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

This study is not yet open for participant recruitment.
Verified November 2017 by University of Bern
Sponsor:
ClinicalTrials.gov Identifier:
NCT03228264
First Posted: July 24, 2017
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
University of Bern
  Purpose
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.

Condition Intervention
Aphasia Chronic Stroke Post Stroke Seizure Behavioral: ucSLT Device: teleSLT Device: teleCT

Study Type: Interventional
Study Design: 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. Both groups will do a four weeks intensive tablet-delivered telerehabilitation training (1 hour a day) additional to a face-to-face therapy session of 45 minutes once a week.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High teleSLT frequency
During four weeks all patients will receive a 45 minutes ucSLT once a week and will do a daily one-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.
Behavioral: ucSLT
The psychological intervention consists of usual care SLT (ucSLT). During four weeks the patients in both arms will receive a 45 minutes ucSLT once a week
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 48 minutes per day (80% of an hour) and the control group for 12 minutes per day (20% of an hour).
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, 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 12 minutes and the control group for 48 minutes per day.
Active Comparator: Low teleSLT frequency
During four weeks all patients will receive a 45 minutes ucSLT once a week and will do a daily one-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.
Behavioral: ucSLT
The psychological intervention consists of usual care SLT (ucSLT). During four weeks the patients in both arms will receive a 45 minutes ucSLT once a week
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 48 minutes per day (80% of an hour) and the control group for 12 minutes per day (20% of an hour).
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, 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 12 minutes and the control group for 48 minutes per day.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 or over.
  • Diagnosis of stroke, onset of stroke at least 12 months prior to inclusion
  • Diagnosis of aphasia due to stroke, as confirmed by a speech and language therapist.
  • Ability to retrieve 10% - 80% of words on the Boston Naming Test (Kaplan, Goodglass, & Weintraub, 1983).
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228264


Contacts
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

Locations
Switzerland
ARTORG Center for Biomedical Engineering Research Not yet recruiting
Bern, Switzerland, 3008
Contact: Tobias Nef, Prof. Dr.    +41 31 632 74 78    tobias.nef@artorg.unibe.ch   
Sub-Investigator: Stephan Gerber, M.Sc.         
Sub-Investigator: Patric Wyss, M.Sc.         
Center for Neurology and Neurorehabilitation Not yet recruiting
Lucerne, Switzerland, 6000
Contact: Thomas Nyffeler, Prof. Dr.    +41 41 205 56 86    thomas.nyffeler@luks.ch   
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Tabias Nef, Prof. Dr. Gerontechnology and Rehabilitation, ARTORG Centre for Biomedical Engineering Research
  More Information

Publications:
Enderby, P., John, A., & Petheram, B. (2013). Therapy outcome measures for rehabilitation professionals: speech and language therapy, physiotherapy, occupational therapy: John Wiley & Sons.
Kaplan, E., Goodglass, H., & Weintraub, S. (1983). The Boston naming test. 2nd. Philadelphia: Lea & Febiger.

Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03228264     History of Changes
Other Study ID Numbers: 2016-01577
First Submitted: July 12, 2017
First Posted: July 24, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Seizures
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations