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STUDY PROTOCOL
Year : 2018  |  Volume : 3  |  Issue : 1  |  Page : 12-17

Effects of balance training prior total knee replacement surgery: study protocol for a randomized controlled trial


1 Department of Physiotherapy, University of Valencia; Group of Physiotherapy in the Ageing Process, University of Valencia; IRIMED Joint Research Unit La Fe Hospital - Universty of Valencia, Valencia, Spain
2 Department of Physiotherapy, University of Valencia, Valencia, Spain
3 Department of Physiotherapy, University of Valencia; Group of Physiotherapy in the Ageing Process, University of Valencia; Hospital Clínico y Universitario de Valencia, Valencia, Spain
4 Hospital Clínico y Universitario de Valencia; Department of Trauma and Orthopaedic Surgery, University of Valencia, Valencia, Spain
5 Department of Physiotherapy, University of Valencia; Group of Physiotherapy in the Ageing Process, University of Valencia; Hospital Universitario y Politécnico de La Fe, Valencia, Spain

Correspondence Address:
José-María Blasco
Department of Physiotherapy, University of Valencia; Group of Physiotherapy in the Ageing Process, University of Valencia; IRIMED Joint Research Unit La Fe Hospital - Universty of Valencia, Valencia
Spain
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.227050

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Background and objectives: Many functional limitations following total knee replacement are related to balance. This trial aims to determine the short and long-term effects on balance and functionality of a preoperative muscle enhancement program that includes a specifically oriented protocol of balance and proprioception training in the methods. Design: Prospective three-arm, randomized controlled trial. Methods: Seventy-eight participants will be will be recruited from Hospital Clínico y Universitario de Valencia in Spain, and randomly divided into three equal groups: a control group, a active comparator which performs a program for muscle enhancement preparatory for surgery, and a experimental group which additionally includes a program oriented to enhance balance and proprioception. Outcome measures: The primary outcome measures are overall balance assessed by the Berg Scale and self-reported functionality measured by the Knee Injury Osteoarthritis Outcome Function Score. Secondary outcomes include stability, dynamic and static balance abilities, anxiety-depression, and knee function. Outcomes will be assessed prior to intervention, 2 weeks, 6 weeks and 1 year after surgery. A cost effectiveness-analysis will be conducted based on the quality adjusted life years gained. Discussion: The results will help to appraise the early-postoperative effects in terms of balance and functionality. This research will also appraise the cost-effectiveness of the proposal, based on data extracted from long-term evaluations. Ethics and dissemination: The trial was approved by the Ethics and Scientific Committee of the Clinical and University Hospital of Valencia (26052016). Early-postoperative outcomes will be likely available by November 2018. Follow-up will be completed by the end of 2019. The results will be disseminated through workshops, peer-reviewed publications, and local and international conferences. Trial registration: ClinicalTrials.gov identifier: NCT02995668.


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