Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- VAS pain score
Study Overview
Brief Summary
The purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee OA.
Detailed Description
20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace will be recruited into this study. Another 20 subjects with comparable body height, weight, and sex will be served as a control group. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week). VAS pain score, WOMAC index, and SF-36 will be evaluated before the treatment, and 1 month, and 3 months after the start of treatment. Patients' satisfaction will be evaluated at 1 month, and 3 months after start of treatment. Patients' compliance and any adverse events due to wearing of the functional knee brace will also be reported. A 2-by-3, 2-way mixed-model analysis of variance, which had 1 between-subject factor (group: knee brace + PT and PT only) and 1 within subject factor (evaluation time:T0, T1, T2) , was performed. Pair-wise comparisons between groups were performed using an independent t test (if in normal distribution) or Mann-Whitney U test (if not in normal distribution). Investigators hypothesize that addition of a functional knee brace would improve rehabilitation outcome in subjects with knee OA.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •According to the American College of Rheumatology (American College of Rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to Kellgren and Lawrence X-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed Thruster Legacy's functional knee brace. The control group of patients with knee osteoarthritis same conditions, but dressed Thruster Legacy functional knee brace.
Exclusion Criteria
- •have undergone knee surgery
- •the lateral tibiofemoral joint severe (tibio-femoral joint) disease
- •serious knee ligament laxity
- •knee flexion contracture (flexion contracture) than 20 degrees
- •unable to walk
- •the skin of metal (aluminum) allergy
- •lower extremity vascular lesions or swelling
Arms & Interventions
wear a functional knee brace
20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)
Intervention: functional knee brace (Device)
no wear a functional knee brace
Another 20 subjects with comparable body height, weight, and sex. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)
Outcomes
Primary Outcomes
VAS pain score
Time Frame: 1 month
To the severity of the pain patients experience pain in itself to make a quantitative expression, assessment methods as follows: a horizontal line 10 cm in length, with zero as the most left office, on behalf of completely pain-free; the far right of the line can imagine the most severe pain, subjects were at rest and walking, according to their degree of sense of pain marked on the straight line. Reliability of this scale up to 0.94.
Secondary Outcomes
- WOMAC index(1 month)
- SF-36(1 month)