Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus

Официальное название

Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus: A Prospective, Randomized Controlled Trial Protocol

Обзор

This study is designed as a single-center, prospective, randomized controlled trial. The aim of this clinical trial is to evaluate the effectiveness, safety, and feasibility of a wearable device-based telerehabilitation approach for postoperative recovery in patients undergoing arthroscopic surgery for discoid meniscus injury. The core research questions to be addressed are: to compare the effects of two postoperative rehabilitation methods (clinic rehabilitation versus telerehabilitation) on knee function scores in patients after arthroscopic discoid meniscus surgery; and to compare patient satisfaction, rehabilitation adherence, and clinical benefit between the two postoperative rehabilitation interventions. Participants will be randomly assigned to either the clinic rehabilitation group or the telerehabilitation group. The telerehabilitation group will undergo digital rehabilitation using wearable devices and a telerehabilitation system postoperatively, while the clinic rehabilitation group will receive one-on-one exercise rehabilitation sessions in an outpatient setting. Both groups will be followed up for six months postoperatively, with assessments scheduled at multiple time points: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively. The primary outcome measures focus on clinical functional improvement, including range of motion (ROM), weight-bearing progression, muscle strength, swelling, limb circumference, functional scores (Visual Analog Scale \[VAS\] for pain, Tegner activity scale, International Knee Documentation Committee \[IKDC\] subjective form, Lysholm knee score, Ikeuchi meniscus postoperative functional score), three-dimensional gait analysis parameters, and return-to-sports evaluation. Secondary outcomes include patient satisfaction, rehabilitation adherence, imaging findings, and complication assessment.

Вмешательства

• Другое Telerehabilitation intervention based on wearable devices
  This model integrated 5G network connectivity, mobile terminal applications, and wearable devices, enabling patients to perform rehabilitation exercises under real-time video and audio guidance. Patients underwent systematic telerehabilitation training assisted by wearable devices, following the same rehabilitation protocol as the on-site rehabilitation group. The patients installed the software on their smartphones and received a 24-week daily exercise program through the software platform. The
• Другое Clinic rehabilitation
  Patients in the on-site rehabilitation group attended outpatient follow-up visits at 2, 6, 12, and 24 weeks postoperatively. During these visits, they received one-on-one, face-to-face systematic exercise rehabilitation training and guidance from a uniformly trained rehabilitation therapist, with at least one session per time point, each lasting 40 minutes. After mastering the essential techniques of the prescribed exercises, patients continued rehabilitation at home independently according to t

Первичные конечные точки

• Lysholm knee scoring scale [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• Visual Analog Scale [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• IKDC Subjective Knee Evaluation Form [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• Tegner score [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• Three-dimensional gait analysis [Срок оценки: preoperatively, and at 24 weeks postoperatively.]
• Knee range of motion [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• Limb Circumference [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• Muscle Strength [Срок оценки: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.]
• Return to Sport Assessment [Срок оценки: at 24 weeks postoperatively]

Вторичные конечные точки (4)

• MRI [Срок оценки: preoperatively and at 24 weeks postoperatively.]
• Patient Satisfaction Questionnaire [Срок оценки: at 24 weeks postoperatively]
• Rehabilitation Adherence [Срок оценки: From preoperatively to 24 weeks postoperatively]
• X-ray [Срок оценки: preoperatively and at 24 weeks postoperatively.]

Критерии участия

Критерии включения

• 1.Aged between 10 and 60 years.
• 2.Diagnosed with a discoid meniscus injury, confirmed by both magnetic resonance imaging (MRI) and arthroscopy.
• 3.Underwent arthroscopic partial meniscectomy (saucerization) with concomitant suture repair.
• 4.Willing to participate in the clinical trial and comply with the follow-up protocol.

Критерии исключения

• 1.Presence of concomitant injuries in the same knee, such as ligament tears, fractures, or cartilage lesions.
• 2.Kellgren \& Lawrence osteoarthritis grade greater than II.
• 3.History of trauma or surgery in other weight-bearing joints of the lower limb (e.g., ankle ligament tears, osteonecrosis of the femoral head) that could indirectly affect knee joint loading and movement.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07549867 · 2026（399）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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