- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05101408
Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia (ETAT PSA)
April 11, 2022 updated by: University Hospital, Montpellier
Combining Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia : a Single Case Experimental Design -SCED Preliminary Study
Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature.
If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate.
The influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.The aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France, 34295
- UHMontpellier
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Person with post-stroke aphasia at the chronic stage, receiving SLT rehabilitation
Description
Inclusion criteria:
- 18 < age > 80 years
- adult person with chronic post-stroke aphasia (> 6 months postonset)
- receiving SLT rehabilitation 3 times a Week
Exclusion criteria:
- presence of apraxia of speech
- major impairment of comprehension
- history of other neurological or psychiatric disease
Exclusion criteria:
- presence of apraxia of speech
- presence of major impairment of comprehension
- presence of history of other neurological or psychiatric disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of individual naming scores
Time Frame: 2 days
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Evolution of individual naming scores during baseline and treatment phases Participants are asked to name pictures from a personal naming task constituted of 100 black and white pictures and scores are expressed as percent of correct responses (min 0, max 100): higher percents meaning a better outcome.
A visual analysis of the evolution of these scores along the course of the treatment will be conducted.
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2 days
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Comparison of discourse
Time Frame: 2 days
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Comparison of discourse scores before and after the treatment For each participant, four different samples of discourse are elicited before and after the treatment (picture description, personal narrative, book supported narrative, procedural information).
The mean number of correct words per minute is then computed for each participant, and compared between the two time points, higher scores meaning a better outcome.
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2 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of executive scores
Time Frame: 2 days
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Comparison of executive scores before and after the treatment Executive scores are computed before and after treatment for each participant, from the Modified Card Sorting Test (Nelson, 1976), in which higher number of categories achieved means a better outcome, and from a verbal fluency task in which higher number of words produced in 2 minutes means a better outcome
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2 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sylvie Moritz-Gasser, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
October 19, 2021
First Posted (Actual)
November 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 11, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL21_0597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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