TKA_DP: Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT02734225

Collaborator

INCLIVA (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Functional Recovery Other: Balance Training Other: Dynamometric Platform Training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXPERIMENTAL Functional recovery Balance training	Other: Functional Recovery Rehabilitation protocol based on muscle strengthening with isometric, isotonic and counter-resistance with progressive load exercises. Intervention consisted of warm-up phase with passive, active-assisted and active movements, and a work-out phase Other: Balance Training Balance and proprioception training using parallel bars, unstable plates, ramps and stairs Other: Dynamometric Platform Training Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases
Active Comparator: CONTROL Functional recovery Balance training Dynamometric Platform training	Other: Functional Recovery Rehabilitation protocol based on muscle strengthening with isometric, isotonic and counter-resistance with progressive load exercises. Intervention consisted of warm-up phase with passive, active-assisted and active movements, and a work-out phase Other: Balance Training Balance and proprioception training using parallel bars, unstable plates, ramps and stairs

Arm

Intervention/Treatment

Experimental: EXPERIMENTAL

Functional recovery Balance training

Other: Functional Recovery

Rehabilitation protocol based on muscle strengthening with isometric, isotonic and counter-resistance with progressive load exercises. Intervention consisted of warm-up phase with passive, active-assisted and active movements, and a work-out phase

Other: Balance Training

Balance and proprioception training using parallel bars, unstable plates, ramps and stairs

Other: Dynamometric Platform Training

Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases

Active Comparator: CONTROL

Functional recovery Balance training Dynamometric Platform training

Other: Functional Recovery

Other: Balance Training

Balance and proprioception training using parallel bars, unstable plates, ramps and stairs

Outcome Measures

Primary Outcome Measures

Berg Balance Scale [Change from baseline (two weeks after intervention) to after four weeks of training]
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

Secondary Outcome Measures

Functional Reach (cm) [Change from baseline (two weeks after intervention) to after four weeks of training]
Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position
Timed Up and Go Test (s) [Change from baseline (two weeks after intervention) to after four weeks of training]
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
Romberg Tests [Change from baseline (two weeks after intervention) to after four weeks of training]
Total score achieved with open and closed eyes and on firm surface
Knee Range of Mobility (º) [Change from baseline (two weeks after intervention) to after four weeks of training]
Knee Range of Mobility (Flexion, Extension) in degrees
Kendall and Lovet scale [Change from baseline (two weeks after intervention) to after four weeks of training]
Muscle Balance estimated with with Kendall and Lovet scale (score from 0 to 5)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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