Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol

Arif Sinan Uslu, Stephan M Gerber, Nadine Schmidt, Carina Röthlisberger, Patric Wyss, Tim Vanbellingen, Sandra Schaller, Corina Wyss, Monica Koenig-Bruhin, Thomas Berger, Thomas Nyffeler, René Müri, Tobias Nef, Prabitha Urwyler, Arif Sinan Uslu, Stephan M Gerber, Nadine Schmidt, Carina Röthlisberger, Patric Wyss, Tim Vanbellingen, Sandra Schaller, Corina Wyss, Monica Koenig-Bruhin, Thomas Berger, Thomas Nyffeler, René Müri, Tobias Nef, Prabitha Urwyler

Abstract

Introduction: Aphasia is a common language disorder acquired after stroke that reduces the quality of life of affected patients. The impairment is frequently accompanied by a deficit in cognitive functions. The state-of-the-art therapy is speech and language therapy but recent findings highlight positive effects of high-frequency therapy. Telerehabilitation has the potential to enable high-frequency therapy for patients at home. This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training. We hypothesise that patients training with high-frequency teleSLT will show higher improvement in language functions and quality of life compared with patients with high-frequency tele-rehabilitative cognitive training (teleCT).

Methods and analysis: This study is a randomised controlled, evaluator-blinded multicentre superiority trial comparing the outcomes following either high-frequency teleSLT or teleCT. A total of 100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups. Both groups will train over a period of 4 weeks for 2 hours per day. Patients in the experimental condition will devote 80% of their training time to teleSLT and the remaining 20% (24 min/day) to teleCT, vice versa for patients in the control condition. The primary outcome measure is the understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming. Other outcomes measures are quality of life and acceptance (usability and subjective experience) of the teleSLT system.

Ethics and dissemination: This study is approved by the Ethics Committee Bern (ID 2016-01577). Results will be submitted to a peer-reviewed journal.

Trial registration number: NCT03228264.

Keywords: neurological injury; neurology; rehabilitation medicine; stroke; telemedicine.

Conflict of interest statement

Competing interests: SMG was involved in the development of the Bern Aphasia App. NS, CR and ASU were involved in populating (exercises) the Bern Aphasia App.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Standard Protocol Items: Recommendations for Interventional Trials—schedule of enrolment, allocation, intervention and outcome measures. ANELT, Amsterdam Nijmegen Everyday Language Test; BNT, Boston Naming Test; CG, Control Group; EG, Experimental Group; IMI, Intrinsic Motivation Inventory; SAPS, Sprachsystematisches APhasie Screening; SAQOL, Stroke and Aphasia quality of life; SLT, Speech and Language Therapy; SUS, System Usability Scale.
Figure 2
Figure 2
Exercise of the type anagram. (A) Screen appearing when exercise was selected. (B) Solving the exercise using drag and drop on touchscreen. (C) Feedback after incorrect response. (D) Feedback after correct response.
Figure 3
Figure 3
Steps of the computerised adaptive testing algorithm used to adapt task difficulty.
Figure 4
Figure 4
Procedure of the flow free puzzle game.
Figure 5
Figure 5
Procedure of the match three puzzle game.

References

    1. WHO Global health estimates 2016: deaths by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organisation, 2018.
    1. Engelter ST, Gostynski M, Papa S, et al. . Epidemiology of aphasia attributable to first ischemic stroke: incidence, severity, fluency, etiology, and thrombolysis. Stroke 2006;37:1379–84. 10.1161/01.STR.0000221815.64093.8c
    1. Brady MC, Kelly H, Godwin J, et al. . Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev 2016;24:CD000425 10.1002/14651858.CD000425.pub4
    1. Dijkerman HC, Wood VA, Hewer RL. Long-term outcome after discharge from a stroke rehabilitation unit. J R Coll Physicians Lond 1996;30:538–46.
    1. Lam JMC, Wodchis WP. The relationship of 60 disease diagnoses and 15 conditions to preference-based health-related quality of life in Ontario hospital-based long-term care residents. Med Care 2010;48:380–7. 10.1097/MLR.0b013e3181ca2647
    1. Teasell RW, Foley NC, Bhogal SK, et al. . An evidence-based review of stroke rehabilitation. Top Stroke Rehabil 2003;10:29–58. 10.1310/8YNA-1YHK-YMHB-XTE1
    1. Code C, Torney A, Gildea-Howardine E, et al. . Outcome of a one-month therapy intensive for chronic aphasia: variable individual responses. Semin Speech Lang 2010;31:021–33. 10.1055/s-0029-1244950
    1. Kendall DL, Oelke M, Brookshire CE, et al. . The influence of phonomotor treatment on word retrieval abilities in 26 individuals with chronic aphasia: an open trial. J Speech Lang Hear Res 2015;58:798–812. 10.1044/2015_JSLHR-L-14-0131
    1. Breitenstein C, Grewe T, Flöel A, et al. . Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. Lancet 2017;389:1528–38. 10.1016/S0140-6736(17)30067-3
    1. Des Roches CA, Balachandran I, Ascenso EM, et al. . Effectiveness of an impairment-based individualized rehabilitation program using an iPad-based software platform. Front Hum Neurosci 2014;8:1015. 10.3389/fnhum.2014.01015
    1. Aftonomos LB, Steele RD, Wertz RT. Promoting recovery in chronic aphasia with an interactive technology. Arch Phys Med Rehabil 1997;78:841–6. 10.1016/S0003-9993(97)90197-0
    1. Hoover EL, Carney A. Integrating the iPad into an intensive, comprehensive aphasia program. Semin Speech Lang 2014;35:25–37. 10.1055/s-0033-1362990
    1. Kurland J, Wilkins AR, Stokes P. iPractice: piloting the effectiveness of a tablet-based home practice program in aphasia treatment. Semin Speech Lang 2014;35:51–64. 10.1055/s-0033-1362991
    1. Szabo G, Dittelman J. Using mobile technology with individuals with aphasia: native iPad features and everyday apps. Semin Speech Lang 2014;35:5–16. 10.1055/s-0033-1362993
    1. Spaccavento S, Marinelli CV, Nardulli R, et al. . Attention deficits in stroke patients: the role of lesion characteristics, time from stroke, and concomitant neuropsychological deficits. Behav Neurol 2019;2019:7835710. 10.1155/2019/7835710
    1. Gonçalves APB, Mello C, Pereira AH, et al. . Executive functions assessment in patients with language impairment a systematic review. Dement Neuropsychol 2018;12:272–83. 10.1590/1980-57642018dn12-030008
    1. Brownsett SLE, Warren JE, Geranmayeh F, et al. . Cognitive control and its impact on recovery from aphasic stroke. Brain 2014;137:242–54. 10.1093/brain/awt289
    1. Fridriksson J, Nettles C, Davis M, et al. . Functional communication and executive function in aphasia. Clin Linguist Phon 2006;20:401–10. 10.1080/02699200500075781
    1. Schumacher R, Halai AD, Lambon Ralph MA. Assessing and mapping language, attention and executive multidimensional deficits in stroke aphasia. Brain 2019;142:3202–16. 10.1093/brain/awz258
    1. Caplan D, Waters G. Memory mechanisms supporting syntactic comprehension. Psychon Bull Rev 2013;20:243–68. 10.3758/s13423-012-0369-9
    1. Crotty M, George S. Retraining visual processing skills to improve driving ability after stroke. Arch Phys Med Rehabil 2009;90:2096–102. 10.1016/j.apmr.2009.08.143
    1. Zakariás L, Keresztes A, Marton K, et al. . Positive effects of a computerised working memory and executive function training on sentence comprehension in aphasia. Neuropsychol Rehabil 2018;28:369–86. 10.1080/09602011.2016.1159579
    1. Engelhardt PE, Nigg JT, Ferreira F. Executive function and intelligence in the resolution of temporary syntactic ambiguity: an individual differences investigation. Q J Exp Psychol 2017;70:1263–81. 10.1080/17470218.2016.1178785
    1. Yoo H, Dickey MW. Aging effects and working memory in Garden-Path recovery. Clin Arch Commun Disord 2017;2:91–102. 10.21849/cacd.2017.00122
    1. Nouchi R, Taki Y, Takeuchi H, et al. . Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial. PLoS One 2013;8:e55518. 10.1371/journal.pone.0055518
    1. Salis C, Hwang F, Howard D, et al. . Short-term and working memory treatments for improving sentence comprehension in aphasia: a review and a replication study. Semin Speech Lang 2017;38:29–39. 10.1055/s-0036-1597262
    1. Januth S. Development and Evaluation of a New Tablet Computer Application for the Therapy of Brain-Injured Patients with Aphasia [Master]. Bern: University of Bern, 2015.
    1. Gerber SM, Schütz N, Uslu AS, et al. . Therapist-Guided tablet-based Telerehabilitation for patients with aphasia: proof-of-concept and usability study. JMIR Rehabil Assist Technol 2019;6:e13163. 10.2196/13163
    1. Nef T, Chesham A, Schütz N, et al. . Development and evaluation of Maze-Like puzzle games to assess cognitive and motor function in aging and neurodegenerative diseases. Front Aging Neurosci 2020;12:87. 10.3389/fnagi.2020.00087
    1. Chesham A, Gerber SM, Schütz N, et al. . Search and match task: development of a Taskified Match-3 puzzle game to assess and practice visual search. JMIR Serious Games 2019;7:e13620. 10.2196/13620
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke 2003;34:987–93. 10.1161/01.STR.0000062343.64383.D0
    1. Kaplan EL, Goodglass H, Weintraub S. The Boston naming test. Philadelphia: Lea & Febiger, 1983.
    1. Palmer R, Enderby P, Cooper C, et al. . Computer therapy compared with usual care for people with long-standing aphasia poststroke: a pilot randomized controlled trial. Stroke 2012;43:1904–11. 10.1161/STROKEAHA.112.650671
    1. Green CS, Strobach T, Schubert T. On methodological standards in training and transfer experiments. Psychol Res 2014;78:756–72. 10.1007/s00426-013-0535-3
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Blomert L, Buslach DC. Amsterdam-Nijmegen Everyday Language Test(ANELT) - Deutsche Fassung. Lisse, The Netherlands: Swets & Zeitlinger, 1994.
    1. Blomert L, Kean ML, Koster C, et al. . Amsterdam—Nijmegen everyday language test: construction, reliability and validity. Aphasiology 1994;8:381–407. 10.1080/02687039408248666
    1. Blömer F, Pesch A, Willmes K, et al. . Das sprachsystematische Aphasiescreening (SAPS): Konstruktionseigenschaften und erste Evaluierung. Zeitschrift für Neuropsychologie 2013;24:139–48. 10.1024/1016-264X/a000101
    1. De Renzi E, Vignolo LA. The Token test: a sensitive test to detect receptive disturbances in aphasics. Brain 1962;85:665–78. 10.1093/brain/85.4.665
    1. Fastenau PS, Denburg NL, Mauer BA. Parallel short forms for the Boston naming test: psychometric properties and norms for older adults. J Clin Exp Neuropsychol 1998;20:828–34. 10.1076/jcen.20.6.828.1105
    1. Gallaher AJ. Temporal reliability of aphasic performance on the Token test. Brain Lang 1979;7:34–41. 10.1016/0093-934X(79)90004-X
    1. Orgass B, Poeck K. Clinical validation of a new test for aphasia: an experimental study on the Token test. Cortex 1966;2:222–43. 10.1016/S0010-9452(66)80005-9
    1. Hilari K, Byng S, Lamping DL, et al. . Stroke and aphasia quality of life scale-39 (SAQOL-39). Stroke 2003;34:1944–50. 10.1161/01.STR.0000081987.46660.ED
    1. Brooke J. Jordan PW, Thomas B, Weerdmeester BA, et al., SUS-A quick and dirty usability scale. London: Taylor & Francis, 1996: 189–94.
    1. Ryan RM. Control and information in the intrapersonal sphere: an extension of cognitive evaluation theory. J Pers Soc Psychol 1982;43:450–61. 10.1037/0022-3514.43.3.450
    1. Wald A. Sequential analysis. New York: Wiley, 1947.
    1. Chlond MJ. Puzzle-IP satisfied. INFORMS Transactions on Education 2014;14:140–2.
    1. Cunningham R, Alex L, Frederick C. Studying human relatedness through a shared gaming experience. Paper presented at the Proceedings of the Human Factors and Ergonomics Society Annual Meeting, 2015.
    1. Oei AC, Patterson MD. Enhancing cognition with video games: a multiple game training study. PLoS One 2013;8:e58546. 10.1371/journal.pone.0058546
    1. Sydes MR, Spiegelhalter DJ, Altman DG, et al. . Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials 2004;1:60–79. 10.1191/1740774504cn004rr

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