AphasiaNCT03228264

A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.

A study testing teleSLT and teleCT in people with Aphasia and Chronic Stroke, run by University of Bern at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Aphasia, Chronic Stroke, Post Stroke Seizure
What is being tested?: teleSLT and teleCT
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 2 sitesSwitzerland
Study dates: 25 Sep 2018to 1 Nov 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

ARTORG Center for Biomedical Engineering Research
Bern, 3008
Center for Neurology and Neurorehabilitation
Lucerne, 6000

Other trials in Switzerland

About this study

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.

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.

Read the 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.

Conditions: Aphasia, Chronic Stroke, Post Stroke Seizure
Being tested: teleSLT, teleCT
Medical subject headings: Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

teleSLTDevice
The teleSLT intervention consists of a daily training session with a tablet computer at the patients' home. The teleSLT application that will be used for this study was developed within a multidisciplinary team of speech and language therapists, neurologists and computer engineers that have transferred well-established SLT exercises to a tablet computer. The investigators call this application Bern Aphasia App (BAA). During the four weeks the training time with the BAA differs between the two arms. The experimental group trains for 96 minutes per day (80% of two hours) and the control group for 24 minutes per day (20% of two hours).
teleCTDevice
For the cognitive training the investigators will use two custom-made versions of popular commercial casual puzzle video games: Flow Free (Big Duck Games LCC) and Bejeweled (PopCap Games). The video games are also delivered on tablet-computers. Again, during the four weeks the training time differs between the two arms. The experimental group trains for 24 minutes and the control group for 96 minutes per day.

Study groups in NCT03228264
Study group	Role	What they receive
High teleSLT frequency	Experimental	During four weeks all patients will do a daily two-hour training session with a tablet computer (consisting of teleSLT and teleCT) at their home. In the experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT. Both groups receive the same amount of ucSLT. Receives: Device: teleSLT; Device: teleCT
Low teleSLT frequency	Active comparator	During four weeks all patients will do a daily two-hour training session with a tablet computer (consisting of teleSLT and teleCT) at their home. In the control group 20% of the training time will be devoted to teleSLT and 80% to teleCT. Both groups receive the same amount of ucSLT. Receives: Device: teleSLT; Device: teleCT

What is being measured

The primary outcome is the main question the study is designed to answer.

Understandability of verbal communication
The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the beginning of the intervention.
Measured: Pre-test (Baseline, week 0)
Understandability of verbal communication
The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the end of the intervention.
Measured: Post-test (Change from Baseline at week 4)
Understandability of verbal communication
The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place eight weeks after the intervention.
Measured: 8 week follow-up (Change from Baseline at week 12)

Secondary outcomes (9)

Intelligibility of verbal communication
The intelligibility of verbal communication is assessed with the B-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios (same situation as for the A-scale of ANELT) are scored with respect to the intelligibility of the utterance, i.e. the perception of the utterance independent of the content or the meaning (Blomert et al., 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the beginning of the intervention.
Measured: Pre-test (Baseline, week 0)
Intelligibility of verbal communication
The intelligibility of verbal communication is assessed with the B-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios (same situation as for the A-scale of ANELT) are scored with respect to the intelligibility of the utterance, i.e. the perception of the utterance independent of the content or the meaning (Blomert et al., 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the end of the intervention.
Measured: Post-test (Change from Baseline at week 4)
Intelligibility of verbal communication
The intelligibility of verbal communication is assessed with the B-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios (same situation as for the A-scale of ANELT) are scored with respect to the intelligibility of the utterance, i.e. the perception of the utterance independent of the content or the meaning (Blomert et al., 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place eight weeks after the intervention.
Measured: 8 week follow-up (Change from Baseline at week 12)
Impairment specific language measures
The impairment specific language measures are assessed with "Sprachsystematisches APhasie Screening" (SAPS). The SAPS assesses comprehension (receptive) and production (expressive) abilities in the domains of phonetics and phonology (sub-lexical level), lexicon and semantic (lexical level) and morphology and syntax (morpho-syntactic level). For both modules (receptive and expressive) all three levels are divided into three difficulty levels. Based on these assessed comprehension and production abilities on all three levels it is possible to derive and evaluate disorder specific treatments (Blömer, Pesch, Willmes, Huber, Springer, \& Abel, 2013). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the beginning of the intervention.
Measured: Pre-test (Baseline, week 0)
Impairment specific language measures
The impairment specific language measures are assessed with "Sprachsystematisches APhasie Screening" (SAPS). The SAPS assesses comprehension (receptive) and production (expressive) abilities in the domains of phonetics and phonology (sub-lexical level), lexicon and semantic (lexical level) and morphology and syntax (morpho-syntactic level). For both modules (receptive and expressive) all three levels are divided into three difficulty levels. Based on these assessed comprehension and production abilities on all three levels it is possible to derive and evaluate disorder specific treatments (Blömer, Pesch, Willmes, Huber, Springer, \& Abel, 2013). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the end of the intervention.
Measured: Post-test (Change from Baseline at week 4)
Impairment specific language measures
The impairment specific language measures are assessed with "Sprachsystematisches APhasie Screening" (SAPS). The SAPS assesses comprehension (receptive) and production (expressive) abilities in the domains of phonetics and phonology (sub-lexical level), lexicon and semantic (lexical level) and morphology and syntax (morpho-syntactic level). For both modules (receptive and expressive) all three levels are divided into three difficulty levels. Based on these assessed comprehension and production abilities on all three levels it is possible to derive and evaluate disorder specific treatments (Blömer, Pesch, Willmes, Huber, Springer, \& Abel, 2013). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place eight weeks after the intervention.
Measured: 8 week follow-up (Change from Baseline at week 12)
Perceived quality of life
The perceived quality of life is assessed with the Stroke and Aphasia Quality of Life Scale with 39 items in total (SAQOL-39) which is an interview-administered self-report scale consisting of the four subdomains physical, psychosocial, communication and energy (Hilari, Byng, \& Smith, 2003). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the beginning of the intervention.
Measured: Pre-test (Baseline, week 0)
Perceived quality of life
The perceived quality of life is assessed with the Stroke and Aphasia Quality of Life Scale with 39 items in total (SAQOL-39) which is an interview-administered self-report scale consisting of the four subdomains physical, psychosocial, communication and energy (Hilari, Byng, \& Smith, 2003). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the end of the intervention.
Measured: Post-test (Change from Baseline at week 4)
Perceived quality of life
The perceived quality of life is assessed with the Stroke and Aphasia Quality of Life Scale with 39 items in total (SAQOL-39) which is an interview-administered self-report scale consisting of the four subdomains physical, psychosocial, communication and energy (Hilari, Byng, \& Smith, 2003). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place eight weeks after the intervention.
Measured: 8 week follow-up (Change from Baseline at week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 20181 Nov 2021

First posted24 Jul 2017
Study start25 Sep 2018
Primary completion1 Nov 2021
Study completion1 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for AphasiaStudies of the same condition, open and under way.
More trials run by University of BernThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03228264
Sponsor's protocol ID: 2016-01577
Other IDs: 2016
Status last verified: Nov 2022
First submitted: 12 Jul 2017
Last updated: 10 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
PubMed 12649521
Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
PubMed 22592672
Caplan D, Waters G. Memory mechanisms supporting syntactic comprehension. Psychon Bull Rev. 2013 Apr;20(2):243-68. doi: 10.3758/s13423-012-0369-9.
PubMed 23319178
Crotty M, George S. Retraining visual processing skills to improve driving ability after stroke. Arch Phys Med Rehabil. 2009 Dec;90(12):2096-102. doi: 10.1016/j.apmr.2009.08.143.
PubMed 19969174
Kendall DL, Oelke M, Brookshire CE, Nadeau SE. The Influence of Phonomotor Treatment on Word Retrieval Abilities in 26 Individuals With Chronic Aphasia: An Open Trial. J Speech Lang Hear Res. 2015 Jun;58(3):798-812. doi: 10.1044/2015_JSLHR-L-14-0131.
PubMed 25766309
Sandberg CW, Bohland JW, Kiran S. Changes in functional connectivity related to direct training and generalization effects of a word finding treatment in chronic aphasia. Brain Lang. 2015 Nov;150:103-16. doi: 10.1016/j.bandl.2015.09.002. Epub 2015 Sep 20.
PubMed 26398158
Wang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.
PubMed 25378426
Zakarias L, Keresztes A, Marton K, Wartenburger I. Positive effects of a computerised working memory and executive function training on sentence comprehension in aphasia. Neuropsychol Rehabil. 2018 Apr;28(3):369-386. doi: 10.1080/09602011.2016.1159579. Epub 2016 Mar 21.
PubMed 26999324
Blomert L, Kean ML, Koster C, Schokker, J. Amsterdam-Nijmegen everyday language test: construction, reliability and validity. Aphasiology 8(4): 381-407, 1994.
Blömer F, Pesch A, Willmes K, Huber W, Springer L, Abel S. Das sprachsystematische Aphasiescreening (SAPS): Konstruktionseigenschaften und erste Evaluierung. Zeitschrift für Neuropsychologie 24(3): 139-148, 2013.
Hilari K, Byng S, Lamping DL, Smith SC. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity. Stroke. 2003 Aug;34(8):1944-50. doi: 10.1161/01.STR.0000081987.46660.ED. Epub 2003 Jul 10.
PubMed 12855827
DE RENZI E, VIGNOLO LA. The token test: A sensitive test to detect receptive disturbances in aphasics. Brain. 1962 Dec;85:665-78. doi: 10.1093/brain/85.4.665. No abstract available.
PubMed 14026018
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.
PubMed 33177134

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke

All Aphasia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03228264
Acronym / sponsor ID: 2016-01577
Conditions: Aphasia, Chronic Stroke, Post Stroke Seizure
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of BernUniversity, hospital or other
Study start: 25 Sep 2018 (actual)
Primary completion: 1 Nov 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 24 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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).

Arm	Type	Receives
High teleSLT frequency	Experimental	Device: teleSLT, Device: teleCTDuring four weeks all patients will do a daily two-hour training session with a tablet computer (consisting of teleSLT and teleCT) at their home. In the experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT. Both groups receive the same amount of ucSLT.
Low teleSLT frequency	Active comparator	Device: teleSLT, Device: teleCTDuring four weeks all patients will do a daily two-hour training session with a tablet computer (consisting of teleSLT and teleCT) at their home. In the control group 20% of the training time will be devoted to teleSLT and 80% to teleCT. Both groups receive the same amount of ucSLT.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
teleSLTThe teleSLT intervention consists of a daily training session with a tablet computer at the patients' home. The teleSLT application that will be used for this study was developed within a multidisciplinary team of speech and language therapists, neurologists and computer engineers that have transferred well-established SLT exercises to a tablet computer. The investigators call this application Bern Aphasia App (BAA). During the four weeks the training time with the BAA differs between the two arms. The experimental group trains for 96 minutes per day (80% of two hours) and the control group for 24 minutes per day (20% of two hours).	Device	High teleSLT frequency, Low teleSLT frequency
teleCTFor the cognitive training the investigators will use two custom-made versions of popular commercial casual puzzle video games: Flow Free (Big Duck Games LCC) and Bejeweled (PopCap Games). The video games are also delivered on tablet-computers. Again, during the four weeks the training time differs between the two arms. The experimental group trains for 24 minutes and the control group for 96 minutes per day.	Device	High teleSLT frequency, Low teleSLT frequency

Primary outcome

Understandability of verbal communication
Time frame: Pre-test (Baseline, week 0)
The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the beginning of the intervention.
Understandability of verbal communication
Time frame: Post-test (Change from Baseline at week 4)
The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the end of the intervention.
Understandability of verbal communication
Time frame: 8 week follow-up (Change from Baseline at week 12)
The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place eight weeks after the intervention.

9 secondary outcomes

Intelligibility of verbal communication
Time frame: Pre-test (Baseline, week 0)
Intelligibility of verbal communication
Time frame: Post-test (Change from Baseline at week 4)
Intelligibility of verbal communication
Time frame: 8 week follow-up (Change from Baseline at week 12)
Impairment specific language measures
Time frame: Pre-test (Baseline, week 0)
Impairment specific language measures
Time frame: Post-test (Change from Baseline at week 4)
Impairment specific language measures
Time frame: 8 week follow-up (Change from Baseline at week 12)
Perceived quality of life
Time frame: Pre-test (Baseline, week 0)
Perceived quality of life
Time frame: Post-test (Change from Baseline at week 4)
Perceived quality of life
Time frame: 8 week follow-up (Change from Baseline at week 12)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
Background: PubMed 12649521Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
Background: PubMed 22592672Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
Background: PubMed 23319178Caplan D, Waters G. Memory mechanisms supporting syntactic comprehension. Psychon Bull Rev. 2013 Apr;20(2):243-68. doi: 10.3758/s13423-012-0369-9.
Background: PubMed 19969174Crotty M, George S. Retraining visual processing skills to improve driving ability after stroke. Arch Phys Med Rehabil. 2009 Dec;90(12):2096-102. doi: 10.1016/j.apmr.2009.08.143.
Background: PubMed 25766309Kendall DL, Oelke M, Brookshire CE, Nadeau SE. The Influence of Phonomotor Treatment on Word Retrieval Abilities in 26 Individuals With Chronic Aphasia: An Open Trial. J Speech Lang Hear Res. 2015 Jun;58(3):798-812. doi: 10.1044/2015_JSLHR-L-14-0131.
Background: PubMed 26398158Sandberg CW, Bohland JW, Kiran S. Changes in functional connectivity related to direct training and generalization effects of a word finding treatment in chronic aphasia. Brain Lang. 2015 Nov;150:103-16. doi: 10.1016/j.bandl.2015.09.002. Epub 2015 Sep 20.
Background: PubMed 25378426Wang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.
Background: PubMed 26999324Zakarias L, Keresztes A, Marton K, Wartenburger I. Positive effects of a computerised working memory and executive function training on sentence comprehension in aphasia. Neuropsychol Rehabil. 2018 Apr;28(3):369-386. doi: 10.1080/09602011.2016.1159579. Epub 2016 Mar 21.
BackgroundBlomert L, Kean ML, Koster C, Schokker, J. Amsterdam-Nijmegen everyday language test: construction, reliability and validity. Aphasiology 8(4): 381-407, 1994.
BackgroundBlömer F, Pesch A, Willmes K, Huber W, Springer L, Abel S. Das sprachsystematische Aphasiescreening (SAPS): Konstruktionseigenschaften und erste Evaluierung. Zeitschrift für Neuropsychologie 24(3): 139-148, 2013.
Background: PubMed 12855827Hilari K, Byng S, Lamping DL, Smith SC. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity. Stroke. 2003 Aug;34(8):1944-50. doi: 10.1161/01.STR.0000081987.46660.ED. Epub 2003 Jul 10.
Background: PubMed 14026018DE RENZI E, VIGNOLO LA. The token test: A sensitive test to detect receptive disturbances in aphasics. Brain. 1962 Dec;85:665-78. doi: 10.1093/brain/85.4.665. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tobias Nef, Prof. Dr. principal investigator

Gerontechnology and Rehabilitation, ARTORG Centre for Biomedical Engineering Research

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing teleSLT and teleCT in people with Aphasia and Chronic Stroke, run by University of Bern at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Understandability of verbal communication (time frame: Pre-test (Baseline, week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228264, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.