The Effects of Knee Brace and Muscle Training on Osteoarthritis Patients

NCT ID: NCT07246109

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-12-31

Brief Summary

A new non-weight-bearing knee brace has been developed to correct abnormal alignment and reduce joint pressure, showing promising results in alleviating knee osteoarthritis symptoms compared to traditional braces. In addition, Blood Flow Restriction (BFR) training, which involves using pressure bands to simulate high-intensity exercise during low-intensity workouts, has been shown to enhance muscle strength.

This research will employ a randomized single-blind crossover trial to compare the effectiveness of the new and traditional braces, while also assessing BFR's impact on lower limb strength and knee function. This project will utilize various evaluation tools, including pain scales, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), participant satisfaction, muscle tension, Q-angle measurements, and joint range of motion. This project will assess the impacts of the new knee brace and BFR in alleviating pain and improving mobility.

Conditions

Osteoarthritis (OA) of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

New brace

wearing a new knee brace for 4weeks

Group Type: EXPERIMENTAL

knee brace

Intervention Type: DEVICE

This research will employ a randomized single-blind crossover trial to compare the effectiveness of the new and traditional braces. This project will utilize various evaluation tools, including pain scales, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), participant satisfaction, muscle tension, Q-angle measurements, and joint range of motion. This project will assess the impacts of the new knee brace and BFR in alleviating pain and improving mobility.

Traditional knee brace

wearing a traditional knee brace for 4weeks

Group Type: SHAM_COMPARATOR

knee brace

Intervention Type: DEVICE

This research will employ a randomized single-blind crossover trial to compare the effectiveness of the new and traditional braces. This project will utilize various evaluation tools, including pain scales, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), participant satisfaction, muscle tension, Q-angle measurements, and joint range of motion. This project will assess the impacts of the new knee brace and BFR in alleviating pain and improving mobility.

Interventions

knee brace

This research will employ a randomized single-blind crossover trial to compare the effectiveness of the new and traditional braces. This project will utilize various evaluation tools, including pain scales, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), participant satisfaction, muscle tension, Q-angle measurements, and joint range of motion. This project will assess the impacts of the new knee brace and BFR in alleviating pain and improving mobility.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Volunteers over 50 years of age who are able to fully comply with the study procedures.

Subjects diagnosed with unilateral or bilateral knee osteoarthritis by a physician based on X-ray findings and clinical symptoms.

Radiographic diagnosis is evaluated using the Kellgren and Lawrence Scale (K/L grade) as the radiographic assessment tool.

Clinical diagnosis follows the American College of Rheumatology (ACR, 1991) criteria, which include clinical symptoms in combination with radiographic or laboratory findings.

The diagnostic criteria are:

1. Knee pain on most days of the past month.

2. Presence of osteophytes on X-ray.

3. Synovial fluid that is clear, viscous, and contains fewer than 2,000 white blood cells/mL.

4. Age over 50 years.

5. Morning stiffness of the knee lasting less than 30 minutes.

6. Crepitus on knee motion.

Diagnosis of knee osteoarthritis is confirmed when any of the following combinations are present:

Exclusion Criteria

• Individuals with general contraindications to treatment, such as severe medical conditions, recent major trauma, or pregnancy.

Individuals with a history of substance abuse (including excessive alcohol consumption) that could affect pain perception.

Individuals with local skin infections, ulcers, or lesions in the treatment area.

Individuals who have undergone previous knee surgery or total knee arthroplasty.

Individuals with central or peripheral nervous system disorders.

Individuals with cognitive impairment who are unable to comply with the study procedures.

Individuals currently receiving other treatments for knee osteoarthritis.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

china medical university

Identifier Type: OTHER

Identifier Source: secondary_id

CMUH-113-REC3-182

Identifier Type: -

Identifier Source: org_study_id