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

Primary Purpose

Knee Osteoarthritis, Aging

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Strength-Function
Balance-Proprioception
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Strength-Function

Balance-Proprioception

Arm Description

Non-active comparator

Active comparator

Experimental

Outcomes

Primary Outcome Measures

Knee injury and Osteoarthritis Outcome Score (KOOS)
http://www.koos.nu/KOOSusersguide2012.pdf
Berg Balance Scale (BBS)
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

Secondary Outcome Measures

Timed Up and Go Test (TUG)
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
Knee Range of Mobility (ROM)
Knee Range of Mobility (Flexion, Extension) in degrees
Quadriceps Strength
Electronic dynamometer in Newton
Euro Quality of Life 5 Dimension (Euro-QoL-5D)
Quality of Life assessment

Full Information

First Posted
December 11, 2016
Last Updated
November 28, 2022
Sponsor
University of Valencia
Collaborators
Hospital Clínico Universitario de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT02995668
Brief Title
Effects of Specific Balance Training Prior TKR Surgery in the Early Postoperative Outcomes
Acronym
PRE_TKR_BLC
Official Title
Influencia de un Entrenamiento Preoperatorio de propiocepción y Equilibrio en Pacientes Con Artrosis Severa de Rodilla en Espera Para la intervención de Artroplastia Total
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Hospital Clínico Universitario de Valencia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-active comparator
Arm Title
Strength-Function
Arm Type
Active Comparator
Arm Description
Active comparator
Arm Title
Balance-Proprioception
Arm Type
Experimental
Arm Description
Experimental
Intervention Type
Other
Intervention Name(s)
Strength-Function
Intervention Description
Preoperative functional and strength capabilities training.
Intervention Type
Other
Intervention Name(s)
Balance-Proprioception
Intervention Description
Preoperative proprioceptive and balance capabilities training
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
http://www.koos.nu/KOOSusersguide2012.pdf
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Berg Balance Scale (BBS)
Description
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
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Knee Range of Mobility (ROM)
Description
Knee Range of Mobility (Flexion, Extension) in degrees
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Quadriceps Strength
Description
Electronic dynamometer in Newton
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Euro Quality of Life 5 Dimension (Euro-QoL-5D)
Description
Quality of Life assessment
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Blasco, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32342139
Citation
Dominguez-Navarro F, Silvestre-Munoz A, Igual-Camacho C, Diaz-Diaz B, Torrella JV, Rodrigo J, Paya-Rubio A, Roig-Casasus S, Blasco JM. A randomized controlled trial assessing the effects of preoperative strengthening plus balance training on balance and functional outcome up to 1 year following total knee replacement. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):838-848. doi: 10.1007/s00167-020-06029-x. Epub 2020 Apr 27.
Results Reference
derived

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

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