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临床试验/NCT06347523
NCT06347523终止不适用

The Application of a Preoperative Rehabilitation Program Based on Virtual Reality (VR) Technology in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

First Affiliated Hospital of Shantou University Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
100
试验地点
1
主要终点
knee joint range of motion

研究概览

简要总结

Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group.

详细描述

The control group will receive standard nursing care, while the experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology. This program will include patient assessments, personalized exercise prescriptions, and VR-based educational videos covering psychological support, nutritional guidance, and exercise instructions.

Patients in the experimental group will use VR headsets for preoperative and postoperative interactive training sessions, as well as for viewing postoperative educational videos. The intervention will start upon admission and will continue until discharge.

Primary outcome measures will include knee joint range of motion and the Lysholm knee function score. Secondary measures will encompass anxiety, depression, pain scores, activities of daily living, time to ambulation, postoperative complications, and patient satisfaction.

Statistical analysis will be conducted to compare outcomes between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals eligible for inclusion in the study are those who undergo their initial anterior cruciate ligament (ACL) reconstruction surgery, aged between 18 and 60 years, possess adequate hearing and vision, have clear consciousness, and demonstrate proficient language communication skills.

排除标准

  • Individuals with cognitive impairments, severe hearing or vision impairments, limb paralysis, or non-compliance with the experiment will be excluded from participation.

结局指标

主要结局

knee joint range of motion

时间窗: through study completion, an average of 6 months

This refers to the bending of the knee joint, bringing the heel toward the buttocks

Lysholm knee function score

时间窗: through study completion, an average of 6 months

The Lysholm knee function score typically includes a series of questions or items that ask the patient to rate their ability to perform various activities and movements involving the knee joint. These activities may include walking, running, squatting, climbing stairs, and other functional tasks. Patients are asked to rate their knee function and any associated symptoms such as pain or instability. The scoring system for the Lysholm knee function score can vary, but it often ranges from 0 to 100, with higher scores indicating better knee function and lower scores suggesting greater impairment or limitations.

次要结局

  • SAS self-rating anxiety scale scale(through study completion, an average of 6 months)
  • SDS self-rating depression scale scale(through study completion, an average of 6 months)
  • Barthel Index for basic activities of daily living(through study completion, an average of 6 months)
  • time to first ambulation post-surgery(through study completion, an average of 6 months)
  • Visual Analog Scale pain score(through study completion, an average of 6 months)

研究者

发起方
First Affiliated Hospital of Shantou University Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeshan Chen

Nurse Researcher

First Affiliated Hospital of Shantou University Medical College

研究点 (1)

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