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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Device: knee brace

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 406040
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New brace; wearing a new knee brace for 4weeks	Device: 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.
Sham Comparator: Traditional knee brace; wearing a traditional knee brace for 4weeks	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index	up to 16 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: CMUH-113-REC3-182; china medical university (Other Identifier: china medical university and hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No