Effect of a four-week virtual reality-based training versus conventional therapy on upper limb motor function after stroke: A multicenter parallel group randomized trial

Corina Schuster-Amft, Kynan Eng, Zorica Suica, Irene Thaler, Sandra Signer, Isabelle Lehmann, Ludwig Schmid, Michael A McCaskey, Miura Hawkins, Martin L Verra, Daniel Kiper, Corina Schuster-Amft, Kynan Eng, Zorica Suica, Irene Thaler, Sandra Signer, Isabelle Lehmann, Ludwig Schmid, Michael A McCaskey, Miura Hawkins, Martin L Verra, Daniel Kiper

Abstract

Background: Virtual reality-based training has found increasing use in neurorehabilitation to improve upper limb training and facilitate motor recovery.

Objective: The aim of this study was to directly compare virtual reality-based training with conventional therapy.

Methods: In a multi-center, parallel-group randomized controlled trial, patients at least 6 months after stroke onset were allocated either to an experimental group (virtual reality-based training) or a control group receiving conventional therapy (16x45 minutes within 4 weeks). The virtual reality-based training system replicated patients´ upper limb movements in real-time to manipulate virtual objects. Blinded assessors tested patients twice before, once during, and twice after the intervention up to 2-month follow-up for dexterity (primary outcome: Box and Block Test), bimanual upper limb function (Chedoke-McMaster Arm and Hand Activity Inventory), and subjective perceived changes (Stroke Impact Scale).

Results: 54 eligible patients (70 screened) participated (15 females, mean age 61.3 years, range 20-81 years, time since stroke 3.0±SD 3 years). 22 patients were allocated to the experimental group and 32 to the control group (3 drop-outs). Patients in the experimental and control group improved: Box and Block Test mean 21.5±SD 16 baseline to mean 24.1±SD 17 follow-up; Chedoke-McMaster Arm and Hand Activity Inventory mean 66.0±SD 21 baseline to mean 70.2±SD 19 follow-up. An intention-to-treat analysis found no between-group differences.

Conclusions: Patients in the experimental and control group showed similar effects, with most improvements occurring in the first two weeks and persisting until the end of the two-month follow-up period. The study population had moderate to severely impaired motor function at entry (Box and Block Test mean 21.5±SD 16). Patients, who were less impaired (Box and Block Test range 18 to 72) showed higher improvements in favor of the experimental group. This result could suggest that virtual reality-based training might be more applicable for such patients than for more severely impaired patients.

Trial registration: ClinicalTrials.gov NCT01774669.

Conflict of interest statement

All co-authors report grants from Swiss Commission for Technology and Innovation and non-financial support from YouRehab AG (now renamed REHA STIM MEDTEC AG) during the conduct of the study. KE and DK declare personal fees from YouRehab AG (now renamed REHA STIM MEDTEC AG) outside the submitted work. In addition, KE and DK have a patent US13060344 (Adjustable virtual reality system) with royalties paid to YouRehab AG (now renamed REHA STIM MEDTEC AG) and were co-founder and KE former CTO (part-time) of YouRehab AG (now renamed REHA STIM MEDTEC AG) during part of the study period. The study funding organization, the Swiss Commission for Technology and Innovation, had no authority over and was not involved in the study design; the collection, management, analysis or interpretation of data; the writing of the report; and the decision to submit the report for publication. The study sponsor (YouRehab AG (now renamed REHA STIM MEDTEC AG)) was involved in the study design. They did not write the study report and did not have authority over the decision to submit the study report for publication.

Figures

Fig 1. Patient flow chart.
Fig 1. Patient flow chart.
BS = Buergerspital Solothurn, IS = Inselspital Bern, Reha Rheinfelden Measurement sessions: twice within one to two weeks before intervention start (BL, T0), once after eight (T1) and after 16 (T2) intervention sessions, and after a two months follow-up period (FU).
Fig 2. Change in Box und Block…
Fig 2. Change in Box und Block Test: paretic hand.
Pre = Pre-intervention, T1 = after 8 training sessions, T2 = after 16 training sessions, FU = follow-up after two months.
Fig 3. Change in Chedoke McMaster Arm…
Fig 3. Change in Chedoke McMaster Arm and Hand Activity Inventory.
Pre = Pre-intervention, T1 = after 8 training sessions, T2 = after 16 training sessions, FU = follow-up after two months.

References

    1. Dimbwadyo-Terrer I, Trincado-Alonso F, de Los Reyes-Guzman A, Aznar MA, Alcubilla C, Perez-Nombela S, et al. Upper limb rehabilitation after spinal cord injury: a treatment based on a data glove and an immersive virtual reality environment. Disabil Rehabil Assist Technol. 2016;11(6):462–7. 10.3109/17483107.2015.1027293 .
    1. Kalron A, Fonkatz I, Frid L, Baransi H, Achiron A. The effect of balance training on postural control in people with multiple sclerosis using the CAREN virtual reality system: a pilot randomized controlled trial. Journal of NeuroEngineering and Rehabilitation. 2016;13(1):1–10. 10.1186/s12984-016-0124-y
    1. Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015;2:CD008349 10.1002/14651858.CD008349.pub3 .
    1. Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, et al. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010;41(7):1477–84. Epub 2010/05/29. STROKEAHA.110.584979 [pii] 10.1161/STROKEAHA.110.584979 .
    1. Schmidt RA. Motor control and learning: a behavioral emphasis. 2nd ed. Champaign, Illinois: Human Kinetics Publishers, Inc.; 1988. XI, 578 S. p.
    1. Feigenson JS, McDowell FH, Meese P, McCarthy ML, Greenberg SD. Factors influencing outcome and length of stay in a stroke rehabilitation unit. Part 1. Analysis of 248 unscreened patients—medical and functional prognostic indicators. Stroke. 1977;8(6):651–6. .
    1. Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011;(9):CD008349 Epub 2011/09/09. 10.1002/14651858.CD008349.pub2 .
    1. Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017;11:CD008349 10.1002/14651858.CD008349.pub4 .
    1. van Hedel HJA, Wick K, Eng K, Meyer-Heim A. Improving dexterity in children with cerebral palsy: Preliminary results of a randomised trial evaluating a glove based VR-system. [Poster]. In press 2011.
    1. Schuster-Amft C, Henneke A, Hartog-Keisker B, Holper L, Siekierka E, Chevrier E, et al. Intensive virtual reality-based training for upper limb motor function in chronic stroke: a feasibility study using a single case experimental design and fMRI. Disabil Rehabil: Assist Technol. 2014;10(5):385–92. 10.3109/17483107.2014.908963 .
    1. Schuster-Amft C, Eng K, Lehmann I, Schmid L, Kobashi N, Thaler I, et al. Using mixed methods to evaluate efficacy and user expectations of a virtual reality-based training system for upper-limb recovery in patients after stroke: a study protocol for a randomised controlled trial. Trials. 2014;15(1):350 Epub 2014/09/10. 1745-6215-15-350 [pii] 10.1186/1745-6215-15-350 .
    1. Jansa J, Pogacnik T, Gompertz P. An evaluation of the Extended Barthel Index with acute ischemic stroke patients. Neurorehabil Neural Repair. 2004;18(1):37–41. 10.1177/0888439003262287 .
    1. Oldfield RC. The assessment and analysis of handedness: the Edinburgh Inventory. Neuropsychologia. 1971;9(1):97–113. Epub 1971/03/01. .
    1. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189–98. .
    1. Plummer P, Morris ME, Dunai J. Assessment of unilateral neglect. Phys Ther. 2003;83(8):732–40.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348 10.1136/bmj.g1687
    1. Eng K, Siekierka E, Pyk P, Chevrier E, Hauser Y, Cameirao M, et al. Interactive visuo-motor therapy system for stroke rehabilitation. Med Biol Eng Comput. 2007;45(9):901–7. Epub 2007/08/10. 10.1007/s11517-007-0239-1 .
    1. Barreca S, Wolf SL, Fasoli S, Bohannon R. Treatment interventions for the paretic upper limb of stroke survivors: a critical review. Neurorehabilitation and neural repair. 2003;17(4):220–6. 10.1177/0888439003259415 .
    1. Luke C, Dodd K, Brock K. Outcomes of the Bobath concept on upper limb recovery following stroke. Clinical rehabilitation. 2004;18(8):888–98. 10.1191/0269215504cr793oa
    1. Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985;39 10.5014/ajot.39.6.386
    1. Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009;23 10.1177/1545968308331146
    1. Barreca S, Gowland CK, Stratford P, Huijbregts M, Griffiths J, Torresin W, et al. Development of the Chedoke Arm and Hand Activity Inventory: theoretical constructs, item generation, and selection. Top Stroke Rehabil. 2004;11(4):31–42. Epub 2004/12/14. 10.1310/JU8P-UVK6-68VW-CF3W .
    1. Barreca S, Stratford P, Masters L, Lambert CL, Griffiths J, McBay C. Validation of Three Shortened Versions of the Chedoke Arm and Hand Activity Inventory. Physiother Can. 2006;58:148–56. 10.2310/6640.2006.00031
    1. Barreca SR, Stratford PW, Lambert CL, Masters LM, Streiner DL. Test-retest reliability, validity, and sensitivity of the Chedoke arm and hand activity inventory: a new measure of upper-limb function for survivors of stroke. Arch Phys Med Rehabil. 2005;86(8):1616–22. 10.1016/j.apmr.2005.03.017 .
    1. Schuster C, Hahn S, Ettlin T. Objectively-assessed outcome measures: a translation and cross-cultural adaptation procedure applied to the Chedoke McMaster Arm and Hand Activity Inventory (CAHAI). BMC Med Res Methodol. 2010;10:106 Epub 2010/12/01. 1471-2288-10-106 [pii] 10.1186/1471-2288-10-106 ; PubMed Central PMCID: PMC3004924.
    1. Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999;30(10):2131–40. .
    1. Duncan PW, Wallace D, Studenski S, Lai SM, Johnson D. Conceptualization of a new stroke-specific outcome measure: The Stroke Impact Scale. Top Stroke Rehabil. 2001;8(2):19–33. 10.1310/BRHX-PKTA-0TUJ-UYWT .
    1. Lin K-c, Fu T, Wu C-y, Wang Y-h, Liu J-s, Hsieh C-j, et al. Minimal Detectable Change and Clinically Important Difference of the Stroke Impact Scale in Stroke Patients. Neurorehabil Neural Repair. 2010;24(5):486–92. 10.1177/1545968309356295
    1. Gowland C, VanHullenaar S, Torresin W, Moreland J, Vanspall B, Barreca S, et al. Chedoke-McMaster Stroke Assessment: development, validation, and administration manual Hamilton (ON): School of Rehabilitation Science, McMaster University; 1995.
    1. Gowland CA. Staging motor impairment after stroke. Stroke. 1990;21(9 Suppl):II19–21. .
    1. Faul F, Erdfelder E, Lang A-G, Buchner A. GPower. 3.0.8 ed. Düsseldorf: Heinrich Heine Universität; 2007.
    1. Powney M, Williamson P, Kirkham J, Kolamunnage-Dona R. A review of the handling of missing longitudinal outcome data in clinical trials. Trials. 2014;15:237 10.1186/1745-6215-15-237 ; PubMed Central PMCID: PMC4087243.
    1. Armijo-Olivo S, Warren S, Magee D. Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: a review. Phys Ther Rev. 2009;14:36–49. 10.1179/174328809X405928
    1. Armstrong RA. When to use the Bonferroni correction. Ophthalmic Physiol Opt. 2014;34(5):502–8. 10.1111/opo.12131 .
    1. Leonhart R. [Estimating effect sizes in clinical trials]. Rehabilitation. 2004;43(4):241–6. 10.1055/s-2004-828293 .
    1. Brunner I, Skouen JS, Hofstad H, Assmus J, Becker F, Sanders AM, et al. Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT. Neurology. 2017;89(24):2413–21. 10.1212/WNL.0000000000004744 .
    1. Winstein C, Lewthwaite R, Blanton SR, Wolf LB, Wishart L. Infusing motor learning research into neurorehabilitation practice: a historical perspective with case exemplar from the accelerated skill acquisition program. J Neurol Phys Ther. 2014;38(3):190–200. Epub 2014/05/16. 10.1097/NPT.0000000000000046 .
    1. Lehmann I, Baer G, Schuster-Amft C. Experience of an upper limb training program with a non-immersive virtual reality system in patients after stroke: a qualitative study. Physiother. 2017:In press.
    1. Stewart JC, Gordon J, Winstein CJ. Control of reach extent with the paretic and nonparetic arms after unilateral sensorimotor stroke: kinematic differences based on side of brain damage. Experimental Brain Research. 2014;232(7):2407–19. 10.1007/s00221-014-3938-5
    1. da Silva Ribeiro NM, Ferraz DD, Pedreira E, Pinheiro I, da Silva Pinto AC, Neto MG, et al. Virtual rehabilitation via Nintendo Wii(R) and conventional physical therapy effectively treat post-stroke hemiparetic patients. Top Stroke Rehabil. 2015;22(4):299–305. 10.1179/1074935714Z.0000000017 .
    1. Thielbar KO, Lord TJ, Fischer HC, Lazzaro EC, Barth KC, Stoykov ME, et al. Training finger individuation with a mechatronic-virtual reality system leads to improved fine motor control post-stroke. J Neuroeng Rehabil. 2014;11:171 10.1186/1743-0003-11-171 ; PubMed Central PMCID: PMC4292811.
    1. 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. Neurorehabilitation and neural repair. 2014;28(8):733–9. 10.1177/1545968314521008 .
    1. Siekierka EM, Eng K, Bassetti C, Blickenstorfer A, Cameirao MS, Dietz V, et al. New technologies and concepts for rehabilitation in the acute phase of stroke: a collaborative matrix. Neurodegener Dis. 2007;4(1):57–69. 10.1159/000100360 .
    1. Saposnik G, Cohen LG, Mamdani M, Pooyania S, Ploughman M, Cheung D, et al. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial. The Lancet Neurology. 2016. 10.1016/S1474-4422(16)30121-1
    1. Aminov A, Rogers JM, Middleton S, Caeyenberghs K, Wilson PH. What do randomized controlled trials say about virtual rehabilitation in stroke? A systematic literature review and meta-analysis of upper-limb and cognitive outcomes. J NeuroEng Rehabil. 2018;15(1):29 10.1186/s12984-018-0370-2
    1. Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3–5):281–99. .
    1. Verheyden G, Nieuwboer A, De Wit L, Thijs V, Dobbelaere J, Devos H, et al. Time course of trunk, arm, leg, and functional recovery after ischemic stroke. Neurorehabilitation and neural repair. 2008;22(2):173–9. 10.1177/1545968307305456 .
    1. Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, et al. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014;11:CD010820 Epub 2014/11/12. 10.1002/14651858.CD010820.pub2 .

Source: PubMed

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