Evaluation of Product Effectiveness of the Intervention for Patients With Knee Osteoarthritis
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedApril 30, 2026
January 1, 2024
11 months
January 12, 2024
April 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
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 Outcomes (1)
Affective State Depression Rating Scale for Older Adults
10 minutes
Study Arms (2)
Products for graded exercise interventions "Graded Exercise"
EXPERIMENTALThrough 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.
Education group
PLACEBO COMPARATOREducational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dian Zhu
Shanghai, Shanghai Municipality, 200140, China
Related Publications (1)
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.
PMID: 39605293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianan Zhao, Dr
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2024
First Posted
January 24, 2024
Study Start
June 1, 2023
Primary Completion
May 1, 2024
Study Completion
June 1, 2024
Last Updated
April 30, 2026
Record last verified: 2024-01