Back to resultsTablet-based Aphasia Therapy in the Chronic Phase
Primary Purpose
Aphasia, Stroke
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
speech app
brain games
aphasia therapy
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia
Eligibility Criteria
Inclusion Criteria:
- diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic stroke
- inclusion starting from 6 months post-stroke
- age 18 - 85 years
- being right-handed (according to the questionnaire for handedness, Van Strien)
- mother tongue: Dutch
- imaging (CT or MRI) prior to inclusion
- signed informed consent
Exclusion Criteria:
- history of a previous stroke with persistent (> 24 hours) language symptoms
- history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders
- serious non-linguistic, cognitive disorders (as documented in the patients' medical history)
- inability to perform tablet-based tasks (based on a short training session)
- excessive use of alcohol or drugs
Sites / Locations
- University Hospital, department of neurology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
aphasia therapy + speech app
aphasia therapy + brain games
aphasia therapy
Arm Description
3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app
3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games)
3 hours per week of conventional aphasia therapy during 3 weeks
Outcomes
Primary Outcome Measures
Boston Naming Test (BNT)
Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty
Secondary Outcome Measures
Spontaneous speech of the Aachen Aphasia Test (AAT)
spontaneous speech is elicited and scored during a semi-standardized interview
Quality of life (SAQOL-39-Nl)
a questionnaire investigating the health-related quality of life of patients following stroke
Usability questionnaire
a self-prepared 5 point-Likert Scale concerning the usability of the app
Full Information
NCT ID
NCT03622411
First Posted
August 6, 2018
Last Updated
January 6, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT03622411
Brief Title
Tablet-based Aphasia Therapy in the Chronic Phase
Official Title
The Effect of a Tablet-based Aphasia Therapy in the Chronic Phase After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits. There is evidence that intensive aphasia therapy is effective for language recovery, even in the chronic phase post-stroke. However, as many patients are left with residual language disorders and intensive aphasia rehabilitation is difficult to achieve, the investigators are exploring tablet-based therapies to further facilitate language recovery in a cost-effective manner.
Detailed Description
This study will investigate the clinical effects of intensive tablet-based aphasia therapy as an add-on to conventional aphasia therapy (= high intensive) compared to conventional aphasia therapy (either alone, or in combination with recreational tablet use (= low intensive) in patients with aphasia following stroke, as measured by specific linguistic tests, within task improvements, functional communication and quality of life.
Furthermore, the investigators want to learn more about the recovery of specific underlying language processes via event-related potentials (ERPs). At last, the investigators aim to explore whether patients with aphasia are satisfied with a tablet-based aphasia therapy, whether the app is user-friendly and which barriers the participants might have encountered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aphasia therapy + speech app
Arm Type
Experimental
Arm Description
3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app
Arm Title
aphasia therapy + brain games
Arm Type
Active Comparator
Arm Description
3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games)
Arm Title
aphasia therapy
Arm Type
Active Comparator
Arm Description
3 hours per week of conventional aphasia therapy during 3 weeks
Intervention Type
Device
Intervention Name(s)
speech app
Intervention Description
language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app
Intervention Type
Device
Intervention Name(s)
brain games
Intervention Description
language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games
Intervention Type
Behavioral
Intervention Name(s)
aphasia therapy
Intervention Description
language exercises provided by the speech therapist in hospital
Primary Outcome Measure Information:
Title
Boston Naming Test (BNT)
Description
Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Spontaneous speech of the Aachen Aphasia Test (AAT)
Description
spontaneous speech is elicited and scored during a semi-standardized interview
Time Frame
4 months
Title
Quality of life (SAQOL-39-Nl)
Description
a questionnaire investigating the health-related quality of life of patients following stroke
Time Frame
4 months
Title
Usability questionnaire
Description
a self-prepared 5 point-Likert Scale concerning the usability of the app
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic stroke
inclusion starting from 6 months post-stroke
age 18 - 85 years
being right-handed (according to the questionnaire for handedness, Van Strien)
mother tongue: Dutch
imaging (CT or MRI) prior to inclusion
signed informed consent
Exclusion Criteria:
history of a previous stroke with persistent (> 24 hours) language symptoms
history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders
serious non-linguistic, cognitive disorders (as documented in the patients' medical history)
inability to perform tablet-based tasks (based on a short training session)
excessive use of alcohol or drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veerle De Herdt
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, department of neurology
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tablet-based Aphasia Therapy in the Chronic Phase
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