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

NCT ID: NCT02734225

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EXPERIMENTAL

Functional recovery Balance training

Group Type: EXPERIMENTAL

Functional Recovery

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Dynamometric Platform Training

Intervention Type: OTHER

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

CONTROL

Functional recovery Balance training Dynamometric Platform training

Group Type: ACTIVE_COMPARATOR

Functional Recovery

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Balance Training

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

Intervention Type: OTHER

Dynamometric Platform Training

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria INCLIVA

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Sergio Roig Casasus

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Roig-Casasús, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Other Identifiers

DP_Balance_TKA

Identifier Type: -

Identifier Source: org_study_id