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临床试验/NCT05290272
NCT05290272已完成不适用

Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive

Stanford University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Knee Injury and Osteoarthritis Outcomes Score

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of the 12-week ViFive program, a vision-based artificial intelligent digital care plan for chronic knee pain. ViFive digital care plan is delivered by a physical therapy team consisting of physical therapists and a personal coach. We aim to understand the safety and efficacy of this vision artificial intelligent based home exercise program.

详细描述

This study is recruiting patients who present with knee osteoarthritis and shoulder adhesive capsulitis through evaluation by the treating physician. A brief physical functional assessment will be conducted to ensure eligibility and assess for any safety concerns (e.g., minimum strength and capability to conduct basic rehabilitation exercises).

Once subject is enrolled and device is distributed and set up, participants will follow and complete the VIFive program on the device.

ViFive DCP (Digital Care Program) is a highly structured, protocolized, and individually tailored intervention consisting of personalized exercise therapy modules. ViFive DCP is delivered by a physical therapy team consisting of DPTs and a personal coach. The DCP consists of ten modules and its advancement will be determined by each patient's progress after the treatment team's review every week. The primary aim of ViFive DCP is to assist patients in recovering their appropriate daily physical activity level by strengthening the knee and educating proper interpretation of sensation rather than pain. ViFive DCP represents a mobile intervention platform utilizing vision-AI. Vision AI enables objective and precise exercise prescription along with transparent patient monitoring. As a platform, there is an interface for patients and clinicians. Each module consists of a specific exercise treatment plan, educational articles, and instructions to promote changes in daily life. Each of these modules has specific goals, and patients are able to follow a predefined sequence of modules. ViFive DCP includes illustration, voice guidance, and pose correction features of AI coach. During treatment, patients have regular contact with their personal coach through a message functioning (e.g., exercise progress, answers to questions, patient receives feedback from the coach, can ask the coach questions, etc). The coach provides continuous feedback on completed tasks and responds to concerns the patient may have. Weekly feedback on progress is also provided. In total, the coach spends approximately 12 hours per patient throughout treatment.

After completion of the program, device will be returned.

Participants are to complete questionnaires, consisting of KOOS, VAS, and surgery interest at baseline, 3-month, and 6-month. VAS will be used to assess changes in pain level. KOOS will be used to assess knee functional outcome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.Age 18-60 years old
  • Diagnosis of adhesive capsulitis or
  • Diagnosis of knee osteoarthritis

排除标准

  • Age <18 or >60 years old
  • acute injuries or recent surgeries to the knee or shoulder

结局指标

主要结局

Knee Injury and Osteoarthritis Outcomes Score

时间窗: 6 months

Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). 100 indicating the best score, and 0 indicating the worst score.

Visual Analogue Scale

时间窗: 6 months

Patient reported outcome measure that reports pain intensity on a scale of 0-10 (10 being extreme pain and 0 no pain at all). 10 indicating the worst score and 0 indicating the best score.

次要结局

  • Surgery Interest(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugene Roh

Clinical Associate Professor

Stanford University

研究点 (2)

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