Clinical trial NCT02734225: Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty
Official title: Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: total knee replacement
total knee arthroplasty
rehabilitation
physical therapy
balance
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: INCLIVA
First posted: 2016-04-12
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Change from baseline (two weeks after intervention) to after four weeks of training
Secondary outcomes:
measure: Functional Reach (cm)
timeFrame: Change from baseline (two weeks after intervention) to after four weeks of training
measure: Timed Up and Go Test (s)
timeFrame: Change from baseline (two weeks after intervention) to after four weeks of training
measure: Romberg Tests
timeFrame: Change from baseline (two weeks after intervention) to after four weeks of training
measure: Knee Range of Mobility (º)
timeFrame: Change from baseline (two weeks after intervention) to after four weeks of training
measure: Kendall and Lovet scale
timeFrame: Change from baseline (two weeks after intervention) to after four weeks of training
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Sergio Roig-Casasús, Dr
role: PRINCIPAL_INVESTIGATOR
References: