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Идёт набор NCT07623304

Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures

Без фазы С лечением Clinical Decision Support System

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: Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Basic Postoperative Care, Conventional Postoperative Care.
Кому может быть актуально
Состояния в реестре: Clinical Decision Support System. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study aims to develop a clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, based on evidence-based recommendations for postoperative exercise rehabilitation. The system is designed to provide individualized assessment and exercise interventions, monitor exercise behaviors, and deliver risk alerts, thereby promoting safe and standardized postoperative exercise training in OVCF patients. The ultimate objectives are to evaluate the feasibility and effectiveness of the system in increasing physical exercise participation, reducing sedentary time, and facilitating postoperative rehabilitation, without increasing fatigue or pain.

Вмешательства

  • Поведенческое Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures
    The experimental group first developed the functional modules of the OVCF exercise rehabilitation decision support system. Researchers were trained on participant selection, module use, and task allocation. Participants received operation demonstrations and a QR code for video guidance, then registered accounts and entered data. The system auto-captured baseline indicators, generated individualized exercise prescriptions, and pushed them for staff approval. Before and after each exercise session
  • Поведенческое Basic Postoperative Care
    All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
  • Поведенческое Conventional Postoperative Care
    Before discharge, patients received exercise rehabilitation training guidance from orthopedic specialist nurses and rehabilitation therapists and were given a rehabilitation training manual. They were instructed to scan the QR code in the manual to watch exercise training videos. The manual contained information including the goals, methods, frequency, intensity, and precautions of the exercise training.

Первичные конечные точки

  • IPAQ-L Scores [Срок оценки: The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.]
Вторичные конечные точки (3)
  • RPE Score [Срок оценки: The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.]
  • NRS Score [Срок оценки: The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.]
  • SUS Score [Срок оценки: The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.]

Критерии участия

Критерии включения

  • age between 18 and 55 years
  • diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
  • Surgical procedures performed by the same surgical team
  • willingness to comply with the study protocol and restrictions
  • availability of a home WiFi connection

Критерии исключения

  • lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
  • postoperative infection or revision surgery
  • presence of cauda equina syndrome
  • diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
  • coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513 — Nantong

Идентификаторы

NCT: NCT07623304 · HGao

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗