Assessment of a Knee Brace in Patients With Osteoarthritis
This trial is active, not recruiting.
|Sponsor||Irmandade da Santa Casa de Misericordia de Sao Paulo|
|Start date||November 2015|
|End date||March 2016|
|Trial size||108 participants|
|Trial identifier||NCT02706106, SCMAA01|
It is a controlled clinical trial randomized, double-blind evaluator. Will be considered eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee osteoarthritis and who sought physical therapy treatment.
Patients will be randomized by a number sequence generated by a computer using Microsoft Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who will not attend the study.Patients will be divided into two groups: group with knee patellar hole or group without knee patellar hole. Shortly after the selection of the knee, the patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type of knee brace that it would use.
Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator ''blind '' regarding the type of knee brace that will be used.
Two investigators will carry out the data collection. The first evaluator will collect information on the clinical characteristics of patients, including evaluation form, numerical pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test that measures the basic mobility of movement and test walking eight meters, whose purpose is to measure the time that the individual takes to walk a distance of eight meters.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Change on pain sensation
time frame: Pain will be measured before and right after or maximum five minutes after wearing the brace knee
Change on leg function
time frame: Leg function will be measured before and right after or maximum five minutes after wearing the brace knee
Change on agility
time frame: Agility will be measured before and right after or maximum five minutes after wearing the brace knee
Male or female participants from 40 years up to 60 years old.
Inclusion Criteria: - individuals of both sexes - aged 40 -60 - at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology, - pain above four points in the visual analogue scale (VAS) - diagnosed with knee osteoarthritis - no physical therapy treatment prior Exclusion Criteria: - neurological impairment - partial or total knee prosthesis - cardio-respiratory diseases - pregnant women - individuals who failed to perform the tests proposed
|Official title||Assessment of a Knee Brace in Patients With Osteoarthritis|
|Principal investigator||Marco N Added, MSc|
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