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Идёт набор NCT07412184

Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury

Без фазы С лечением Rotator Cuff Tear

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: Wearable device rehabilitation, Offline Traditional Rehabilitation.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Tear. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.

Подробное описание

In this randomized controlled clinical study, patients with unilateral rotator cuff tears were included. Starting from the fifth week after surgery, they were randomly assigned to either an online wearable device training group or an offline traditional rehabilitation group, with analyses conducted through functional tests and assessments. The study investigated the impact of wearable device rehabilitation on functional recovery in patients with rotator cuff tears and compared it with offline traditional rehabilitation to verify its efficacy.

Вмешательства

  • Устройство Wearable device rehabilitation
    Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.
  • Другое Offline Traditional Rehabilitation
    Offline Traditional Rehabilitation

Первичные конечные точки

  • Joint range of motion [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Upper Limb Closed-Chain Stability Test [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • FMS Shoulder Mobility Test [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Isometric Strength Test [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Surface electromyography [Срок оценки: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative.]
Вторичные конечные точки (3)
  • Constant- Murley score [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • American Shoulder and Elbow Surgeon's Form [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Western Ontario Rotator Cuff Index [Срок оценки: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]

Критерии участия

Критерии включения

  • Age ≥18 years;
  • First-time rotator cuff injury surgery and received surgical treatment at Peking University Third Hospital;
  • MRI shows a tear with a maximum diameter <3 cm, confirmed by at least three musculoskeletal rehabilitation radiologists;
  • Possess a mobile device with internet access (e.g., smartphone or tablet) capable of using mobile applications;
  • Able to complete the planned study and follow-ups within 6 months after discharge;
  • No visual, hearing, cognitive, or communication impairments;
  • Able to provide informed and valid consent to participate in the study.

Критерии исключения

  • Presence of serious cardiovascular or cerebrovascular diseases, or cervical spondylosis with nerve damage;
  • Presence of cognitive impairment or vision problems;
  • Stroke, rheumatic disease, neurological disorders, or diseases limiting overall physical function or cardiopulmonary function within the past 2 years;
  • No prior history of shoulder joint injury, and having undergone other surgeries within the past 6 months;
  • Patients who cannot complete the entire cycle or drop out midway;
  • Presence of serious postoperative complications, such as wound infection, venous thromboembolism, etc.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07412184 · M20250763

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗