Knee Osteoarthritis Clinical Trial
— TKA_DPOfficial title:
Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica
Verified date | April 2016 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's proprioceptive system increasing instability. After total knee arthroplasty intervention, it is recommended that the patient performs a rehabilitation procedure to minimize deficits caused by surgery. In this job it is essential to insist on the importance of recovering balance after total knee arthroplasty intervention, and assess a specifically designed protocol to restore its function. An intervention which includes a dynamometric platform as a training method was proposed. The randomized clinical trial compared a control group that performed balance exercises on parallel bars, unstable plates, ramps and stairs against an experimental group that included dynamometric platforms training as a differentiator.
Status | Completed |
Enrollment | 69 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age between 65 and 85. - Subjects with knee osteoarthritis that have not been operated before. - Patients operated with the same total replacement prosthesis. - Patients operated with the same surgical procedure. - Time before intervention over 4 weeks. - Time to start rehabilitation after surgery must be less than 4 weeks. - The Result in Berg scale must be greater than 21, indicating a medium-low risk of falling. - the Result of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment. - Once the informed consent is read and explained, patients must accept and agree to participate in the study. Exclusion Criteria: - Patient does no accept sign the informed consent. - Patient with morphological alterations hip or ankle (also knee). - Patient that presents knee flexion out of the range between 70 ° and -20 ° because of the risk posed to suffer a fall. - Patient with suspected deep vein thrombosis. - Patient with post-surgical infection of the operated knee. - Patient with psychiatric disorders: depression, anxious syndrome, etc. - Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength - Patient with vestibular pathology that could interfere with the results of the test of balance |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Valencia | INCLIVA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Berg Balance Scale | Balance among older people with impairment in balance function by assessing the performance of functional tasks from the total score achieved in the 14 items test | Change from baseline (two weeks after intervention) to after four weeks of training | No |
Secondary | Functional Reach (cm) | Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position | Change from baseline (two weeks after intervention) to after four weeks of training | No |
Secondary | Timed Up and Go Test (s) | Dynamic balance assessment. Also points at the risk of falling. Time of getting up from a chair, walk three meters, come back and sit again, measured in seconds | Change from baseline (two weeks after intervention) to after four weeks of training | No |
Secondary | Romberg Tests | Total score achieved with open and closed eyes and on firm surface | Change from baseline (two weeks after intervention) to after four weeks of training | No |
Secondary | Knee Range of Mobility (º) | Knee Range of Mobility (Flexion, Extension) in degrees | Change from baseline (two weeks after intervention) to after four weeks of training | No |
Secondary | Kendall and Lovet scale | Muscle Balance estimated with with Kendall and Lovet scale (score from 0 to 5) | Change from baseline (two weeks after intervention) to after four weeks of training | No |
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