Clinical trial NCT03228264: A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.
Official title: A Randomized Controlled, Evaluator-blinded, Multi-center Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Chronic Stroke
Post Stroke Seizure
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a randomized, controlled, evaluator-blinded multi-center superiority trial with two parallel groups and with word finding ability as primary endpoint at the end of the intervention. Aphasia outpatients will be recruited and randomly assigned to the experimental or control group. The randomization will be stratified by the study centre (Bern, Luzern) and the severity of aphasia (mild with a raw value/T-value smaller than 5/52, severe with a raw value/T-value greater or equal to 5/52 for the Token Test). Both groups will do a four weeks intensive tablet-delivered telerehabilitation training (2 hours a day).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of high-frequency short duration tablet-based speech and language therapy (teleSLT) mixed with cognitive training (teleCT) in chronic stroke patients. Recent studies suggest that chronic stroke patients benefit from SLT with high frequency and that cognitive abilities can play a role in sentence comprehension and production by individuals with aphasia. To investigate the effects of the distribution of training time for teleSLT and teleCT the investigators use two combinations. In the experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT whereas in the control group 20% of the training time will be devoted to teleSLT and 80% to teleCT. Both groups receive the same total amount and frequency of intervention but with different distributions. At three time points (pre-, post-test and 8 week follow-up) the patients' word finding ability is measured.

Detailed description: A recent Cochrane intervention review revealed evidence for the effectiveness of using speech and language therapy (SLT) for people with aphasia following stroke in terms of functional communication, receptive and expressive language. The authors highlight positive effects of higher training frequency on functional outcome. Also other authors emphasizes the importance of training frequency. In the meta-analysis with 968 patients the authors found that only intervention studies with more than five hours training per week lead to positive effects on speech and language function. They highlighted that it might be better to train short but with a high frequency than long with a low frequency. While some researchers emphasizes the benefit of early intervention, several studies found that also chronic stroke patients can benefit from intensive SLT. One possible approach to increase training frequency and duration is to complement therapist delivered usual care SLT (ucSLT) with telerehabilitation SLT (teleSLT) delivered in the patient's home.

Aphasia is frequently accompanied by deficits of working memory (WM), speed of processing (SP) and executive functions (EF). Recent studies suggest that these cognitive abilities can play a role in sentence comprehension and production by individuals with aphasia and that WM, SP and EF can be enhanced with intensive practice. The authors suggest that SLT therapy should be accompanied with cognitive training (CT). It remains however unclear what percentage of the training time should be devoted to SLT and to cognitive training respectively. For the current study the investigators will use two combinations of teleSLT and telerehabilitation cognitive training (teleCT), where one combination will have a higher percentage of time devoted to teleSLT and the other a higher percentage devoted to teleCT. The latter will serve as the control group to examine the effect of teleSLT.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or over.
* Diagnosis of stroke, onset of stroke at least 3 months prior to inclusion
* Diagnosis of aphasia due to stroke, as confirmed by a speech and language therapist.
* Raw value for the German version of the Token Test (De Renzi \& Vignolo, 1962) has to be smaller or equal to 8 (T-value smaller or equal to 60).
* Sufficient vision and cognitive ability to work with the teleSLT software (a simple matching task on the tablet computer will be used to test this).
* Written informed consent.

Exclusion Criteria:

* Any other pre-morbid speech and language disorder caused by a deficit other than stroke.
* Requirement for treatment in language other than German.
* Currently using a computer speech therapy software.

Primary outcomes:
measure: Understandability of verbal communication
timeFrame: Pre-test (Baseline, week 0)
measure: Understandability of verbal communication
timeFrame: Post-test (Change from Baseline at week 4)
measure: Understandability of verbal communication
timeFrame: 8 week follow-up (Change from Baseline at week 12)
Secondary outcomes:
measure: Intelligibility of verbal communication
timeFrame: Pre-test (Baseline, week 0)
measure: Intelligibility of verbal communication
timeFrame: Post-test (Change from Baseline at week 4)
measure: Intelligibility of verbal communication
timeFrame: 8 week follow-up (Change from Baseline at week 12)
measure: Impairment specific language measures
timeFrame: Pre-test (Baseline, week 0)
measure: Impairment specific language measures
timeFrame: Post-test (Change from Baseline at week 4)
measure: Impairment specific language measures
timeFrame: 8 week follow-up (Change from Baseline at week 12)
measure: Perceived quality of life
timeFrame: Pre-test (Baseline, week 0)
measure: Perceived quality of life
timeFrame: Post-test (Change from Baseline at week 4)
measure: Perceived quality of life
timeFrame: 8 week follow-up (Change from Baseline at week 12)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: ARTORG Center for Biomedical Engineering Research
city: Lucerne
country: Switzerland
facility: Center for Neurology and Neurorehabilitation
Study officials:
affiliation: Gerontechnology and Rehabilitation, ARTORG Centre for Biomedical Engineering Research
name: Tobias Nef, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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citation: Uslu AS, Gerber SM, Schmidt N, Rothlisberger C, Wyss P, Vanbellingen T, Schaller S, Wyss C, Koenig-Bruhin M, Berger T, Nyffeler T, Muri R, Nef T, Urwyler P. Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol. BMJ Open. 2020 Nov 11;10(11):e037702. doi: 10.1136/bmjopen-2020-037702.