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Randomized Controlled Trial
. 2020 Nov 11;10(11):e037702.
doi: 10.1136/bmjopen-2020-037702.

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

Affiliations
Randomized Controlled Trial

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

Arif Sinan Uslu et al. BMJ Open. .

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.

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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.

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

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