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

Aphasia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228264
• Other study ID #: 2016-01577
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2022
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Chronic Stroke
• Post Stroke Seizure
• Seizures
• Stroke

Intervention

Device:
• teleSLT
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).
• teleCT
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.

Locations

Country	Name	City	State
Switzerland	ARTORG Center for Biomedical Engineering Research	Bern
Switzerland	Center for Neurology and Neurorehabilitation	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. Epub 2003 Mar 20. — View Citation

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.

Blomert L, Kean ML, Koster C, Schokker, J. Amsterdam-Nijmegen everyday language test: construction, reliability and validity. Aphasiology 8(4): 381-407, 1994.

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. Review. Update in: Cochrane Database Syst Rev. 2016;(6):CD000425. — View Citation

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. Review. — View Citation

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. — View Citation

DE RENZI E, VIGNOLO LA. The token test: A sensitive test to detect receptive disturbances in aphasics. Brain. 1962 Dec;85:665-78. — View Citation

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. Epub 2003 Jul 10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Zakariás 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-test (Baseline, week 0)
Primary	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.	Post-test (Change from Baseline at week 4)
Primary	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.	8 week follow-up (Change from Baseline at week 12)
Secondary	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.	Pre-test (Baseline, week 0)
Secondary	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.	Post-test (Change from Baseline at week 4)
Secondary	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.	8 week follow-up (Change from Baseline at week 12)
Secondary	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.	Pre-test (Baseline, week 0)
Secondary	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.	Post-test (Change from Baseline at week 4)
Secondary	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.	8 week follow-up (Change from Baseline at week 12)
Secondary	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.	Pre-test (Baseline, week 0)
Secondary	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.	Post-test (Change from Baseline at week 4)
Secondary	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.	8 week follow-up (Change from Baseline at week 12)