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

Shanghai Jiao Tong University School of Medicine

Status: Active, not recruiting

Conditions: Product Use Issue; Sports Physical Therapy; Osteoarthritis, Knee

Treatments: Other: exercise; Other: Educational Manual; Device: sensor and wearable device "Graded Exercise"

Study type: Interventional

Funder types: Other

Identifiers

NCT06220565

MDH0002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Products for graded exercise interventions "Graded Exercise"

Experimental group

Description:

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.

Treatment:

Device: sensor and wearable device "Graded Exercise"

Other: exercise

Education group

Placebo Comparator group

Description:

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

Treatment:

Other: Educational Manual

Other: exercise