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Идёт набор NCT06752551

Apprehension-based Training Compared With Standard Physical Therapy for Military Personnel Following Anterior Shoulder Dislocation - a Randomized Clinical Trial

Без фазы С лечением Anterior Shoulder Dislocation

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: Apprehension-based training, Standard physical therapy.
Кому может быть актуально
Состояния в реестре: Anterior Shoulder Dislocation. Базовые параметры: 18 лет — 39 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
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Официальное название

Apprehension-based Training Compared With Standard Physical Therapy Among Military Personnel Following Anterior Shoulder Dislocation

Обзор

The goal of this clinical trial is to determine if a new rehabilitation protocol (apprehension-based training), leads to better recovery after shoulder dislocation among military personnel. Participants will be randomly allocated to apprehension-based training or standard physical therapy. In apprehension-based training participants will train to control their shoulder under progressively more unstable conditions. Standard physical therapy will be provided based on the clinical judgment of the treating physical therapist The primary hypothesis is that participants undergoing apprehension-based training will experience a more complete recovery of function, better shoulder-related quality of life, and incur less recurrent dislocations.

Вмешательства

  • Поведенческое Apprehension-based training
    This intervention is comprised of the 3 phases: Static phase - Isometric (static) exercises performed in progressively greater shoulder apprehension ("instability") provoking conditions Dynamic phase: Isotonic (dynamic) exercises using shoulder apprehension-provoking movement patterns at a gradually increasing pace of movement. Neurocognitive phase: Dynamic phase exercises are continued at a high pace with the addition of cognitive tasks ("distractions"). The intervention is guided by a physi
  • Поведенческое Standard physical therapy
    Standard physical will be provided based on the assessment and judgment of the physical therapist. Intervention may include active exercises for increased shoulder mobility, muscle strength and neuromuscular control. Intervention may also include manual therapies such as massage, soft-tissue and joint mobilizations, dry needling, and electrophysiological modalities. No more than 8 individual sessions with a physical therapist will be provided over the course of treatment with some form of a home

Первичные конечные точки

  • Return to preinjury level of function [Срок оценки: 3 months following the end of intervention]
  • Western Ontario Shoulder Instability Index [Срок оценки: Baseline to end of intervention (10 weeks) and 1-year follow-up (62 weeks).]
  • Recurrence [Срок оценки: One year following the end of the intervention]
  • Supine moving apprehension test [Срок оценки: Baseline to end of intervention (10 weeks)]
Вторичные конечные точки (6)
  • Subjective shoulder value [Срок оценки: Baseline, end of intervention (10 weeks), and 1-year follow up (62 weeks)]
  • Tampa scale of kinesiophobia [Срок оценки: Baseline, end of intervention (10 weeks), and 1-year follow-up (62 weeks)]
  • Anterior apprehension test [Срок оценки: Baseline to end of intervention (10 weeks)]
  • Shoulder internal/external rotator muscle strength [Срок оценки: Baseline and end of intervention (10 weeks)]
  • Abdominal rollout [Срок оценки: Baseline and end of intervention (10 weeks)]
  • Heart rate variability [Срок оценки: Baseline and end of intervention (10 weeks).]

Критерии участия

Критерии включения

  • Age 18-39 years
  • Shoulder dislocation (primary or recurrent) documented by a medical practitioner (physician, military medic)
  • Positive anterior apprehension test
  • Gross shoulder muscle strength 3/5 or greater

Критерии исключения

  • Previous shoulder fracture, tendon tear, or shoulder surgery
  • Voluntary shoulder dislocation
  • Functional (Stanmore polar III) shoulder instability
  • Dislocation associated with a motor vehicle accident.
  • Diagnosis of rheumatoid arthritis, cancer (current), fibromyalgia, psychiatric disease)
  • Current pregnancy
  • Inability to attend at least one physical therapy session every 2 weeks.

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

Израиль · 1 центр
  • Israel Defense Forces Medical Corps — Be’er Ya‘aqov

Публикации

  • Rabin A, Noyman L, Yaakobi N, Kazum E. Apprehension-Based Training: A Novel Treatment Concept for Anterior Shoulder Dislocation - A Case Report. Int J Sports Phys Ther. 2024 Jul 1;19(7):888-897. doi: 10.26603/001c.118928. eCollection 2024. PMID 38966825
  • Rabin A, Chechik O, Olds MK, Uhl TL, Kazum E, Deutsch A, Citron E, Cohen T, Dolkart O, Bibas A, Maman E. The supine moving apprehension test-Reliability and validity among healthy individuals and patients with anterior shoulder instability. Shoulder Elbow. 2024 Feb;16(1):98-105. doi: 10.1177/17585732231170197. Epub 2023 Apr 18. PMID 38435037

Идентификаторы

NCT: NCT06752551 · 2388-2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗