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临床试验/NCT06220565
NCT06220565进行中(未招募)不适用

Evaluation of Product Effectiveness of a Graded Exercise Intervention for Patients With Knee Osteoarthritis in a Community Scenario

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

研究概览

简要总结

Osteoarthritis of the knee is a common, chronic joint pathology that causes participants to suffer from pain, dysfunction, and reduced quality of life. The goal is to improve the quality of life and rehabilitation of patients by making rehabilitation exercises electronic and the system can be personalized to their specific conditions.

The focus of this study was on exercise interventions, and an interactive software was designed that combines repetitive motion and real-time feedback mechanisms. The software provides a series of rehabilitation movements that are specific to the characteristics of osteoarthritis of the knee in older adults, aiming to help participants gradually improve joint range of motion and muscle strength through exercise. The real-time feedback mechanism, on the other hand, monitors the participants' exercise status in real time through wearable devices, providing intuitive feedback to the participants to ensure that they perform the rehabilitation movements correctly, thus ensuring the scientificity and safety of the exercise.

In this study, investigators designed an exercise assessment and exercise intervention system for patients with knee osteoarthritis. In the exercise assessment part, the study combines several tools. First, the WOMAC scale was used to systematically assess patients' joint pain, stiffness, and dyskinesia. Second, physical function tests are used to assess the patient's overall exercise capacity, including indicators such as the number of sit-ups and rises. In addition, a wearable device was designed in this paper for real-time collection of knee angle information.

研究设计

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

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who meet the diagnostic criteria for osteoarthritis and are diagnosed with osteoarthritis of the knee;
  • Age greater than grade 18 years old;
  • Good communication and comprehension skills, able to understand the questionnaire clearly;
  • Informed consent and willingness to participate in the study.

排除标准

  • Patients with knee pain caused by other diseases;
  • Patients with severe knee pain and discomfort;
  • Patients with severe organic lesions of vital organs such as heart, brain and kidney;
  • Patients who have been treated with knee replacement.

结局指标

主要结局

University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

时间窗: 10 minutes

The WOMAC scale provides a better assessment of elderly and chronic patients. The scale consists of 3 dimensions: pain, morning stiffness, and dysfunction, with a total of 24 items, including 5 items for pain and 2 items for morning stiffness. The scale consists of 3 dimensions: pain, morning stiffness, and dysfunction, with a total of 24 items, of which 5 are for pain, 2 for morning stiffness, and 17 for dysfunction, and can be completed within 5-10 min.

次要结局

  • Affective State Depression Rating Scale for Older Adults(10 minutes)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Dian

Principal Investigator

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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