In-home versus hospital preoperative balance and proprioceptive training in patients undergoing TKR; rationale, design, and method of a randomized controlled trial
- PMID: 29221471
- PMCID: PMC5723092
- DOI: 10.1186/s12891-017-1887-4
In-home versus hospital preoperative balance and proprioceptive training in patients undergoing TKR; rationale, design, and method of a randomized controlled trial
Abstract
Background: Severe knee osteoarthritis, as well as the surgical procedure of total knee replacement that aims to reduce its symptoms, cause great deterioration on the proprioceptive system. Taking this fact into account, and considering that balance abilities positively influence the capacity to perform basic functional tasks, this trial aims to find the short and mid-term effects of a preoperative balance and proprioceptive training when conducted by patients undergoing total knee replacement. Along with the effects, it is intended to determine whether in-home based training can be as effective as hospital training. The results will help to conclude whether the possible benefits may outweigh the health costs.
Methods: Seventy-five participants will take part. The trial will include in-home and supervised hospital experimental training compared to a non-active control group in order to estimate the actual effect of the proposal against the benefits due exclusively to the surgical procedure. Interventions last 4 weeks prior to surgery, and the follow-up will be at 2w, 6w, and 1y following the operation. The primary outcomes are in agreement with the goals: self-reported functionality in terms of KOOS and overall balance in terms of the Berg Balance Scale. The secondary outcomes will include the measurements of static and dynamic balance abilities, pain, function, and quality of life.
Discussion: It is expected for the results of this trial to provide relevant information in order to decide if a specific intervention is cost-effective to be implemented in clinical practice.
Trial registration: Clinicaltrials.gov identifier NCT03100890 . Registered in April 4, 2017.
Keywords: Balance; Physiotherapy; Preoperative intervention; Proprioception; Sensorimotor; Total knee arthroplasty; Total knee replacement.
Conflict of interest statement
Ethics approval and consent to participate
The trial was approved by the Ethical Committee for Clinical Research and by the Scientific Committee of the Hospital Politécnico y Universitario de La Fe de Valencia (2016/0499). The authors certify that they will obtain all appropriate patient consent forms. In the form the patients will give their consent to participate and for clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
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