Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder

Обзор

A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation

Подробное описание

Frozen Shoulder (FS), as a diffuse inflammatory disease, involves the glenohumeral joint, joint capsule, synovial tissues, and glenohumeral ligaments. Current management of FS includes conservative and surgical treatments. However, there remains room for improvement in the efficacy of conservative rehabilitation for FS. This study intends to enroll subjects diagnosed with Frozen Shoulder (FS) and conduct a randomized controlled trial to compare the safety and effectiveness of traditional rehabilitation versus remote intelligent rehabilitation for FS. Evaluations will include patient pain scores, shoulder joint function, and magnetic resonance imaging findings to observe the therapeutic effects of different interventions. This study aims to address how to enhance the rationality of FS patient management and identify the optimal rehabilitation treatment plan, thereby assisting FS patients in restoring daily living and motor functions as soon as possible.

Вмешательства

• Другое Artificial and intelligent combination of shoulder joint function exercise
  Rehabilitation therapist rehabilitation and intelligent rehabilitation are combined
• Другое Traditional rehabilitation training
  Shoulder joint function training is performed by a rehabilitation therapist
• Другое Intelligent rehabilitation training
  Shoulder joint rehabilitation training is carried out according to the intelligent rehabilitation system

Первичные конечные точки

• Constant-Murley Shoulder Assessment Score Scale [Срок оценки: Week 0、Week 4 and Week 8]

Вторичные конечные точки (5)

• Visual Analogue Scale [Срок оценки: Week 0、Week 4 and Week 8]
• Shoulder Range of Motion [Срок оценки: Week 0、Week 4 and Week 8]
• Shoulder muscle strength [Срок оценки: Week 0 、Week 4 and Week 8]
• Shoulder joint MRI [Срок оценки: Week 0 、Week 4 and Week 8]
• Exercise completion rate [Срок оценки: Week 0 、Week 4 and Week 8]

Критерии участия

Inclusion Criteria:① Subjects are aged between 40 and 60 years (inclusive), regardless of gender;

• Diagnosed with the adhesive phase of frozen shoulder by the Department of Sports Medicine, with patients potentially coming from different physicians;

• Have not participated in any other clinical trials within the past 3 months; ④ Patients voluntarily agree to participate in the clinical trial, sign the informed consent form, and are able to cooperate with clinical follow-up.

Exclusion Criteria:① Patients with combined cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, coagulation disorders, severe electrocardiogram abnormalities, etc.;

• Patients with local lesions in the affected shoulder or arm, such as skin damage, infection, tuberculosis, tumors, or skin diseases;

• Patients with poor physical condition who are unable to tolerate the intensity of rehabilitation training; ④ Patients with cognitive impairments who cannot undergo normal rehabilitation training, or other conditions deemed by the physician as unsuitable for trial participation; ⑤ Pregnant or breastfeeding women; ⑥ Patients with other shoulder conditions, such as rotator cuff tears or shoulder dislocation.

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: NCT07422714 · M20251134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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