The Effects of Knee Brace and Muscle Training on Osteoarthritis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: knee brace.
- Who it may be relevant to
- Registry conditions: Osteoarthritis (OA) of the Knee. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Western Ontario and McMaster Universities Osteoarthritis Index [Time frame: up to 16 weeks]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Taiwan · 1 center
- China Medical University — Taichung
Identifiers
NCT: NCT07246109 · CMUH-113-REC3-182 · china medical university