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

Knee Osteoarthritis Clinical Trial

— TKA_DP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734225
• Other study ID #: DP_Balance_TKA
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: April 14, 2016
• Start date: March 2009
• Est. completion date: December 2012

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• Balance Training
Balance and proprioception training using parallel bars, unstable plates, ramps and stairs
• Dynamometric Platform Training
Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	INCLIVA

Outcome

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