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

NCT ID: NCT06220565

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee Product Use Issue Sports Physical Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

sensor and wearable device "Graded Exercise"

Intervention Type DEVICE

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.

exercise

Intervention Type OTHER

exercise

Education group

Educational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee

Group Type PLACEBO_COMPARATOR

exercise

Intervention Type OTHER

exercise

Educational Manual

Intervention Type OTHER

Educational Manual

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

exercise

exercise

Intervention Type OTHER

Educational Manual

Educational Manual

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhu Dian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianan Zhao, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dian Zhu

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Wu T, Han T, Zhu D. Effects of Resistance Exercise Combined with Cognitive Intervention Therapy on Cognitive Decline: A Randomized Controlled Trial of a Cognitively Declining Elderly Population. Games Health J. 2025 Aug;14(4):281-294. doi: 10.1089/g4h.2024.0055. Epub 2024 Nov 27.

Reference Type DERIVED
PMID: 39605293 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDH0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.