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临床试验/NCT07066514
NCT07066514撤回不适用

Effectiveness of Exercises Supervised Via an Artificial Intelligence-Supported Mobile Application in Patients With Knee Osteoarthritis

Uludag University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
60
试验地点
2
主要终点
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

研究概览

简要总结

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-supported mobile application that supervises home-based exercise programs in patients with knee osteoarthritis. A total of 80 participants aged 40 to 80 will be randomly assigned to one of two groups: a mobile application exercise group or a home exercise booklet group. Both groups will receive the same standardized stretching, strengthening, and range of motion exercises designed for knee osteoarthritis. The mobile app provides real-time feedback and supervision using the device's camera and artificial intelligence algorithms to track and guide exercise performance.

Participants in the app group will perform exercises with supervision via the app interface, while the control group will follow the same exercises using printed instructions. Both groups will exercise 3 to 4 times per week for 4 weeks. The study will compare pain levels, physical function, and balance before and after the intervention using validated outcome measures such as the WOMAC Index and the Visual Analog Scale.

This study may help determine whether AI-supported digital tools can improve exercise adherence and outcomes in patients with knee osteoarthritis.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 40 and 80 years
  • Diagnosed with knee osteoarthritis according to ACR criteria
  • Referred to physical therapy by a physician for knee osteoarthritis
  • Able to use a smartphone or tablet
  • Having regular access to the internet
  • Voluntarily agrees to participate in the study

排除标准

  • History of knee surgery or currently undergoing surgical treatment
  • Received physical therapy or rehabilitation for knee OA within the past 6 months
  • Lack of access to a mobile device or internet
  • Any neurological, cardiovascular, or musculoskeletal condition that prevents safe participation in exercise
  • Cognitive impairment or psychiatric disorder interfering with exercise adherence
  • Inability to follow instructions or use the mobile app interface
  • Any condition that would contraindicate participation in a home-based exercise program

研究组 & 干预措施

AI-Based Mobile Home Exercise Group

Experimental

干预措施: AI-Supervised Mobile Exercise Program (Behavioral)

Standard Home Exercise Group

Experimental

干预措施: Booklet-Guided Home Exercise Program (Behavioral)

结局指标

主要结局

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

时间窗: Baseline and Week 4

The WOMAC is a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items: 5 for pain, 2 for stiffness, and 17 for physical function. Each item is scored on a 5-point Likert scale (0 = none to 4 = extreme), with a total score range of 0 to 96. Higher scores indicate worse symptoms.

Visual Analog Scale (VAS)

时间窗: Baseline and Week 4

Change in pain severity measured by the Visual Analog Scale (VAS; range: 0-10; higher scores indicate worse pain) at baseline and at 6 weeks.

Timed Up and Go (TUG) Test

时间窗: Baseline and Week 4

Functional Reach Test (FRT)

时间窗: Baseline and Week 4

Single-Leg Stance Test

时间窗: Baseline and Week 4

Exercise Execution Accuracy Assessed by Mobile Application

时间窗: Before and during the 4-week intervention

Accuracy of exercise adherence detection by the AI algorithm compared to physiotherapist assessment (% agreement)

次要结局

未报告次要终点

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selim Mahmut GÜNAY

Asst Prof

Mustafa Kemal University

研究点 (2)

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