CClinicalTrials.gg
CompletedNCT02995668PRE_TKR_BLCUpdated Nov 29, 2022

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

An interventional study of Strength-Function and Balance-Proprioception in Knee Osteoarthritis and Aging, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Aging
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 82 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • No intervention
    Control

    Non-active comparator

  • Active comparator
    Strength-Function

    Active comparator

    Other: Strength-Function

  • Experimental
    Balance-Proprioception

    Experimental

    Other: Strength-Function · Other: Balance-Proprioception

Interventions

  • OtherStrength-Function

    Preoperative functional and strength capabilities training.

  • OtherBalance-Proprioception

    Preoperative proprioceptive and balance capabilities training

06

What researchers measure

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    http://www.koos.nu/KOOSusersguide2012.pdf

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  2. 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

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

Secondary outcomes

  1. 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

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  2. Knee Range of Mobility (ROM)

    Knee Range of Mobility (Flexion, Extension) in degrees

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  3. Quadriceps Strength

    Electronic dynamometer in Newton

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  4. Euro Quality of Life 5 Dimension (Euro-QoL-5D)

    Quality of Life assessment

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

07

Study locations

1 site
  • University of Valencia
    Valencia, 46010, Spain
08

References and documents

Publications

  • 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. PubMed 32342139 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02995668
Lead sponsor
University of Valencia
Collaborators
Hospital Clínico Universitario de Valencia
Responsible party
Jose María Blasco Igual (PhD, University of Valencia) — Principal investigator
First posted
Dec 16, 2016
Start date
Jan 17, 2017
Primary completion
Sep 18, 2018
Completion
Sep 1, 2019
Last update
Nov 29, 2022

Study contacts

Jose M Blasco, PhD
principal investigator · University of Valencia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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