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

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Knee; Product Use Issue; Sports Physical Therapy
• Interventions: Device: sensor and wearable device "Graded Exercise"; Other: Educational Manual; Other: exercise

• Registration Number: NCT06220565
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-02
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Products for graded exercise interventions "Graded Exercise"	sensor and wearable device "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.
Education group	Educational Manual	Educational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee
Products for graded exercise interventions "Graded Exercise"	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.
Education group	exercise	Educational Manual on Exercise Rehabilitation for Patients with Osteoarthritis of the Knee

Primary Outcome Measures

Name	Time	Method
University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	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.

Secondary Outcome Measures

Name	Time	Method
Affective State Depression Rating Scale for Older Adults	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.

Trial Locations

Locations (1)

Dian Zhu; 🇨🇳 Shanghai, Shanghai, China