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Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial
BACKGROUND: The Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limi...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880095/ https://www.ncbi.nlm.nih.gov/pubmed/29606148 http://dx.doi.org/10.1186/s13063-018-2588-5 |
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author | Øra, Hege Prag Kirmess, Melanie Brady, Marian C. Winsnes, Ingvild Elisabeth Hansen, Silje Merethe Becker, Frank |
author_facet | Øra, Hege Prag Kirmess, Melanie Brady, Marian C. Winsnes, Ingvild Elisabeth Hansen, Silje Merethe Becker, Frank |
author_sort | Øra, Hege Prag |
collection | PubMed |
description | BACKGROUND: The Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limitations. Telerehabilitation could widen access to speech-language pathologists (SLPs) in geographically remote contexts and reduce the time spent on travel by the therapist and patient. The current academic literature within this field is in its infancy, with few trials of speech and language therapy (SLT) delivered by videoconference. Our pilot randomized controlled trial (RCT) will explore feasibility aspects and effectiveness of telerehabilitation for aphasia in addition to standard SLT. METHOD/DESIGN: Our study is a pragmatic, exploratory, pilot randomized controlled trial, where participants will be randomized to a telerehabilitation group or a control group. Both groups receive standard SLT (usual care) but the telerehabilitation group receives an additional 5 h of telerehabilitation per week over 4 weeks through videoconference. This additional telerehabilitation focuses on spoken language with an emphasis on word naming. We aim to include 40 patients in each group, with inclusion criteria being aphasia any time post stroke. Participants will be assessed blindly at pre-randomization (baseline), and 4 weeks and 4 months after randomization. The primary endpoint is naming ability 3 months after the completed intervention, measured by the Norwegian Basic Aphasia Assessment (NGA) naming subtest. Secondary endpoints include other subtests of the NGA, the VAST (Verb and Sentence Test) subtest sentence production, Communicative Effectiveness Index (CETI) and the Stroke and Aphasia Quality of Life scale (SAQOL-39). Experiences of patients and SLPs with telerehabilitation are assessed using questionnaires and semi-structured interviews. Statistical between group comparisons will be in line with an intention-to-treat analysis. DISCUSSION: This pilot RCT of intensive language training by videoconference will contribute new scientific evidence to the field of aphasia telerehabilitation. Here, we describe our trial which will explore the feasibility of telerehabilitation for aphasia as an intervention, our choice of primary and secondary outcome measures and proposed analyses. Our trial will provide information for the development and delivery of future definitive RCTs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02768922. Registered on 11 May 2016. Last updated on 17 November 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2588-5) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5880095 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-58800952018-04-04 Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial Øra, Hege Prag Kirmess, Melanie Brady, Marian C. Winsnes, Ingvild Elisabeth Hansen, Silje Merethe Becker, Frank Trials Study Protocol BACKGROUND: The Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limitations. Telerehabilitation could widen access to speech-language pathologists (SLPs) in geographically remote contexts and reduce the time spent on travel by the therapist and patient. The current academic literature within this field is in its infancy, with few trials of speech and language therapy (SLT) delivered by videoconference. Our pilot randomized controlled trial (RCT) will explore feasibility aspects and effectiveness of telerehabilitation for aphasia in addition to standard SLT. METHOD/DESIGN: Our study is a pragmatic, exploratory, pilot randomized controlled trial, where participants will be randomized to a telerehabilitation group or a control group. Both groups receive standard SLT (usual care) but the telerehabilitation group receives an additional 5 h of telerehabilitation per week over 4 weeks through videoconference. This additional telerehabilitation focuses on spoken language with an emphasis on word naming. We aim to include 40 patients in each group, with inclusion criteria being aphasia any time post stroke. Participants will be assessed blindly at pre-randomization (baseline), and 4 weeks and 4 months after randomization. The primary endpoint is naming ability 3 months after the completed intervention, measured by the Norwegian Basic Aphasia Assessment (NGA) naming subtest. Secondary endpoints include other subtests of the NGA, the VAST (Verb and Sentence Test) subtest sentence production, Communicative Effectiveness Index (CETI) and the Stroke and Aphasia Quality of Life scale (SAQOL-39). Experiences of patients and SLPs with telerehabilitation are assessed using questionnaires and semi-structured interviews. Statistical between group comparisons will be in line with an intention-to-treat analysis. DISCUSSION: This pilot RCT of intensive language training by videoconference will contribute new scientific evidence to the field of aphasia telerehabilitation. Here, we describe our trial which will explore the feasibility of telerehabilitation for aphasia as an intervention, our choice of primary and secondary outcome measures and proposed analyses. Our trial will provide information for the development and delivery of future definitive RCTs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02768922. Registered on 11 May 2016. Last updated on 17 November 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2588-5) contains supplementary material, which is available to authorized users. BioMed Central 2018-04-02 /pmc/articles/PMC5880095/ /pubmed/29606148 http://dx.doi.org/10.1186/s13063-018-2588-5 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Øra, Hege Prag Kirmess, Melanie Brady, Marian C. Winsnes, Ingvild Elisabeth Hansen, Silje Merethe Becker, Frank Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
title | Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
title_full | Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
title_fullStr | Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
title_full_unstemmed | Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
title_short | Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
title_sort | telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880095/ https://www.ncbi.nlm.nih.gov/pubmed/29606148 http://dx.doi.org/10.1186/s13063-018-2588-5 |
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