Skip to main content
Top
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial

Authors: Sarah Eichler, Sophie Rabe, Annett Salzwedel, Steffen Müller, Josefine Stoll, Nina Tilgner, Michael John, Karl Wegscheider, Frank Mayer, Heinz Völler, on behalf of the ReMove-It study group

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain.

Methods/design

This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index, the International Physical Activity Questionnaire, and postural control as well as gait and kinematic parameters of the lower limbs. Baseline-adjusted analysis of covariance models will be used to test for group differences in the primary and secondary endpoints.

Discussion

We expect the intervention group to benefit from the interactive, home-based exercise training in many respects represented by the study endpoints. If successful, this approach could be used to enhance the access to aftercare programs, especially in structurally weak areas.

Trial registration

German Clinical Trials Register (DRKS), ID: DRKS00010009. Registered on 11 May 2016.
Appendix
Available only for authorised users
Literature
1.
go back to reference Wengler A, Nimptsch U, Mansky T. Hip and knee replacement in Germany and the USA: analysis of individual inpatient data from German and US hospitals for the years 2005 to 2011. Dtsch Arztebl Int. 2014;111:407–16.PubMedPubMedCentral Wengler A, Nimptsch U, Mansky T. Hip and knee replacement in Germany and the USA: analysis of individual inpatient data from German and US hospitals for the years 2005 to 2011. Dtsch Arztebl Int. 2014;111:407–16.PubMedPubMedCentral
2.
go back to reference OECD. Hip and knee replacement. In: Health at a glance 2015: OECD indicators. Paris: OECD Publishing; 2015.CrossRef OECD. Hip and knee replacement. In: Health at a glance 2015: OECD indicators. Paris: OECD Publishing; 2015.CrossRef
3.
go back to reference Muller M, Toussaint R, Kohlmann T. Total hip and knee arthroplasty: results of outpatient orthopedic rehabilitation. Orthopade. 2015;44:203–11.CrossRefPubMed Muller M, Toussaint R, Kohlmann T. Total hip and knee arthroplasty: results of outpatient orthopedic rehabilitation. Orthopade. 2015;44:203–11.CrossRefPubMed
5.
go back to reference Aliyev RM. Total hip replacement using the Staffelstein score: outcome of inpatient rehabilitation. Orthopade. 2010;39:1163–70.CrossRefPubMed Aliyev RM. Total hip replacement using the Staffelstein score: outcome of inpatient rehabilitation. Orthopade. 2010;39:1163–70.CrossRefPubMed
6.
go back to reference Baulig C, Grams M, Rohrig B, Linck-Eleftheriadis S, Krummenauer F. Clinical outcome and cost effectiveness of inpatient rehabilitation after total hip and knee arthroplasty. A multi-centre cohort benchmarking study between nine rehabilitation departments in Rhineland-Palatinate (Western Germany). Eur J Phys Rehabil Med. 2015;51:803–13.PubMed Baulig C, Grams M, Rohrig B, Linck-Eleftheriadis S, Krummenauer F. Clinical outcome and cost effectiveness of inpatient rehabilitation after total hip and knee arthroplasty. A multi-centre cohort benchmarking study between nine rehabilitation departments in Rhineland-Palatinate (Western Germany). Eur J Phys Rehabil Med. 2015;51:803–13.PubMed
7.
go back to reference Müller E, Mittag O, Gülich M, Uhlmann A, Jäckel WH. Systematic literature analysis on therapies applied in rehabilitation of hip and knee arthroplasty: methods, results and challenges. Rehabilitation. 2009;48:62–72.CrossRefPubMed Müller E, Mittag O, Gülich M, Uhlmann A, Jäckel WH. Systematic literature analysis on therapies applied in rehabilitation of hip and knee arthroplasty: methods, results and challenges. Rehabilitation. 2009;48:62–72.CrossRefPubMed
8.
go back to reference Tuncel T, Simon S, Peters KM. Flexible rehabilitation times after total hip and knee replacement. Orthopade. 2015;44:465–73.CrossRefPubMed Tuncel T, Simon S, Peters KM. Flexible rehabilitation times after total hip and knee replacement. Orthopade. 2015;44:465–73.CrossRefPubMed
9.
go back to reference Khan F, Ng L, Gonzalez S, Hale T, Turner-Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database Syst Rev. 2008;16:CD004957. Khan F, Ng L, Gonzalez S, Hale T, Turner-Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database Syst Rev. 2008;16:CD004957.
10.
go back to reference Bleß H-H, Kip M. Weißbuch Gelenkersatz. Versorgungssituation endo prothetischer Hüft- und Knieoperationen in Deutschland. Berlin Heidelberg: Springer-Verlag; 2017. Bleß H-H, Kip M. Weißbuch Gelenkersatz. Versorgungssituation endo prothetischer Hüft- und Knieoperationen in Deutschland. Berlin Heidelberg: Springer-Verlag; 2017.
11.
go back to reference Westby MD, Brittain A, Backman CL. Expert consensus on best practices for post-acute rehabilitation after total hip and knee arthroplasty: a Canada and United States Delphi study. Arthritis Care Res (Hoboken). 2014;66:411–23.CrossRef Westby MD, Brittain A, Backman CL. Expert consensus on best practices for post-acute rehabilitation after total hip and knee arthroplasty: a Canada and United States Delphi study. Arthritis Care Res (Hoboken). 2014;66:411–23.CrossRef
12.
go back to reference Sibold M, Mittag O, Kulick B, Müller E, Opitz U, Jäckel WH. Predictors of participation in medical rehabilitation follow-up in working patients with chronic back pain. Rehabilitation. 2011;50:363–71.CrossRefPubMed Sibold M, Mittag O, Kulick B, Müller E, Opitz U, Jäckel WH. Predictors of participation in medical rehabilitation follow-up in working patients with chronic back pain. Rehabilitation. 2011;50:363–71.CrossRefPubMed
13.
go back to reference Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: a randomized control study. J Telemed Telecare. 2017;23:239–47.CrossRefPubMed Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: a randomized control study. J Telemed Telecare. 2017;23:239–47.CrossRefPubMed
14.
go back to reference Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-home telerehabilitation compared with face-to-face rehabilitation after total knee arthroplasty: a noninferiority randomized controlled trial. J Bone Joint Surg Am. 2015;97:1129–41.CrossRefPubMed Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-home telerehabilitation compared with face-to-face rehabilitation after total knee arthroplasty: a noninferiority randomized controlled trial. J Bone Joint Surg Am. 2015;97:1129–41.CrossRefPubMed
15.
go back to reference Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthroplasty: a randomized controlled trial. J Rehabil Med. 2013;45:392–6.CrossRefPubMed Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthroplasty: a randomized controlled trial. J Rehabil Med. 2013;45:392–6.CrossRefPubMed
16.
go back to reference Tousignant M, Moffet H, Boissy P, Corriveau H, Cabana F, Marquis F. A randomized controlled trial of home telerehabilitation for post-knee arthroplasty. J Telemed Telecare. 2011;17:195–8.CrossRefPubMed Tousignant M, Moffet H, Boissy P, Corriveau H, Cabana F, Marquis F. A randomized controlled trial of home telerehabilitation for post-knee arthroplasty. J Telemed Telecare. 2011;17:195–8.CrossRefPubMed
17.
go back to reference Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of benefit of telerehabitation after orthopedic surgery: a systematic review. J Med Internet Res. 2017;19:e142.CrossRefPubMedPubMedCentral Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of benefit of telerehabitation after orthopedic surgery: a systematic review. J Med Internet Res. 2017;19:e142.CrossRefPubMedPubMedCentral
18.
go back to reference Eisermann U, Haase I, Kladny B. Computer-aided multimedia training in orthopedic rehabilitation. Am J Phys Med Rehabil. 2004;83:670–80.CrossRefPubMed Eisermann U, Haase I, Kladny B. Computer-aided multimedia training in orthopedic rehabilitation. Am J Phys Med Rehabil. 2004;83:670–80.CrossRefPubMed
19.
go back to reference Anton D, Nelson M, Russell T, Goni A, Illarramendi A. Validation of a Kinect-based telerehabilitation system with total hip replacement patients. J Telemed Telecare. 2016;22:192–7.CrossRefPubMed Anton D, Nelson M, Russell T, Goni A, Illarramendi A. Validation of a Kinect-based telerehabilitation system with total hip replacement patients. J Telemed Telecare. 2016;22:192–7.CrossRefPubMed
20.
go back to reference ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166:111–7.CrossRef ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166:111–7.CrossRef
21.
go back to reference Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–8.CrossRefPubMed Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–8.CrossRefPubMed
22.
go back to reference Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater reliability and validity of the stair ascend/descend test in subjects with total knee arthroplasty. Arch Phys Med Rehabil. 2010;91:932–8.CrossRefPubMedPubMedCentral Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater reliability and validity of the stair ascend/descend test in subjects with total knee arthroplasty. Arch Phys Med Rehabil. 2010;91:932–8.CrossRefPubMedPubMedCentral
23.
go back to reference Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005;85:1034–45.PubMed Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005;85:1034–45.PubMed
24.
go back to reference Gandek B, Ware Jr JE, Aaronson NK, Alonso J, Apolone G, Bjorner J, Brazier J, Bullinger M, Fukuhara S, Kaasa S, et al. Tests of data quality, scaling assumptions, and reliability of the SF-36 in eleven countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:1149–58.CrossRefPubMed Gandek B, Ware Jr JE, Aaronson NK, Alonso J, Apolone G, Bjorner J, Brazier J, Bullinger M, Fukuhara S, Kaasa S, et al. Tests of data quality, scaling assumptions, and reliability of the SF-36 in eleven countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:1149–58.CrossRefPubMed
25.
go back to reference Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95.CrossRefPubMed Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95.CrossRefPubMed
26.
go back to reference Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed
27.
go back to reference Mueller S, Mueller J, Stoll J, Cassel M, Hirschmüller A, Mayer F. Back pain in adolescent athletes: results of a biomechanical screening. Sports Med Int Open. 2017;01:E16–22.CrossRef Mueller S, Mueller J, Stoll J, Cassel M, Hirschmüller A, Mayer F. Back pain in adolescent athletes: results of a biomechanical screening. Sports Med Int Open. 2017;01:E16–22.CrossRef
28.
go back to reference Eichelberger P, Ferraro M, Minder U, Denton T, Blasimann A, Krause F, Baur H. Analysis of accuracy in optical motion capture—A protocol for laboratory setup evaluation. J Biomech. 2016;49:2085–8.CrossRefPubMed Eichelberger P, Ferraro M, Minder U, Denton T, Blasimann A, Krause F, Baur H. Analysis of accuracy in optical motion capture—A protocol for laboratory setup evaluation. J Biomech. 2016;49:2085–8.CrossRefPubMed
29.
go back to reference Parent E, Moffet H. Comparative responsiveness of locomotor tests and questionnaires used to follow early recovery after total knee arthroplasty. Arch Phys Med Rehabil. 2002;83:70–80.CrossRefPubMed Parent E, Moffet H. Comparative responsiveness of locomotor tests and questionnaires used to follow early recovery after total knee arthroplasty. Arch Phys Med Rehabil. 2002;83:70–80.CrossRefPubMed
30.
go back to reference Boardman DL, Dorey F, Thomas BJ, Lieberman JR. The accuracy of assessing total hip arthroplasty outcomes: a prospective correlation study of walking ability and 2 validated measurement devices. J Arthroplasty. 2000;15:200–4.CrossRefPubMed Boardman DL, Dorey F, Thomas BJ, Lieberman JR. The accuracy of assessing total hip arthroplasty outcomes: a prospective correlation study of walking ability and 2 validated measurement devices. J Arthroplasty. 2000;15:200–4.CrossRefPubMed
31.
go back to reference Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013;14:145.CrossRefPubMedPubMedCentral Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013;14:145.CrossRefPubMedPubMedCentral
32.
go back to reference Unver B, Kahraman T, Kalkan S, Yuksel E, Karatosun V. Reliability of the six-minute walk test after total hip arthroplasty. Hip Int. 2013;23:541–5.CrossRefPubMed Unver B, Kahraman T, Kalkan S, Yuksel E, Karatosun V. Reliability of the six-minute walk test after total hip arthroplasty. Hip Int. 2013;23:541–5.CrossRefPubMed
33.
go back to reference Rohrig B, du Prel JB, Wachtlin D, Kwiecien R, Blettner M. Sample size calculation in clinical trials: part 13 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2010;107:552–6.PubMedPubMedCentral Rohrig B, du Prel JB, Wachtlin D, Kwiecien R, Blettner M. Sample size calculation in clinical trials: part 13 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2010;107:552–6.PubMedPubMedCentral
34.
go back to reference Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015;21:202–13.CrossRefPubMed Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015;21:202–13.CrossRefPubMed
35.
go back to reference Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don’t patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001;55:132–8.CrossRefPubMedPubMedCentral Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don’t patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001;55:132–8.CrossRefPubMedPubMedCentral
36.
go back to reference Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical therapy. Phys Ther. 1993;73:771–82. discussion 783–776.CrossRefPubMed Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical therapy. Phys Ther. 1993;73:771–82. discussion 783–776.CrossRefPubMed
37.
go back to reference O'Brien N, McDonald S, Araujo-Soares V, Lara J, Errington L, Godfrey A, Meyer TD, Rochester L, Mathers JC, White M, Sniehotta FF. The features of interventions associated with long-term effectiveness of physical activity interventions in adults aged 55–70 years: a systematic review and meta-analysis. Health Psychol Rev. 2015;9:417–33.CrossRefPubMed O'Brien N, McDonald S, Araujo-Soares V, Lara J, Errington L, Godfrey A, Meyer TD, Rochester L, Mathers JC, White M, Sniehotta FF. The features of interventions associated with long-term effectiveness of physical activity interventions in adults aged 55–70 years: a systematic review and meta-analysis. Health Psychol Rev. 2015;9:417–33.CrossRefPubMed
Metadata
Title
Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial
Authors
Sarah Eichler
Sophie Rabe
Annett Salzwedel
Steffen Müller
Josefine Stoll
Nina Tilgner
Michael John
Karl Wegscheider
Frank Mayer
Heinz Völler
on behalf of the ReMove-It study group
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2173-3

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue