- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545894
An Evaluation of a New Nonverbal Treatment for Global Aphasia
An Investigation Into the Effect of a Novel, Non Verbal, Cognitive Treatment on Functional Communication in Global Aphasia
People with global aphasia (PwGA) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).A proportion of PwGA will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. There is a suggestion in the literature that this is because of co-occurring cognitive deficits. The consequence is that these clients are unable to reliably communicate even their basic needs.This is commonly known as having no functional communication abilities. Such PwGA tend not to respond to standard speech and language therapy interventions.
This research will investigate the effect of a new cognitive intervention designed to improve basic functional communication abilities. The treatment will be nonverbal and involve computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to eight participants will take part. All their sessions will take place in their own home. For some this may be a care home. They will first complete a diagnostic communication assessment in order for baseline abilities to be established. Further formal language and cognitive assessments will be conducted over a period of 6 weeks. A relative/friend will complete a questionnaires about mood/communication. The PwGA will also be videoed interacting with the research student e.g. looking at a magazine, completing a jigsaw, answering questions and making choices non-verbally.
The participants then receive the new intervention 3 times a week for 6 consecutive weeks. All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks using the same assessments as prior to the intervention. The questionnaire with their relative/friend and videoed activity session will also be repeated. After a twelve week break the participant will be videoed interacting with the research student complete some of the assessments again and their relative will re-complete the questionnaires.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, WC1N
- University College London, Research Dept of Language and Cognition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have global aphasia as diagnosed by an SLT
- have little or no verbal output
- inconsistent single word comprehension
- little or no ability to read or write
- little or no ability to use alternative modes of communication
- Little or no ability to make choices in function
- no diagnosis/history of a progressive neurological condition
- no diagnosis of hearing loss
- no diagnosis/history of a mental health condition
- English as a first language
Exclusion Criteria:
- has another form of aphasia
- is able to consistently express basic needs non-verbally or verbally.
- is able to participate in communicative interaction with a familiar other
- has a history of a progressive neurological condition
- has hearing loss
- has a diagnosis/history of a mental health condition
- does not have English as a first language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: BASELINE TESTING
Language and cognitive assessments conducted
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Experimental: Treatment
Intervention given: visual tracking pressing a button every time a picture is seen on the screen
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The tasks are:
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No Intervention: Post intervention
Repeated testing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
American Speech and Hearing Association -Functional Assessment of Communication
Time Frame: 27 weeks
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Questionnaire completed by friend/relative
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27 weeks
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Constructed Interaction Task
Time Frame: 27 weeks
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video recorded interaction
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27 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aphasia Screening Test
Time Frame: 14 weeks
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Language assessment
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14 weeks
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Mood Screen
Time Frame: 27 weeks
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depression screening tool
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27 weeks
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Pyramids and Palm Trees Test
Time Frame: 27 weeks
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pictorial semantic assessment
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27 weeks
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Wisconsin Card Sorting Test
Time Frame: 14 weeks
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cognitive assessment
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14 weeks
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Butt Non verbal reasoning test
Time Frame: 27 weeks
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cognitive assessment
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27 weeks
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Western Aphasia Battery cognitive sub test
Time Frame: 14 weeks
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cognitive assessment
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14 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suzanne Beeke, PhD, UCL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/0581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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