In-home versus hospital preoperative balance and proprioceptive training in patients undergoing TKR; rationale, design, and method of a randomized controlled trial

José-María Blasco, Celedonia Igual-Camacho, Sergio Roig-Casasús, José-María Blasco, Celedonia Igual-Camacho, Sergio Roig-Casasús

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.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participants flow chart

References

    1. Kane RL, Saleh KJ, Wilt TJ, et al. Total knee replacement. Evid Rep Technol Assess. 2003;86:1–8.
    1. Brandt KD, Dieppe P, Radin EL. Etiopathogenesis of osteoarthritis. Rheum Dis Clin N Am. 2008;34(3):531–559. doi: 10.1016/j.rdc.2008.05.011.
    1. Wada M, Kawahara H, Shimada S, Miyazaki T, Baba H. Joint proprioception before and after total knee arthroplasty. Clin Orthop. 2002;403:161–167. doi: 10.1097/00003086-200210000-00024.
    1. Mandeville D, Osternig LR, Chou L. The effect of total knee replacement surgery on gait stability. Gait Posture. 2008;27(1):103–109. doi: 10.1016/j.gaitpost.2007.02.009.
    1. Gstoettner M, Raschner C, Dirnberger E, Leimser H, Krismer M. Preoperative proprioceptive training in patients with total knee arthroplasty. Knee. 2011;18(4):265–270. doi: 10.1016/j.knee.2010.05.012.
    1. Lowe CJM, Barker KL, Dewey M, Sackley CM. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials. BMJ. 2007;335(7624):812. doi: 10.1136/.
    1. Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013;95(6):386–389. doi: 10.1308/003588413X13629960046435.
    1. Yoon RS, Nellans KW, Geller JA, Kim AD, Jacobs MR, Macaulay W. Patient education before hip or knee arthroplasty lowers length of stay. J Arthroplast. 2010;25(4):547–551. doi: 10.1016/j.arth.2009.03.012.
    1. Valkenet K, de Port V, Ingrid GL, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011;25(2):99–111. doi: 10.1177/0269215510380830.
    1. Gill SD, McBurney H. Does exercise reduce pain and improve physical function before hip or knee replacement surgery? A systematic review and meta-analysis of randomized controlled trials. Arch Phys Med Rehabil. 2013;94(1):164–176. doi: 10.1016/j.apmr.2012.08.211.
    1. Shimada H, Obuchi S, Kamide N, Shiba Y, Okamoto M, Kakurai S. Relationship with dynamic balance function during standing and walking. Am J Phys Med Rehabil. 2003;82(7):511–516.
    1. Barrett DS, Cobb AG, Bentley G. Joint proprioception in normal, osteoarthritic and replaced knees. Bone & Joint Journal. 1991;73(1):53–56.
    1. Moutzouri M, Gleeson N, Billis E, Panoutsopoulou I, Gliatis J. What is the effect of sensori-motor training on functional outcome and balance performance of patients’ undergoing TKR? A systematic review. Physiotherapy. 2016;102(2):136–144. doi: 10.1016/j.physio.2015.11.001.
    1. Huber EO, Roos EM, Meichtry A, de Bie RA, Bischoff-Ferrari HA. Effect of preoperative neuromuscular training (NEMEX-TJR) on functional outcome after total knee replacement: an assessor-blinded randomized controlled trial. BMC Musculoskelet Disord. 2015;16(1):101. doi: 10.1186/s12891-015-0556-8.
    1. Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014;73(6):1130–1137. doi: 10.1136/annrheumdis-2012-203135.
    1. Fernandes L, Roos EM, Overgaard S, Villadsen A, Sgaard R. Supervised neuromuscular exercise prior to hip and knee replacement: 12-month clinical effect and cost-utility analysis alongside a randomised controlled trial. BMC Musculoskelet Disord. 2017;18(1):5. doi: 10.1186/s12891-016-1369-0.
    1. Schwartz I, Kandel L, Sajina A, Litinezki D, Herman A, Mattan Y. Balance is an important predictive factor for quality of life and function after primary total knee replacement. J Bone Joint Surg Br. 2012;94(6):782–786. doi: 10.1302/0301-620X.94B6.27874.
    1. Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Canadian journal of public health= Revue canadienne de sante publique. 1991;83:7.
    1. Lobo A, Saz P, Marcos G, et al. Revalidación y normalización del mini-examen cognoscitivo (primera versión en castellano del mini-mental status examination) en la población general geriátrica. Med Clin. 1999;112(20):767–774.
    1. Faul F, Erdfelder E, Lang A, Buchner AG. Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–191. doi: 10.3758/BF03193146.
    1. Roig-Casasús S, Blasco JM, López-Bueno L, Blasco-Igual MC. Balance Training With a Dynamometric Platform Following Total Knee Replacement: A Randomized Controlled Trial. J Geriatr Phys Ther. 2017. doi:10.1519/JPT.0000000000000121. [Epub ahead of print].
    1. Brotzman SB, Manske RC. Clinical orthopaedic rehabilitation: an evidence-based approach-expert consult. Elsevier Health Sciences; 2011.
    1. Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002;82(4):372–82.
    1. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee injury and osteoarthritis outcome score (KOOS)—development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96. doi: 10.2519/jospt.1998.28.2.88.
    1. Podsiadlo D, Richardson S. The timed “up & go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–148. doi: 10.1111/j.1532-5415.1991.tb01616.x.
    1. Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990;45(6):M197. doi: 10.1093/geronj/45.6.M192.
    1. Badia X, Roset M, Montserrat S, Herdman M, Segura A. The spanish version of EuroQol: a description and its applications. European quality of life scale. Med Clin. 1998;112:79–85.
    1. Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001;8(12):1153–1157. doi: 10.1111/j.1553-2712.2001.tb01132.x.
    1. Cox DR, Oakes D. Analysis of survival data. Vol 21. Chapman & Hall: CRC Press; 1984. ISBN 0412224909, 9780412224904.
    1. Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. New South Wales public health bulletin. 2011;22(4):78–83. doi: 10.1071/NB10056.
    1. Friedman LM, Furberg C, DeMets DL, Reboussin DM, Granger CB. Fundamentals of clinical trials. Vol 3. New York: Springer; 1998. ISBN 978-1-4419-1586-3.
    1. Detsky AS, Naglie IGA. clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990;113(2):147–154. doi: 10.7326/0003-4819-113-2-147.
    1. Localio AR, Berlin JA, Ten Have TR, Kimmel SE. Adjustments for center in multicenter studies: an overview. Ann Intern Med. 2001;135(2):112–123. doi: 10.7326/0003-4819-135-2-200107170-00012.
    1. Vierron E, Giraudeau B. Sample size calculation for multicenter randomized trial: taking the center effect into account. Contemporary clinical trials. 2007;28(4):451–458. doi: 10.1016/j.cct.2006.11.003.

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