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Идёт набор NCT04149977

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Без фазы С лечением Lower Limb Injury

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: Physical Therapy with pressure cuff, Physical Therapy with placebo pressure cuff.
Кому может быть актуально
Состояния в реестре: Lower Limb Injury. Базовые параметры: 18 лет — 65 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
США
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

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study

Обзор

The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.

Подробное описание

The purpose is to restrict venous outflow with an inflatable cuff to create a high intensity environment increases muscle hypertrophy, thus promoting a more efficient form of rehabilitation. Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed. There are also audio and visual alarms that alert the user of under or over pressurization. The specific pressure will vary based on patient's tolerance and will stay consistent through each exercise. Thus far blood flow restriction therapy has been tested in patients with several pathologies but there is limited literature on its effect on lower limb extensor injuries.

Вмешательства

  • Поведенческое Physical Therapy with pressure cuff
    6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises.
  • Поведенческое Physical Therapy with placebo pressure cuff
    6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective.

Первичные конечные точки

  • Change in extensor strength of both legs [Срок оценки: Visit 1 Day 0]
  • Change in extensor strength of both legs [Срок оценки: Visit 3 week 6]
Вторичные конечные точки (4)
  • Change in recovery, muscle strength [Срок оценки: Visit 1 Day 0]
  • Change in recovery, muscle strength [Срок оценки: Visit 1 Week 6]
  • Change in Knee function [Срок оценки: Visit 1 Day 0]
  • Change in Knee function [Срок оценки: Visit 3 week 6]

Критерии участия

Критерии включения

  • Must be at least 18 years of age and younger than 65 years of age
  • ASA class I-II
  • Diagnosed with a lower limb extensor injury (quadriceps tendon rupture, patella tendon rupture, patella fracture)
  • Intention to receive physical therapy as standard of care

Критерии исключения

  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age or older than 65
  • Any patient considered a vulnerable subject
  • Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension
  • Concomitant lower extremity traumatic injuries, delaying or precluding the subject's ability to participate in the therapy
  • Immobile or use of mobile assistive device prior to injury
  • No prior extensor injuries
  • Patients with Sickle cell anemia or venous thromboembolism
  • Patients with cancer or Lymphectomies
  • Patients with increased intracranial pressure
  • Patients with intention to receive standard therapy and not the study therapy

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT04149977 · 19-01269

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗