AphasiaAPHACOMNCT04070625
Communication Book in Pragmatic Communication in Vascular Aphasics
An observational study of Aphasia and Communication, run by University Hospital, Bordeaux.
Trial summary
This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Communication
- What is being tested?
- Communication book group
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2009to 10 Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the six participating neurological rehabilitation centers, each of which has significant recruitment of aphasic subjects and has a specialized team in the management of language disorders.
Who may be able to join
- Informed consent after information. Information is also given to the person of trust when it exists.
- aphasic subjects admitted to hospital or seen in consultation following a 1st ischemic or hemorrhagic symptomatic vascular accident constituted
- during the first year of onset of aphasia
- adults over 18 years old
- French
- phasic disorder of severe severity expression (overall severity score between 0 and 2 at the diagnostic battery for the assessment of aphasia scale)
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- residual ability to understand clinical assessments and informed consent; information about the objectives and the procedure of the research will also be given to the patient's designated confidant
- motor capacity for comfortable sitting and transfers with help
- affiliation to health insurance
- no deficits in visual perceptual tests (researched using the visual decision of objects and Montreal protocol for the evaluation of visual gnosis), which allows the use of the communication book,
Who cannot join
- refusal or impossibility of consent
- disturbance of vigilance
- insane state
- psychiatric history requiring hospitalization in a specialized environment
- perceptual disturbance, visual agnosia not allowing the use of the image support
- pregnancy or breastfeeding
- administration after the occurrence of stroke of a product for which an effect on the recovery of aphasia has been reported: piracetam, bromocriptine, donepezil, dextroamphetamine (if treatment with these products has been performed, inclusion is possible after a weaning period of 15 days)
- simultaneous inclusion in another therapeutic protocol of language disorders
About this study
Official title: Evaluation of the Effectiveness of a Communication Book in Pragmatic Communication in Vascular Aphasics During the First Year Post-Stroke
This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.
Read the detailed description
Data from the literature have demonstrated the effectiveness of speech therapy in aphasic vascular. In the face of sequelae, particularly in the most serious aphasia, a palliative approach aims to increase the functional effectiveness of communication in everyday life. The communication book has been developed in this perspective, addressing aphasics whose language communication skills are greatly reduced. Early use in this trial is warranted by implantation prior to the onset of potentially deleterious compensatory mechanisms seen in the late-stage aphasic sequelae.
This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.
- Conditions
- Aphasia, Communication
- Being tested
- Communication book group, Control group
- Medical subject headings
- Aphasia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication book groupOther
Communication book
Control groupOther
Simple speech therapy
| Study group | Role | What they receive |
|---|---|---|
| Communication book group | Speech therapy with communication book Receives: Other: Communication book group | |
| Control group | Simple speech therapy Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful tasks in the communication book
Communication book of Gonzales et al, with 6 tasks
Measured: At Day 45 after stroke
Number of successful tasks in the communication book
Communication book of Gonzales et al, with 6 tasks
Measured: At Day 90 after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start17 Feb 2009
- Primary completion10 Feb 2012
- Study completion10 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Alain JOSEPH, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070625
- Sponsor's protocol ID
- CHUBX 2008/10
- Acronym
- APHACOM
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Communication Book in Pragmatic Communication in Vascular Aphasics During the First Year Post-Stroke
- ClinicalTrials.gov ID
- NCT04070625
- Acronym / sponsor ID
- APHACOM / CHUBX 2008/10
- Conditions
- Aphasia, Communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 Feb 2009 (actual)
- Primary completion
- 10 Feb 2012 (actual)
- Study completion
- 10 Feb 2012 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.
Detailed description
Data from the literature have demonstrated the effectiveness of speech therapy in aphasic vascular. In the face of sequelae, particularly in the most serious aphasia, a palliative approach aims to increase the functional effectiveness of communication in everyday life. The communication book has been developed in this perspective, addressing aphasics whose language communication skills are greatly reduced. Early use in this trial is warranted by implantation prior to the onset of potentially deleterious compensatory mechanisms seen in the late-stage aphasic sequelae.
This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication book group | – | Other: Communication book groupSpeech therapy with communication book |
| Control group | – | Other: Control groupSimple speech therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the six participating neurological rehabilitation centers, each of which has significant recruitment of aphasic subjects and has a specialized team in the management of language disorders.
Key inclusion criteria (10 listed)
- Informed consent after information. Information is also given to the person of trust when it exists.
- aphasic subjects admitted to hospital or seen in consultation following a 1st ischemic or hemorrhagic symptomatic vascular accident constituted
- during the first year of onset of aphasia
- adults over 18 years old
- French
Key exclusion criteria (8 listed)
- refusal or impossibility of consent
- disturbance of vigilance
- insane state
- psychiatric history requiring hospitalization in a specialized environment
- perceptual disturbance, visual agnosia not allowing the use of the image support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication book groupCommunication book | Other | Communication book group |
| Control groupSimple speech therapy | Other | Control group |
Primary outcome
Number of successful tasks in the communication book
Time frame: At Day 45 after stroke
Communication book of Gonzales et al, with 6 tasks
Number of successful tasks in the communication book
Time frame: At Day 90 after stroke
Communication book of Gonzales et al, with 6 tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Alain JOSEPH, Pr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Aphasia and Communication, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful tasks in the communication book (time frame: At Day 45 after stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.