Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial

Michel Tousignant, Hélène Corriveau, Dahlia Kairy, Katherine Berg, Marie-France Dubois, Sylvie Gosselin, Richard H Swartz, Jean-Martin Boulanger, Cynthia Danells, Michel Tousignant, Hélène Corriveau, Dahlia Kairy, Katherine Berg, Marie-France Dubois, Sylvie Gosselin, Richard H Swartz, Jean-Martin Boulanger, Cynthia Danells

Abstract

Background: The incidence of strokes in industrialized nations is on the rise, particularly in the older population. In Canada, a minority of individuals who have had a stroke actually receive intensive rehabilitation because most stroke patients do not have access to services or because their motor recovery was judged adequate to return home. Thus, there is a considerable need to organize home-based rehabilitation services for everyone who has had a stroke. To meet this demand, telerehabilitation, particularly from a service center to the patient's home, is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home.

Methods/design: This non-inferiority study will include patients who have returned home post-stroke without requiring intensive rehabilitation. To be included in the study, participants will: 1) not be referred to an Intensive Functional Rehabilitation Unit, 2) have a Rankin score of 2 or 3, and 3) have a balance problem (Berg Balance Scale score between 46 and 54). Participants will be randomly assigned to either the teletreatment group or the home visits group. Except for the delivery mode, the intervention will be the same for both groups, that is, a personalized Tai Chi-based exercise program conducted by a trained physiotherapist (45-minute session twice a week for eight consecutive weeks). The main objective of this research is to test the non-inferiority of a Tai Chi-based exercise program provided via telerehabilitation compared to the same program provided in person at home in terms of effectiveness for retraining balance in individuals who have had a stroke but do not require intensive functional rehabilitation. The main outcome of this study is balance and mobility measured with the Community Balance and Mobility Scale. Secondary outcomes include physical and psychological capacities related to balance and mobility, participants' quality of life, satisfaction with services received, and cost-effectiveness associated with the provision of both types of services.

Study/trial registration: ClinicalTrials.gov: NCT01848080.

Figures

Figure 1
Figure 1
Research design and timeline.

References

    1. Sacco RL, Benjamin EL, Broderick JP, Dyken M, Eston JD, Feinberg WM, Goldstein LB, Gorelick PB, Howard G, Kittner SJ, Manolio TA, Whisnant JP, Wolf PA. American Heart Association Prevention Conference. IV. Prevention and Rehabilitation of Stroke. Risk factors. Stroke. 1997;28(7):1507. doi: 10.1161/01.STR.28.7.1507.
    1. Dimyan MA, Cohen LG. Neuroplasticity in the context of motor rehabilitation after stroke. Nat Rev Neurol. 2011;7(2):76. doi: 10.1038/nrneurol.2010.200.
    1. Forster A, Young J. Stroke rehabilitation: can we do better? BMJ. 1992;305(6867):1446. doi: 10.1136/bmj.305.6867.1446.
    1. Wada N, Sohmiya M, Shimizu T, Okamoto K, Shirakura K. Clinical analysis of risk factors for falls in home-living stroke patients using functional evaluation tools. Arch Phys Med Rehabil. 2007;88(12):1601. doi: 10.1016/j.apmr.2007.09.005.
    1. Stolze H, Klebe S, Zechlin C, Baecker C, Friege L, Deuschl G. Falls in frequent neurological diseases - prevalence, risk factors and etiology. J Neurol. 2004;251(1):79. doi: 10.1007/s00415-004-0276-8.
    1. Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM. Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003;34(2):494. doi: 10.1161/01.STR.0000053444.00582.B7.
    1. Simpson LA, Miller WC, Eng JJ. Effect of stroke on fall rate, location and predictors: a prospective comparison of older adults with and without stroke. PloS One. 2011;6(4):e19431. doi: 10.1371/journal.pone.0019431.
    1. Tinetti ME, Baker DI, Dutcher J, Vincent JE, Rozett RT. Reducing the risk of falls among older adults in the community. Berkeley, CA: Peaceable Kingdom Press; 1997.
    1. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012;9 CD007146.
    1. Lincoln NB, Gladman JR, Berman P, Luther A, Challen K. Rehabilitation needs of community stroke patients. Disabil Rehabil. 1998;20(12):457–463. doi: 10.3109/09638289809166110.
    1. Canadian Stroke Network. La qualité des soins de l'AVC au Canada. .
    1. Bates B, Choi JY, Duncan PW, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D, Zorowitz R. US Department of Defense; Department of Veterans Affairs. Veterans Affairs/Department of Defense Clinical Practice Guideline for the Management of Adult Stroke Rehabilitation Care: executive summary. Stroke. 2005;36(9):2049. doi: 10.1161/.
    1. Edwards DF, Hahn MG, Baum CM, Perlmutter MS, Sheedy C, Dromerick AW. Screening patients with stroke for rehabilitation needs: validation of the post-stroke rehabilitation guidelines. Neurorehabil Neural Repair. 2006;20(1):42. doi: 10.1177/1545968305283038.
    1. Mayo NE, Wood-Dauphinee S, Côté R, Durcan L, Carlton J. Activity, participation, and quality of life six months poststroke. Arch Phys Med Rehabil. 2002;83(8):1035. doi: 10.1053/apmr.2002.33984.
    1. Chuang KY, Wu SC, Ma AH, Chen YH, Wu CL. Identifying factors associated with hospital readmissions among stroke patients in Taipei. J Nurs Res. 2005;13(2):117. doi: 10.1097/01.JNR.0000387533.07395.42.
    1. Thorsen AM, Holmqvist LW, de Pedro-Cuesta J, von Koch L. A randomized controlled trial of early supported discharge and continued rehabilitation at home after stroke: five-year follow-up of patient outcome. Stroke. 2005;36(2):297. doi: 10.1161/01.STR.0000152288.42701.a6.
    1. Lindsay P, Bayley M, Hellings C, Hill M, Woodbury E, Philips S. Recommandations canadiennes pour les pratiques optimales de soins de l'AVC (mise à jour de 2008) - Sommaire. CMAJ. 2008;179(12):SF1. doi: 10.1503/cmaj.081148.R2.
    1. Ministère de la santé et des services sociaux du Québec. Chez soi: le premier choix. La politique de soutien à domicile. .
    1. Ministère de la santé et des services sociaux du Québec. Chez soi: le premier choix. Précisions pour favoriser l'implantation de la politique de soutien à domicile. .
    1. Hogenbirk JC, Brockway PD, Finley J, Jennett P, Yeo M, Parker-Taillon D, Pong RW, Szpilfogel CC, Reid D, MacDonald-Rencz S, Cradduck T. Framework for Canadian telehealth guidelines: summary of the environmental scan. J Telemed Telecare. 2006;12(2):64. doi: 10.1258/135763306776084338.
    1. Pineau G, Moqadem K, St-Hilaire C, Levac E, Hamel BT. Lignes directrices cliniques et normes technologiques en téléréadpatation, in Agences des technologies et des modes d'intervention en santé. .
    1. Brennan D, Mawson S, Brownsell S. Telerehabilitation: enabling the remote delivery of healthcare, rehabilitation, and self management. Stud Health Technol Inform. 2009;145:231.
    1. McCue M, Fairman A, Pramuka M. Enhancing quality of life through telerehabilitation. Phys Med Rehabil Clin N Am. 2010;21(1):195. doi: 10.1016/j.pmr.2009.07.005.
    1. Theodoros D, Russell T. Telerehabilitation: current perspectives. Stud Health Technol Inform. 2008;131:191.
    1. Romanow RJ. L'Avenir des soins de santé au Canada. .
    1. Wong AM, Yu-Cheng P, Ching L, Shu-Chun H, Yin-Chou L, Shih-Wei C. Is Tai Chi Chuan effective in improving lower limb response time to prevent backward falls in the elderly? Age (Dordr) 2009;31(2):163. doi: 10.1007/s11357-009-9094-3.
    1. Sattin RW, Sley KA, Wolf SL, Chen Y, Kutner MH. Reduction in fear of falling through intense Tai Chi exercise training in older, transitionally frail adults. J Am Geriatr Soc. 2005;53:1168. doi: 10.1111/j.1532-5415.2005.53375.x.
    1. Corriveau H, Sveistrup H, Tousignant M. Effects of Tai Chi Exercise on Clinical Measures of Balance and Attention Demand in Older Individuals with Moderate Diabetic Peripheral Neuropathy. Burlingon (USA): Proceedings of Symposium International of gait and posture: 3 to 5 July 2007; 2007.
    1. Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hébert R. Efficacy of supervised Tai Chi exercises versus conventional physical therapy exercises in fall prevention for frail older adults: a randomized controlled trial. Disabil Rehabil. 2012;35(17):1429.
    1. Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hébert R, Tremblay-Boudreault V, Beaudoin AJ. The effect of supervised Tai Chi intervention compared to a physiotherapy program on fall-related clinical outcomes: a randomized clinical trial. Disabil Rehabil. 2012;34(3):196. doi: 10.3109/09638288.2011.591891.
    1. Au-Yeung S, Hui-Chan CW, Tang JC. Short-form Tai Chi improves standing balance of people with chronic stroke. Neurorehabil Neural Repair. 2009;23(5):515–522. doi: 10.1177/1545968308326425.
    1. Har J, Kanner H, Gilboa-Mayo R, Haroeh-Peer O, Rozenthul-Sorokin N, Eldar R. Tai Chi Chuan practice in community-dwelling persons after stroke. Int J Rehabil Res. 2004;27(4):303. doi: 10.1097/00004356-200412000-00008.
    1. Wu G, Keyes LM. Group tele-exercise for improving balance in elders. Telemed J E Health. 2006;12:561–570. doi: 10.1089/tmj.2006.12.561.
    1. Wooton A. An integrative review of Tai Chi research: an alternative form of physical activity to improve balance and prevent falls in older adults. Orthop Nurs. 2010;29(2):108. doi: 10.1097/NOR.0b013e3181d243b3.
    1. Bashshur R, Shannon G, Krupinski E, Grigsby J. The taxonomy of telemedicine. Telemed J E Health. 2011;17(6):484. doi: 10.1089/tmj.2011.0103.
    1. Tousignant M, Boissy P, Moffet H, Corriveau H, Cabana F, Marquis F, Simard J. Patients' satisfaction of healthcare services and perception with in-home telerehabilitation and physiotherapists' satisfaction toward technology for post-knee arthroplasty: an embedded study in a randomized trial. Telemed J E Health. 2011;17(5):376. doi: 10.1089/tmj.2010.0198.
    1. Dechêne L, Tousignant M, Boissy P, Macoir J, Héroux S, Hamel M, Brière S, Pagé C. Simulated in-home teletreatment for anomia. Int J Telerehabil. 2011;3(2):3.
    1. Tousignant M, Marquis N, Pagé C, Imukuze N, Métivier A, St-Onge V, Tremblay A. In-home telerehabilitation for older persons with chronic obstructive pulmonary disease: a pilot Study. Int J Telerehabil. 2012;4(1):7.
    1. Lai SM, Duncan PW. Stroke recovery profile and the Modified Rankin assessment. Neuroepidemiology. 2001;20(1):26. doi: 10.1159/000054754.
    1. Berg K, Wood-Dauphinee S, Williams J. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995;27(1):27.
    1. Wolf SL, Coogler C, Xu T. Exploring the basis for Tai Chi Chuan as a therapeutic exercise approach. Arch Phys Med Rehabil. 1997;78(8):886. doi: 10.1016/S0003-9993(97)90206-9.
    1. Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010;34(3):127. doi: 10.1097/NPT.0b013e3181ef764d.
    1. Howe JA, Inness EL, Venturini A, Williams JI, Verrier MC. The Community Balance and Mobility Scale - a balance measure for individuals with traumatic brain injury. Clin Rehabil. 2006;20(10):885.
    1. Knorr S, Brouwer B, Garland SJ. Validity of the Community Balance and Mobility Scale in community-dwelling persons after stroke. Arch Phys Med Rehabil. 2010;91(6):890. doi: 10.1016/j.apmr.2010.02.010.
    1. Salbach NM, Mayo NE, Higgins J, Ahmed S, Finch LE, Richards CL. Responsiveness and predictability of gait speed and other disability measures in acute stroke. Arch Phys Med Rehabil. 2001;82(9):1204. doi: 10.1053/apmr.2001.24907.
    1. Rocque R, Bartlett D, Brown J, Garland SJ. Influence of age and gender of healthy adults on scoring patterns on the Community Balance and Mobility Scale. Physiother Can. 2005;57:285. doi: 10.3138/ptc.57.4.285.
    1. Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993;24(1):58. doi: 10.1161/01.STR.24.1.58.
    1. Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Physical therapy. 2008;88(5):559. doi: 10.2522/ptj.20070205.
    1. Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002;83(11):1566. doi: 10.1053/apmr.2002.35469.
    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.
    1. Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC. Psychometric comparisons of the timed up and go, one-leg stand, functional reach, and Tinetti balance measures in community-dwelling older people. J Am Geriatr Soc. 2004;52(8):1343. doi: 10.1111/j.1532-5415.2004.52366.x.
    1. Wade DT, Wood VA, Heller A, Maggs J, Langton Hewer R. Walking after stroke. Measurement and recovery over the first three months. Scand J Rehabil Med. 1987;19(1):25.
    1. Dean CM, Richards CL, Malouin F. Walking speed over 10 meters overestimates locomotor capacity after stroke. Clin Rehabil. 2001;15(4):415. doi: 10.1191/026921501678310216.
    1. Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992;5(5):682.
    1. Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995;80(1):163. doi: 10.2466/pms.1995.80.1.163.
    1. Csuka M, McCarty DJ. Simple method for measurement of lower extremity muscle strength. Am J Med. 1985;78(1):77.
    1. Lord SR, Murray SM, Chapman K, Munro B, Tiedemann A. Sit-to-stand performance depends on sensation, speed, balance, and psychological status in addition to strength in older people. J Gerontol A Biol Sci Med Sci. 2002;57(8):M539. doi: 10.1093/gerona/57.8.M539.
    1. Newcomer KL, Krug HE, Mahowald ML. Validity and reliability of the timed-stands test for patients with rheumatoid arthritis and other chronic diseases. J Rheumatol. 1993;20(1):21.
    1. Valach L, Signer S, Hartmeier A, Hofer K, Steck GC. Chedoke-McMaster stroke assessment and modified Barthel Index self-assessment in patients with vascular brain damage. Int J Rehabil Res. 2003;26(2):93. doi: 10.1097/00004356-200306000-00003.
    1. Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S, Corriveau H, Richard L. Evidence of the psychometric qualities of a simplified version of the Activities-specific Balance Confidence scale for community-dwelling seniors. Arch Phys Med Rehabil. 2007;88(5):664. doi: 10.1016/j.apmr.2007.02.003.
    1. Jorstad EC, Hauer K, Becker C, Lamb SE. ProFaNE Group. Measuring the psychological outcomes of falling: a systematic review. J Am Geriatr Soc. 2005;53(3):501. doi: 10.1111/j.1532-5415.2005.53172.x.
    1. Scholz U, Gutiérrez-Doña B, Sud S, Schwarzer R. Is general self-efficacy a universal construct? Psychometric findings from 25 countries. Eur J Psychol Ass. 2002;18(3):242. doi: 10.1027//1015-5759.18.3.242.
    1. Wood-Dauphinee SL, Opzoomer MA, Williams JI, Marchand B, Spitzer WO. Assessment of global function: the Reintegration to Normal Living Index. Arch Phys Med Rehabil. 1988;69(8):583.
    1. Daneski K, Coshall C, Tilling K, Wolfe CD. Reliability and validity of a postal version of the Reintegration to Normal Living Index, modified for use with stroke patients. Clin Rehabil. 2003;17(8):835. doi: 10.1191/0269215503cr686oa.
    1. Gagnon M, Hebert R, Dubé M, Dubois MF. Development and validation of an instrument measuring individual empowerment in relation to personal health care: the Health Care Empowerment Questionnaire (HCEQ) Am J Health Promot. 2006;20(6):429. doi: 10.4278/0890-1171-20.6.429.
    1. Chapko MK, Hedrick S. Cost as a study outcome: sensitivity of study conclusions to the method of estimating cost. Med Care. 1999;37(4 Suppl Va):AS37.
    1. Tousignant M, Moffet H, Boissy B, Cooriveau H, Cabana F, Marquis F. A randomized controlled trial of home telerehabilitation for post-knee arthroplasty. J Telemed Telecare. 2011;17(4):195. doi: 10.1258/jtt.2010.100602.
    1. Groll DL, To T, Bombardier C, Wright JG. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol. 2005;58(6):595. doi: 10.1016/j.jclinepi.2004.10.018.
    1. Brott T, Adams JR, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–870. doi: 10.1161/01.STR.20.7.864.
    1. Lyden P, Brott T, Tilley B, Welch KM, Mascha EJ, Levine S, Haley EC, Grotta J, Marler J. Improved reliability of the NIH Stroke Scale using video training. NINDS TPA Stroke Study Group. Stroke. 1994;25(11):2220. doi: 10.1161/01.STR.25.11.2220.
    1. Goldstein LB, Bertels C, Davis JN. Interrater reliability of the NIH stroke scale. Arch Neurol. 1989;46(6):660. doi: 10.1001/archneur.1989.00520420080026.
    1. Pendlebury ST, Cuthbertson FC, Welch SJ, Mehta Z, Rothwell PM. Underestimation of cognitive impairment by Mini-Mental State Examination versus the Montreal Cognitive Assessment in patients with transient ischemic attack and stroke: a population-based study. Stroke. 2010;41(6):1290. doi: 10.1161/STROKEAHA.110.579888.
    1. Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695. doi: 10.1111/j.1532-5415.2005.53221.x.
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308:2594. doi: 10.1001/jama.2012.87802.
    1. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313(7048):36. doi: 10.1136/bmj.313.7048.36.
    1. Drummond MF, O'Brien B, Stoddart GL, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes. 2. Oxford: Oxford University Press; 1997.
    1. Harteloh PP. The meaning of quality in health care: a conceptual analysis. Health Care Anal. 2003;11(3):259.
    1. Campbell SM, Roland MO, Buetow SA. Defining quality of care. Soc Sci Med. 2000;51(11):1611. doi: 10.1016/S0277-9536(00)00057-5.
    1. Fleishman R. Non-medical predictors of quality of care of hypertension in elderly patients. Int J Health Care Qual Assur Inc Leadersh Health Serv. 1997;10(2–3):107.
    1. Larson JS, Muller A. Managing the quality of health care. J Health Hum Serv Adm. 2002;25(3):261.
    1. Zonsius MK, Murphy M. Use of total quality management sparks staff nurse participation in continuous quality improvement. Nurs Clin North Am. 1995;30(1):1.
    1. Duffy JR, Hoskins LM. The quality-caring model: blending dual paradigms. ANS Adv Nurs Sci. 2003;26(1):77. doi: 10.1097/00012272-200301000-00010.
    1. Kennedy K, Mirmirani S, Spivack R. Continuous quality improvement in health maintenance organizations: an application of the HEDIS model. Int J Health Care Qual Assur. 1996;9(4):4. doi: 10.1108/09526869610124164.
    1. Tasso K, Behar-Horenstein LS, Aumiller A, Gamble K, Grimaudo N, Guin P, Mandell T, Ramey B. Assessing patient satisfaction and quality of care through observation and interview. Hospital Topic. 2002;80(3):4. doi: 10.1080/00185860209597996.

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