ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03228264
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Bern

July 12, 2017
July 24, 2017
March 7, 2018
June 2018
November 2020   (Final data collection date for primary outcome measure)
  • 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.
  • Word Finding Ability [ Time Frame: Pre-test (Baseline, week 0) ]
    The word finding ability is measured by naming of 100 personally relevant words presented on a computer screen. It is performed in a face-to-face interaction between the patients and the separate speech and language therapists and is evaluated by these therapists. The measurement takes place at the beginning of the intervention.
  • Word Finding Ability [ Time Frame: Post-test (Change from Baseline at week 4) ]
    The word finding ability is measured by naming of 100 personally relevant words presented on a computer screen. It is performed in a face-to-face interaction between the patients and the separate speech and language therapists and is evaluated by these therapists. The measurement takes place at the end of the intervention.
  • Word Finding Ability [ Time Frame: 8 week follow-up (Change from Baseline at week 12) ]
    The word finding ability is measured by naming of 100 personally relevant words presented on a computer screen. It is performed in a face-to-face interaction between the patients and the separate speech and language therapists and is evaluated by these therapists. The measurement takes place eight weeks after the intervention.
Complete list of historical versions of study NCT03228264 on ClinicalTrials.gov Archive Site
  • Intelligibility of verbal communication [ Time Frame: Pre-test (Baseline, week 0) ]
    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.
  • Intelligibility of verbal communication [ Time Frame: Post-test (Change from Baseline at week 4) ]
    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.
  • Intelligibility of verbal communication [ Time Frame: 8 week follow-up (Change from Baseline at week 12) ]
    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.
  • Impairment specific language measures [ Time Frame: Pre-test (Baseline, week 0) ]
    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.
  • Impairment specific language measures [ Time Frame: Post-test (Change from Baseline at week 4) ]
    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.
  • Impairment specific language measures [ Time Frame: 8 week follow-up (Change from Baseline at week 12) ]
    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.
  • Perceived quality of life [ Time Frame: Pre-test (Baseline, week 0) ]
    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.
  • Perceived quality of life [ Time Frame: Post-test (Change from Baseline at week 4) ]
    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.
  • Perceived quality of life [ Time Frame: 8 week follow-up (Change from Baseline at week 12) ]
    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.
  • Functional Communication [ Time Frame: Pre-test (Baseline, week 0) ]
    The functional communication is measured by observation of ten minutes' conversations structured around topics of personal interest. The therapy outcome measures (TOMS) activity scale is used to systematically rate conversational ability covering the four dimensions impairment, disability/activity, participation and well-being (Enderby, John, & Petheram, 2013). It is performed in a face-to-face interaction between the patients and the separate speech and language therapists and is evaluated by these therapists. The measurement takes place at the beginning of the intervention.
  • Functional Communication [ Time Frame: Post-test (Change from Baseline at week 4) ]
    The functional communication is measured by observation of ten minutes' conversations structured around topics of personal interest. The therapy outcome measures (TOMS) activity scale is used to systematically rate conversational ability covering the four dimensions impairment, disability/activity, participation and well-being (Enderby, John, & Petheram, 2013). It is performed in a face-to-face interaction between the patients and the separate speech and language therapists and is evaluated by these therapists. The measurement takes place at the end of the intervention.
  • Functional Communication [ Time Frame: 8 week follow-up (Change from Baseline at week 12) ]
    The functional communication is measured by observation of ten minutes' conversations structured around topics of personal interest. The therapy outcome measures (TOMS) activity scale is used to systematically rate conversational ability covering the four dimensions impairment, disability/activity, participation and well-being (Enderby, John, & Petheram, 2013). It is performed in a face-to-face interaction between the patients and the separate speech and language therapists and is evaluated by these therapists. The measurement takes place eight weeks after the intervention.
  • Change In Patient Perception Of Communication And Quality Of Life [ Time Frame: Post-test (First measurement, week 4) ]
    The Change in patient perception of communication and quality of life is assessed with the revised 20 items COAST self-reported questionnaire (Long, Hesketh, Paszek, Booth, & Bowen, 2008). The COAST consists of the three subscales "interactive communication", "overview of communication" and "impact and quality of life". In this study the total of the subscales is used to measure the change in patient perception of communication and quality of life. The COAST is performed in an interaction with the separate speech and language therapist and is evaluated by these therapists. The measurement takes place at the end of the intervention.
  • Change In Patient Perception Of Communication And Quality Of Life [ Time Frame: 8 week follow-up (Second measurement, week 12) ]
    The Change in patient perception of communication and quality of life is assessed with the revised 20 items COAST self-reported questionnaire (Long, Hesketh, Paszek, Booth, & Bowen, 2008). The COAST consists of the three subscales "interactive communication", "overview of communication" and "impact and quality of life". In this study the total of the subscales is used to measure the change in patient perception of communication and quality of life. The COAST is performed in an interaction with the separate speech and language therapist and is evaluated by these therapists. The measurement takes place eight weeks after the intervention.
Not Provided
Not Provided
 
A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
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 severety 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 (Outcomes Assessor)
Primary Purpose: Treatment
  • Aphasia
  • Chronic Stroke
  • Post Stroke Seizure
  • 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).
  • Device: 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.
  • Experimental: High teleSLT frequency
    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.
    Interventions:
    • Device: teleSLT
    • Device: teleCT
  • Active Comparator: Low teleSLT frequency
    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.
    Interventions:
    • Device: teleSLT
    • Device: teleCT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
November 2020
November 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Tobias Nef, Prof. Dr. +41 31 632 74 78 tobias.nef@artorg.unibe.ch
Contact: René Müri, Prof. Dr. +41 31 632 30 81 rene.mueri@insel.ch
Switzerland
 
 
NCT03228264
2016-01577
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University of Bern
University of Bern
Not Provided
Principal Investigator: Tabias Nef, Prof. Dr. Gerontechnology and Rehabilitation, ARTORG Centre for Biomedical Engineering Research
University of Bern
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP