The Effects of Knee Brace and Muscle Training on Osteoarthritis Patients

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.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 406040, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Knee pain on most days of the past month.
Presence of osteophytes on X-ray.
Synovial fluid that is clear, viscous, and contains fewer than 2,000 white blood cells/mL.
Age over 50 years.
Morning stiffness of the knee lasting less than 30 minutes.
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.

Treatment and study plan

Knee brace

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.

Primary outcomes

Western Ontario and McMaster Universities Osteoarthritis Index

Time frame: up to 16 weeks

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 24, 2025
Registry last updated: Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation