques such as ultrasound, MRI, shear wave elastography, and power Doppler * Muscle strength testing * Blood sample collection, along with a tendon tissue sample taken during surgery

Вмешательства

  • Устройство Blood flow restriction training (smart-cuff pro device)
    This group will undergo low load strength training consisting of calf, thigh, glute and core exercises. A Blood flow restriction cuff will be added during selected exercises in rehabilitation program (targeting quadriceps and calf muscles)
  • Другое Standardised strength training
    This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.

Первичные конечные точки

  • Achilles tendon rupture score (ATRS) [Срок оценки: From enrollment week 0 (pre-injury score), week 12, week 18 and week 24 (the end of treatment at 6 months post-operative). Follow-up screening at week 52]
Вторичные конечные точки (12)
  • US: tendon cross-sectional area [Срок оценки: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52]
  • US: tendon length [Срок оценки: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52]
  • SWE: tendon stiffness [Срок оценки: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52]
  • Power doppler [Срок оценки: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52]
  • Heel rise endurance test [Срок оценки: week 18, week 24 Follow-up at week 52]
  • Possibility to perform one heel rise [Срок оценки: week 12]
  • Plantarflexion strength [Срок оценки: week 18, week 24, Follow-up at week 52]
  • Tampa scale of kinesophobia (TSK) [Срок оценки: week 4, week 24]
  • EQ-5D-5L [Срок оценки: week 0, week 4, week 12, week 24 Follow-up at week 52]
  • Tegner Activity Scale (TAS) [Срок оценки: From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52]
  • MRI: muscle volume [Срок оценки: week 4 and week 24 (pre- and post physical therapy)]
  • MRI: fatty infiltration [Срок оценки: week 4 and week 24 (pre- and post physical therapy)]

Критерии участия

Критерии включения

  • patients with total midrupture Achilles tendon rupture
  • surgical treatment
  • > 18 years old
  • able to understand and speak Dutch

Критерии исключения

  • Bilateral Achilles tendon rupture
  • Previous Achilles tendon rupture
  • Previous treatment with fluoroquinolones or cortisone
  • other condition in either leg that would limit the ability to perform the exercises or evaluations
  • Diabetes or rheumatic diseases
  • History of deep venous thrombosis
  • severe cardiovascular disease

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

Бельгия · 2 центра
  • Ghent University — Ghent
  • Ghent University Hospital — Ghent

Идентификаторы

NCT: NCT07131787 · ONZ-2025-0152

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗