Article Text

Protocol
Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol
  1. Arif Sinan Uslu1,
  2. Stephan M Gerber1,
  3. Nadine Schmidt1,
  4. Carina Röthlisberger1,
  5. Patric Wyss1,
  6. Tim Vanbellingen1,2,
  7. Sandra Schaller3,
  8. Corina Wyss3,
  9. Monica Koenig-Bruhin2,
  10. Thomas Berger4,
  11. Thomas Nyffeler2,
  12. René Müri3,
  13. Tobias Nef5,
  14. Prabitha Urwyler1,3,5
  1. 1Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland
  2. 2Neurocenter, Luzerner Kantonsspital, Luzern, Switzerland
  3. 3Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  4. 4Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland
  5. 5ARTORG Center for Biomedical Engineering, University of Bern, Bern, Switzerland
  1. Correspondence to Dr Prabitha Urwyler; prabitha.urwyler{at}artorg.unibe.ch

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.

  • rehabilitation medicine
  • stroke
  • neurological injury
  • neurology
  • telemedicine
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This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @prabithaUrwyler

  • Contributors ASU and SMG wrote the first draft of the manuscript. SMG was involved in the development of the teleSLT application. NS, CR and ASU are trained researchers in the current study and populated the database of the Bern Aphasia App. PW, PU and TN drafted the application for ethics approval. SS, CW and MK-B are the involved speech and language therapists and were involved in the conception of the study together with PU, TV, TB, TNy, RM and TN. TNy is the principal investigator at trial site Lucerne, RM, PU are principal investigators at trial site Bern, and TN is the sponsor investigator.

  • Funding The present study is partially funded by the Interdisciplinary Grants at the University of Bern (UniBE ID Grants 2018), Switzerland.

  • 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.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.