The Effects of Knee Brace and Muscle Training on Osteoarthritis Patients

NCT07246109 | Enrolling By Invitation DMC

• 2 other identifiers: CMUH-113-REC3-182china medical university
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index

  up to 16 weeks

Study Arms (2)

New brace

EXPERIMENTAL

wearing a new knee brace for 4weeks

Device: knee brace

Traditional knee brace

SHAM COMPARATOR

wearing a traditional knee brace for 4weeks

Device: knee brace

Interventions

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.

New brace; Traditional knee brace

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

TW (1)