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Tablet-based Aphasia Therapy in the Acute Phase After Stroke

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: NCT03679637
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Neurologie, University Hospital, Ghent

Brief Summary:
As aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. However, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. Although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. The investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. The researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.

Condition or disease Intervention/treatment Phase
Aphasia Stroke, Acute Behavioral: Tablet-based aphasia therapy Not Applicable

Detailed Description:
The study is a prospective study, with each participant undergoing testing approximately within three days after inclusion in the study (immediately prior to tablet-based aphasia therapy). Based on the results of diagnostic testing (standard of care in the acute phase), therapy will be tailored for each individual. After two short training sessions, patients will independently practice with the app during hospitalisation, guided by a user-friendly instruction sheet. Patients will be encouraged to practice as much as possible, with a minimum of 30 minutes per day. Exercises will be selected by the speech-language therapist based on diagnostic results and will be adjusted for difficulty and type of exercise during treatment based on performance rates. the aim of the study is to investigate the feasibility, usability and acceptability of a tablet-based aphasia therapy in patients with aphasia in the acute phase following stroke.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Intervention group
Each participant will receive a tablet-based aphasia therapy
Behavioral: Tablet-based aphasia therapy
patients will independently practice with a speech app during hospitalisation




Primary Outcome Measures :
  1. Feasibility of a tablet-based aphasia therapy via the recruitment rate [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
    Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll

  2. Feasibility of a tablet-based aphasia therapy via the retention rate [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
    Retention rate: number of patients continuing to use the mobile tablet until the time of discharge + notation of reasons why patients did not continue practicing

  3. Feasibility of a tablet-based aphasia therapy via the adherence rate, [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
    Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time

  4. Feasibility of a tablet-based aphasia therapy via protocol deviations [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
    Notation of any protocol deviations

  5. Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire, [ Time Frame: date of hospital discharge, an average of 1 week ]
    Self-prepared usability questionnaire: patients will need to fill in a 5 question survey (5-point Likert scale) measuring the usability of a tablet-based therapy. Minimum score is 1 (= totally not agree), maximum score is 5 (= totally agree)

  6. Usability of a tablet-based aphasia therapy via an observational checklist [ Time Frame: date of hospital discharge, assessed up to 20 weeks ]
    Self-prepared observational checklist: patients will be observed during a therapy session. Different sub-tasks will be scored for independency on a 3-point scale. Minimum score is 1 (completely dependent), maximum score is 3 (= completely independent)

  7. Usability of a tablet-based aphasia therapy via within-task improvements of the app [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
    Notation of exercises performed with the app

  8. Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction [ Time Frame: date of hospital discharge, an average of 1 week ]
    Vertical visual anologue scale (VAS) for satisfaction: patients have to indicate their general level of satisfaction post-intervention on a vertical VAS-scale. Minimum score is 0 (= not satisfied), maximum score is 100 (= very satisfied)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Diagnosed with aphasia after an ischemic or hemorrhagic stroke
  • Maximum 2 weeks post-stroke
  • Minimum 18 years old
  • A minimum proficient language level of Dutch
  • Imaging (CT or MRI) prior to inclusion
  • Signed informed consent

Exclusion Criteria:

  • Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy

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): NCT03679637


Contacts
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Contact: Veerle De Herdt +32(0)9 332 64 81 veerle.deherdt@ugent.be

Locations
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Belgium
University Hospital, department of neurology Recruiting
Gent, Belgium, 9000
Contact: Veerle De Herdt    +32(0)9 332 64 81    veerle.deherdt@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Veerle De Herdt University Ghent

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Responsible Party: Neurologie, Principal Investigator, clinical professor Veerle De Herdt, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03679637    
Other Study ID Numbers: EC/2018/1006
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms