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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Functional Recovery; Other: Balance Training; Other: Dynamometric Platform Training

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: INCLIVA
• Investigators: Principal Investigator: Sergio Roig-Casasús, Dr, University of Valencia

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: rehabilitation; total knee replacement; total knee arthroplasty; physical therapy; balance
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DP_Balance_TKA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED