Osteoarthritis, KneeNCT06220565
Evaluation of Product Effectiveness of the Intervention for Patients With Knee Osteoarthritis
A study testing sensor and wearable device "Graded Exercise", exercise and Educational Manual in people with Osteoarthritis, Knee and Product Use Issue, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Product Use Issue, Sports Physical Therapy
- What is being tested?
- sensor and wearable device "Graded Exercise", exercise and Educational Manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- sensor and wearable device "Graded Exercise", exercise, Educational Manual
- Keywords
- Older adults, Osteoarthritis, Sports Rehabilitation, Product Design
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensor and wearable device "Graded Exercise"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.
exerciseOther
exercise
Educational ManualOther
Educational Manual
| Study group | Role | What they receive |
|---|---|---|
| Products for graded exercise interventions "Graded Exercise" | Experimental | 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. Receives: Device: sensor and wearable device "Graded Exercise"; Other: exercise |
| Education group | Placebo comparator | Educational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee Receives: Other: exercise; Other: Educational Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (1)
Affective State Depression Rating Scale for Older Adults
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jun 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Dian, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jianan Zhao, Dr, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220565
- Sponsor's protocol ID
- MDH0002
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu D, Zhao J, Wu T, Zhu B, Wang M, Han T. Effects of a Computer Vision-Based Exercise Application for People With Knee Osteoarthritis: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 May 12;13:e63022. doi: 10.2196/63022.
PubMed 40354624Wu 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.
PubMed 39605293
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Product Effectiveness of a Graded Exercise Intervention for Patients With Knee Osteoarthritis in a Community Scenario
- ClinicalTrials.gov ID
- NCT06220565
- Acronym / sponsor ID
- MDH0002
- Keywords
- Older adults, Osteoarthritis, Sports Rehabilitation, Product Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Products for graded exercise interventions "Graded Exercise" | Experimental | Device: sensor and wearable device "Graded Exercise", Other: exerciseThrough 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 comparator | Other: exercise, Other: Educational ManualEducational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Products for graded exercise interventions "Graded Exercise" |
| exerciseexercise | Other | Education group, Products for graded exercise interventions "Graded Exercise" |
| Educational ManualEducational Manual | Other | Education group |
Primary outcome
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.
1 secondary outcome
Affective State Depression Rating Scale for Older Adults
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 40354624Zhu D, Zhao J, Wu T, Zhu B, Wang M, Han T. Effects of a Computer Vision-Based Exercise Application for People With Knee Osteoarthritis: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 May 12;13:e63022. doi: 10.2196/63022.
- Derived from this study: PubMed 39605293Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Zhao, Dr principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensor and wearable device "Graded Exercise", exercise and Educational Manual in people with Osteoarthritis, Knee and Product Use Issue, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06220565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.