Effects of Specific Balance Training Prior TKR Surgery in the Early Postoperative Outcomes (PRE_TKR_BLC)

November 28, 2022 updated by: Jose María Blasco Igual, University of Valencia

Influencia de un Entrenamiento Preoperatorio de propiocepción y Equilibrio en Pacientes Con Artrosis Severa de Rodilla en Espera Para la intervención de Artroplastia Total

Knee osteoarthritis is one of the most common pathologies in old people, and the leading cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility, functional impairment and proprioceptive deficit. When conservative treatments fail to control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly because of its efficacy on pain relief. In recent decades, this surgical procedure has been soared, and it has also aroused the interest of researches about the patients' outcomes after surgery.

Despite the TKR results in good reported outcomes, after surgery patients may manifest persistent pain and problems affecting to their functionality, stability, walking speed, proprioception, motor control, risk of falling and therefore to their quality of life. In more than a third of the cases, those deficiencies may be extended after surgery from six months to one year, when subjects use to achieve the plateau functional values.

Traditional rehabilitation programs have been usually focused on improving muscle strength of the lower limbs as well as the functionality with specific exercises to achieve this purpose, and to a lesser extent on balance and proprioception exercises. Evidence supports this approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the most important factors for a complete rehabilitation, since benefits of proprioceptive and balance trainings may range from better stability and motor control, improvements in both static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that the combination of traditional functional rehabilitation together with balance training may help to restore functional deficits to a larger extent than usual therapy, and based on a systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016), sensori-motor training is an acceptable adjust to usual physiotherapy care .

Looking into the effect of preoperative trainings or education before TKR surgery, it is aimed at improving the physical function, but also managing the expectations of the surgery for a better recovery. There is from low to moderate evidence about the effects of TKR pre-interventional training programs, and some authors have argued that the effects are too small to be consider clinically relevant.

In general, the preoperative program is usually focused on functional and strengthening exercises. Despite of proprioception is used in the clinical practice for the prevention and recovery of many orthopedics injuries, the amount of evidence about the effects of proprioceptive training programs for knee and hip replacement is not large, few works compares pre-habilitation and post-rehabilitation programs, and there is not systematically reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional training programs.

In this framework, this aimed at evaluating the effects of specific-task oriented proprioceptive and balance training programs when conducted by patients undergoing TKR before and after surgery, and will compare these effects to the outcomes achieved with traditional strength-functional programs, as well as to no specific prehabilitation training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 60 and 80.
  • Subjects with severe knee osteoarthritis that have not been operated before.
  • Patients will be operated with the same total replacement prosthesis and same surgical procedure.
  • The score in Berg scale must be greater than 21, indicating a medium-low risk of falling.
  • The score 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 with morphological alterations hip or ankle (also knee).
  • Patient with suspected deep vein thrombosis or post-surgical infection of the operated knee.
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Non-active comparator
Active Comparator: Strength-Function
Active comparator
Other: Strength-Function
Preoperative functional and strength capabilities training.
Experimental: Balance-Proprioception
Experimental
Other: Strength-Function
Preoperative functional and strength capabilities training.
Other: Balance-Proprioception
Preoperative proprioceptive and balance capabilities training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
http://www.koos.nu/KOOSusersguide2012.pdf
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Berg Balance Scale (BBS)
Time Frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Overall state of balance. 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 to the week before surgery, 2 and 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test (TUG)
Time Frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
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 to the week before surgery, 2 and 6 weeks after surgery
Knee Range of Mobility (ROM)
Time Frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Knee Range of Mobility (Flexion, Extension) in degrees
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Quadriceps Strength
Time Frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Electronic dynamometer in Newton
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Euro Quality of Life 5 Dimension (Euro-QoL-5D)
Time Frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Quality of Life assessment
change from baseline to the week before surgery, 2 and 6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Hospital Clínico Universitario de Valencia

Investigators

  • Principal Investigator: Jose M Blasco, PhD, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRE_ATR_BALANCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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