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Completed

NCT Number: NCT02734225

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Recovery

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

Other

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

Dynamometric Platform Training

Other

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

Primary outcomes

  1. Berg Balance Scale

    Time frame: 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 outcomes

  1. Functional Reach (cm)

    Time frame: 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

  2. Timed Up and Go Test (s)

    Time frame: 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

  3. Romberg Tests

    Time frame: 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

  4. Knee Range of Mobility (º)

    Time frame: Change from baseline (two weeks after intervention) to after four weeks of training

    Knee Range of Mobility (Flexion, Extension) in degrees

  5. Kendall and Lovet scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Instituto de Investigacion Sanitaria INCLIVA

Registry information

Official study title

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

Acronym: TKA_DP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2016
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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