Evaluation of Product Effectiveness of the Intervention for Patients With Knee Osteoarthritis

April 25, 2026 updated by: Zhu Dian, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200140
        • Dian Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Products for graded exercise interventions "Graded Exercise"
Through digital means, patients are able to execute a personalized exercise program based on their rehabilitation plan and incorporate digital assessment methods to receive real-time feedback and recommendations for adjustments. By providing a personalized rehabilitation program and regular telecare, the aim is to focus on the patient's rehabilitation needs in a holistic manner.
Other: exercise
exercise
Device: sensor and wearable device "Graded Exercise"

The program plans to use rational mechanism to provide safe and targeted exercise interventions to patients at different stages of their lives through three aspects: education, motivation and feedback. Through real-time collection of knee function parameters, real-time feedback on the effect of exercise intervention, and tracking the changes in the functional status of patients' knee joints. On the basis of improving knee function, we further improve patients' compliance with exercise intervention.

Considering the community scenario, we plan to use sensors and wearable devices to realize the function of the knee joint on the basis of the existing technology. wearable devices to realize the digital assessment of knee function to reduce patient's time and cost and improve efficiency. At the same time, this digital assessment will provide a basis for decision-making for patient self-management.
Placebo Comparator: Education group
Educational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee
Other: exercise
exercise
Other: Educational Manual
Educational Manual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: 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.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affective State Depression Rating Scale for Older Adults
Time Frame: 10 minutes
A total of 30 entries represent the core of geriatric depression and include the following symptoms: low mood, decreased activity, irritability, withdrawal from painful thoughts, negative evaluations of the past, present, and future. Negative evaluations of the past, present and future.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Jianan Zhao, Dr, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDH0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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