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BMC Neurology
Published in: BMC Neurology 1/2017

Open Access 01-12-2017 | Study protocol

Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis

Authors: Lynne V. Gauthier, Chelsea Kane, Alexandra Borstad, Nancy Strahl, Gitendra Uswatte, Edward Taub, David Morris, Alli Hall, Melissa Arakelian, Victor Mark

Published in: BMC Neurology | Issue 1/2017

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Abstract

Background

Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined.

Methods

This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL).

Discussion

This multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation.

Trial registration

Clinicaltrials.gov, NCT02631850.
Literature
1.
Gladstone DJ, Black SE, Hakim AM. Heart and Stroke Foundation of Ontario Centre of Excellence in stroke recovery. Toward wisdom from failure: lessons from neuroprotective stroke trials and new therapeutic directions. Stroke. 2002;33(8):2123–36.CrossRefPubMed
2.
Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, et al. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005;36(9):e100–43.CrossRefPubMed
3.
Dhamoon MS, Moon YP, Paik MC, Boden-Albala B, Rundek T, Sacco RL, et al. Long-term functional recovery after first ischemic stroke: the northern Manhattan study. Stroke. 2009;40(8):2805–11.CrossRefPubMedPubMedCentral
4.
Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, et al. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009;90(10):1692–8.CrossRefPubMedPubMedCentral
5.
Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, et al. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006;296(17):2095–104.CrossRefPubMed
6.
Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010;24(7):620–35.CrossRefPubMedPubMedCentral
7.
Lang C, Lohsec K, Birkenmeiera R. Dose and timing in neurorehabilitation: prescribing motor therapy after stroke. Curr Opin Neurol. 2015;28(6):549–55.CrossRefPubMedPubMedCentral
8.
Schaefer SY, Patterson CB, Lang CE. Transfer of training between distinct motor tasks after stroke: implications for task-specific approaches to upper-extremity neurorehabilitation. Neurorehabil Neural Repair. 2013;27(7):602–12.CrossRefPubMedPubMedCentral
9.
Shepherd RB. Exercise and training to optimize functional motor performance in stroke: driving neural reorganization? Neural Plast. 2001;8(1–2):121–9.CrossRefPubMedPubMedCentral
10.
Teasell R, Foley N, Salter K, Bhogal S, Jutai J, Speechley M. Evidence-based review of stroke rehabilitation: executive summary, 12th edition. Top Stroke Rehabil. 2009;16(6):463–88.CrossRefPubMed
11.
12.
Takebayashi T, Koyama T, Amano S, Hanada K, Tabusadani M, Hosomi M, et al. A 6-month follow-up after constraint-induced movement therapy with and without transfer package for patients with hemiparesis after stroke: a pilot quasi-randomized controlled trial. Clin Rehabil. 2012;27(5):418–26.CrossRefPubMed
13.
Taub E, Uswatte G, Mark VW, Morris DM, Barman J, Bowman MH, et al. Method for enhancing real-world use of a more affected arm in chronic stroke: transfer package of constraint-induced movement therapy. Stroke. 2013;44(5):1383–8.CrossRefPubMedPubMedCentral
14.
Gauthier LV, Taub E, Perkins C, Ortmann M, Mark VW, Uswatte G. Remodeling the brain: plastic structural brain changes produced by different motor therapies after stroke. Stroke. 2008;39(5):1520–5.CrossRefPubMedPubMedCentral
15.
Sterling C, Taub E, Davis D, Rickards T, Gauthier LV, Griffin A, et al. Structural neuroplastic change after constraint-induced movement therapy in children with cerebral palsy. Pediatrics. 2013;131(5):e1664–9.CrossRefPubMed
16.
Barzel A, Ketels G, Stark A, Tetzlaff B, Daubmann A, Wegscheider K, et al. Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial. Lancet Neurol. 2015;14(9):893–902.CrossRefPubMed
17.
Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006;42(3):241–56.PubMed
18.
Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006;42(3):257–68.PubMed
19.
Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006;37(4):1045–9.CrossRefPubMed
20.
McIntyre A, Viana R, Janzen S, Mehta S, Pereira S, Teasell R. Systematic review and meta-analysis of constraint-induced movement therapy in the hemiparetic upper extremity more than six months post stroke. Top Stroke Rehabil. 2012;19(6):499–513.CrossRefPubMed
21.
Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011;92(6):972–82.CrossRefPubMed
22.
Lin KC, Chang YF, Wu CY, Chen YA. Effects of constraint-induced therapy versus bilateral arm training on motor performance, daily functions, and quality of life in stroke survivors. Neurorehabil Neural Repair. 2009;23(5):441–8.CrossRefPubMed
23.
Wu CY, Chuang LL, Lin KC, Chen HC, Tsay PK. Randomized trial of distributed constraint-induced therapy versus bilateral arm training for the rehabilitation of upper-limb motor control and function after stroke. Neurorehabil Neural Repair. 2011;25(2):130–9.CrossRefPubMed
24.
Stevenson T, Thalman L, Christie H, Poluha W. Constraint-induced movement therapy compared to dose-matched interventions for upper-limb dysfunction in adult survivors of stroke: a systematic review with meta-analysis. Physiother Can. 2012;64(4):397–413.CrossRefPubMedPubMedCentral
25.
Taub E, Miller NE, Novack TA. Cook EW,3rd, Fleming WC, Nepomuceno CS, et al. technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993;74(4):347–54.PubMed
26.
Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, et al. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008;7(1):33–40.CrossRefPubMedPubMedCentral
27.
Shaw SE, Morris DM, Uswatte G, McKay S, Meythaler JM, Taub E. Constraint-induced movement therapy for recovery of upper-limb function following traumatic brain injury. J Rehabil Res Dev. 2005;42(6):769.CrossRefPubMed
28.
Uswatte G, Taub E, Morris D, Barman J, Crago J. Contribution of the shaping and restraint components of constraint-induced movement therapy to treatment outcome. NeuroRehabil. 2006;21:147–56.
29.
Lindsay MP, Gubitz G, Bayley M, Hill MD, Davies-Schinkel C, Singh S, and Phillips S. Canadian best practice recommendations for stroke care (Update 2010). On behalf of the Canadian Stroke Strategy Best Practices and Standards Writing Group. 2010; Ottawa, Ontario Canada: Canadian Stroke Network.
30.
Miller E, Murray L, Richards L, Zorowitz R, Bakas T, Clark P, et al. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010;41:2402–48.CrossRefPubMed
31.
Walker J, Pink MJ. Occupational therapists and the use of constraint-induced movement therapy in neurological practice. Aust Occup Ther J. 2009;56(6):436–7.CrossRefPubMed
32.
Viana R, Teasell R. Barriers to the implementation of constraint-induced movement therapy into practice. Top Stroke Rehabil. 2012;19(2):104–14.CrossRefPubMed
33.
Brogardh C, Vestling M, Sjolund BH. Shortened constraint-induced movement therapy in subacute stroke - no effect of using a restraint: a randomized controlled study with independent observers. J Rehabil Med. 2009;41(4):231–6.CrossRefPubMed
34.
Brogardh C, Lexell J. A 1-year follow-up after shortened constraint-induced movement therapy with and without mitt poststroke. Arch Phys Med Rehabil. 2010;91(3):460–4.CrossRefPubMed
35.
Corbetta D, Sirtori V, Castellini G, Moja L, Gatti R. Constraint-induced movement therapy for upper limb (arm) recovery after stroke. Cochrane Database Syst Rev. 2015;10:CD004433.
36.
Lum PS, Taub E, Schwandt D, Postman M. Automated constraint-induced therapy extension (AutoCITE) for movement deficits after stroke. J Rehabil Res Dev. 2004;41(3):249.CrossRefPubMed
37.
Taub E, Lum PS, Hardin P, Mark VW, Uswatte G. AutoCITE: automated delivery of CI therapy with reduced effort by therapists. Stroke. 2005;36:1301–4.CrossRefPubMed
38.
Lum PS, Uswatte G, Taub E, Hardin P, Mark VW. A telerehabilitation approach to delivery of constraint-induced movement therapy. J Rehabil Res Dev. 2006;43(3):391–400.CrossRefPubMed
39.
Rand D, Givon N, Weingarden H, Nota A, Zeilig G. Eliciting upper extremity purposeful movements using video games: a comparison with traditional therapy for stroke rehabilitation. Neurorehabil Neural Repair. 2014;28(8):733–9.CrossRefPubMed
40.
Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015;12:CD008349.
41.
Brennan DM, Lum P, Uswatte G, Taub E, Gilmore BM, Barman J. A telerehabilitation platform for home-based automated therapy of arm function. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:1819–22.PubMed
42.
Hodics TM, Nakatsuka K, Upreti B, Alex A, Smith PS, Pezzullo JC. Wolf Motor function test for characterizing moderate to severe hemiparesis in stroke patients. Arch Phys Med Rehabil. 2012;93(11):1963–7.CrossRefPubMedPubMedCentral
43.
Taub E, Uswatte G, Bowman MH, Mark VW, Delgado A, Bryson C, et al. Constraint-induced movement therapy combined with conventional neurorehabilitation techniques in chronic stroke patients with plegic hands: a case series. Arch Phys Med Rehabil. 2013;94(1):86–94.CrossRefPubMed
44.
Skidmore ER, Holm MB, Whyte EM, Dew MA, Dawson D, Becker JT. The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. Neuropsychol Rehabil. 2011;21(2):208–23.CrossRefPubMedPubMedCentral
45.
Uswatte G, Taub E, Morris D, Light K, Thompson PA. The motor activity log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006;67(7):1189–94.CrossRefPubMed
46.
Whitall J, Savin DN Jr, Harris-Love M, Waller SM. Psychometric properties of a modified Wolf Motor function test for people with mild and moderate upper-extremity hemiparesis. Arch Phys Med Rehabil. 2006;87(5):656–60.CrossRefPubMed
47.
Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001;82(6):750–5.CrossRefPubMed
48.
Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001;32(7):1635–9.CrossRefPubMed
49.
Chen H, Chen CC, Hsueh I, Huang S, Hsieh C. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009;23(5):435–40.CrossRefPubMed
50.
Cella D, Lai JS, Nowinski CJ, Victorson D, Peterman A, Miller D, et al. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012;78(23):1860–7.CrossRefPubMedPubMedCentral
51.
Gershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, et al. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012;21(3):475–86.CrossRefPubMed
52.
Perez L, Huang J, Jansky L, Nowinski C, Victorson D, Peterman A, et al. Using focus groups to inform the Neuro-QOL measurement tool: exploring patient-centered, health-related quality of life concepts across neurological conditions. J Neurosci Nurs. 2007;39(6):342–53.CrossRefPubMed
53.
54.
Borstad AL N-LD. The Brief Kinesthesia test is feasible and sensitive: A study in stroke. Braz J Phys Ther. 2016;(In Press).
55.
Hunter JM, Mackin EJ, Callahan AD. Rehabilitation of the Hand: Surgery and Therapy. 4th edition ed: Mosby; 1995.
56.
Novak CB, Mackinnon SE, Williams JI, Kelly L. Establishment of reliability in the evaluation of hand sensibility. Plast Reconstr Surg. 1993;92(2):311–22.CrossRefPubMed
57.
Halar E, Hammond M, LaCava E, Camann C, Ward J. Sensory perception threshold measurement: an evaluation of semiobjective testing devices. Arch Phys Med Rehabil. 1987;68(8):499–507.PubMed
58.
Rolke R, Magerl W, Campbell KA, et al. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006;10(1):77.CrossRefPubMed
59.
60.
Dong Y, Sharma VK, Chan BP, Venketasubramanian N, Teoh HL, Seet RC, et al. The Montreal cognitive assessment (MoCA) is superior to the mini-mental state examination (MMSE) for the detection of vascular cognitive impairment after acute stroke. J Neurol Sci. 2010;299(1):15–8.
61.
Freitas S, Simoes MR, Alves L, Vicente M, Santana I. Montreal cognitive assessment (MoCA): validation study for vascular dementia. J Int Neuropsychol Soc. 2012;18(6):1031–40.CrossRefPubMed
62.
Webb AJ, Pendlebury ST, Li L, Simoni M, Lovett N, Mehta Z, et al. Validation of the Montreal cognitive assessment versus mini-mental state examination against hypertension and hypertensive arteriopathy after transient ischemic attack or minor stroke. Stroke. 2014;45(11):3337–42.
63.
Taub E, Uswatte G. Constraint-induced movement therapy: a family of neurorehabilitation treatments that harnesses the plasticity of the central nervous system. Neurologie und Rehabil. 2012;19(3):161–75.
64.
Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to treat motor disorders. Prog Brain Res. 2013;207:379–401.CrossRefPubMed
65.
Lin K, Hsieh Y, Wu C, Chen C, Jang Y, Liu J. Minimal detectable change and clinically important difference of the Wolf Motor function test in stroke patients. Neurorehabil Neural Repair. 2009;23(5):429–34.CrossRefPubMed
66.
67.
Page SJ, Levine P, Sisto S, Bond Q, Johnston MV. Stroke patients' and therapists' opinions of constraint-induced movement therapy. Clin Rehabil. 2002;16(1):55–60.CrossRefPubMed
Metadata
Title
Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis
Authors
Lynne V. Gauthier
Chelsea Kane
Alexandra Borstad
Nancy Strahl
Gitendra Uswatte
Edward Taub
David Morris
Alli Hall
Melissa Arakelian
Victor Mark
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2017
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-017-0888-0

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