Aphasia, AcquiredORACLENCT03287544
Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke
A study testing Combined rehabilitation and Linguistic rehabilitation in people with Aphasia, Acquired, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Acquired
- What is being tested?
- Combined rehabilitation and Linguistic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 27 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- First stroke
- Patient registered at the social security system
- French as usual language
- Aphasia severity score measured by the Boston Diagnostic Aphasia Examination (BDAE) scale ≥ 1 and ≤ 4
- Consent signed by the patient or if not, by the caregiver
Who cannot join
- Cognitive impairment before the onset (IQCode > 3.4)
- Alcohol or drug addiction
- Untreated psychiatric disease,
- Uncorrected sensory impairment
- Evolutive pathology
- Adults protected by Law
- Participation to another research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study
Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.
Read the detailed description
Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known standard treatment of aphasia after stroke although it is based on weak scientific evidence. To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well as personalized treatment. Usually these patients receive in acute phase a linguistic training focused on the linguistic impairment. This approach is based on the cerebral plasticity postulate. However the superiority of this practice compared to other methods has never been shown. Moreover the benefit of the combination gathering linguistic treatment with communication treatment has to our knowledge never been studied.
In the present study investigators propose to compare the effect of a combined linguistic/communication rehabilitation versus a linguistic treatment. To do so, investigators will recruit patients with aphasia after a first stroke, in the acute phase. After a allocation to the " combined " and " linguistic " groups, all the patients will have a comprehensive language and neuropsychological assessment before and after 3 months of rehabilitation, and finally 6 months after the onset.
The "linguistic" group will have a rehabilitation only focused on linguistic processes whereas the "combined" group will have a linguistic training as well as communication training. The therapy will be personalized and the therapists will exclusively use standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated activities.
- Conditions
- Aphasia, Acquired
- Being tested
- Combined rehabilitation, Linguistic rehabilitation
- Keywords
- Aphasia, Rehabilitation, Communication, Linguistics
- Medical subject headings
- Aphasia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined rehabilitationOther
Linguistic training as well as communication training.
Linguistic rehabilitationOther
Rehabilitation only focused on linguistic processes.
| Study group | Role | What they receive |
|---|---|---|
| Combined rehabilitation | Experimental | Linguistic training as well as communication training. Receives: Other: Combined rehabilitation |
| Linguistic rehabilitation | Active comparator | Rehabilitation only focused on linguistic processes. Receives: Other: Linguistic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the communication performance.
Assessed by the Lillois communication test
Measured: Month 3
Secondary outcomes (3)
Assessment of the communication performance.
Assessed by the Lillois communication test
Measured: Month 6
Assessment of the linguistic performance.
Assessed by the "Score at understanding task".
Measured: Month 3; Month 6
Assessment of the quality of life.
Assessed by the "Score at a specific quality of life scale ".
Measured: Month 3; Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Mar 2018
- Primary completion30 Jun 2022
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are two arms in the protocol: one experimental arm corresponding to the "combined" rehabilitation (linguistic/communication) compared with another arm corresponding to the "linguistic" rehabilitation. All included patients, after allocation based on aphasia severity to the " combined " and " linguistic " groups, will have a first evaluation (E1: language, neurologic and neuropsychological exams) within 7 days after the onset. Then after a 3 months rehabilitation period they will be assessed (E2: language, neurologic and neuropsychological exams). At 6 months after the onset they will finally have the last assessment (E3: language, neurologic and neuropsychological exams).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lola Danet, Phd, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287544
- Sponsor's protocol ID
- RC31/16/0018
- Other IDs
- 2017-A02163-50
- Acronym
- ORACLE
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120. doi: 10.1007/s40141-014-0050-5.
PubMed 25133085Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
PubMed 12649521Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.
PubMed 24904925Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
PubMed 2594878Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99. doi: 10.3109/13682828909019892.
PubMed 2627547Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.
PubMed 18720316Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82. doi: 10.3109/13682828609018544. No abstract available.
PubMed 3730272
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study
- ClinicalTrials.gov ID
- NCT03287544
- Acronym / sponsor ID
- ORACLE / RC31/16/0018
- Conditions
- Aphasia, Acquired
- Keywords
- Aphasia, Rehabilitation, Communication, Linguistics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 19 Sep 2017 (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.
Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.
Detailed description
Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known standard treatment of aphasia after stroke although it is based on weak scientific evidence. To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well as personalized treatment. Usually these patients receive in acute phase a linguistic training focused on the linguistic impairment. This approach is based on the cerebral plasticity postulate. However the superiority of this practice compared to other methods has never been shown. Moreover the benefit of the combination gathering linguistic treatment with communication treatment has to our knowledge never been studied.
In the present study investigators propose to compare the effect of a combined linguistic/communication rehabilitation versus a linguistic treatment. To do so, investigators will recruit patients with aphasia after a first stroke, in the acute phase. After a allocation to the " combined " and " linguistic " groups, all the patients will have a comprehensive language and neuropsychological assessment before and after 3 months of rehabilitation, and finally 6 months after the onset.
The "linguistic" group will have a rehabilitation only focused on linguistic processes whereas the "combined" group will have a linguistic training as well as communication training. The therapy will be personalized and the therapists will exclusively use standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two arms in the protocol: one experimental arm corresponding to the "combined" rehabilitation (linguistic/communication) compared with another arm corresponding to the "linguistic" rehabilitation. All included patients, after allocation based on aphasia severity to the " combined " and " linguistic " groups, will have a first evaluation (E1: language, neurologic and neuropsychological exams) within 7 days after the onset. Then after a 3 months rehabilitation period they will be assessed (E2: language, neurologic and neuropsychological exams). At 6 months after the onset they will finally have the last assessment (E3: language, neurologic and neuropsychological exams).
| Arm | Type | Receives |
|---|---|---|
| Combined rehabilitation | Experimental | Other: Combined rehabilitationLinguistic training as well as communication training. |
| Linguistic rehabilitation | Active comparator | Other: Linguistic rehabilitationRehabilitation only focused on linguistic processes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First stroke
- Patient registered at the social security system
- French as usual language
- Aphasia severity score measured by the Boston Diagnostic Aphasia Examination (BDAE) scale ≥ 1 and ≤ 4
- Consent signed by the patient or if not, by the caregiver
Key exclusion criteria (7 listed)
- Cognitive impairment before the onset (IQCode > 3.4)
- Alcohol or drug addiction
- Untreated psychiatric disease,
- Uncorrected sensory impairment
- Evolutive pathology
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 |
|---|---|---|
| Combined rehabilitationLinguistic training as well as communication training. | Other | Combined rehabilitation |
| Linguistic rehabilitationRehabilitation only focused on linguistic processes. | Other | Linguistic rehabilitation |
Primary outcome
Assessment of the communication performance.
Time frame: Month 3
Assessed by the Lillois communication test
3 secondary outcomes
Assessment of the communication performance.
Time frame: Month 6
Assessment of the linguistic performance.
Time frame: Month 3; Month 6
Assessment of the quality of life.
Time frame: Month 3; Month 6
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 3 Jan 2024.
- Background: PubMed 25133085Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120. doi: 10.1007/s40141-014-0050-5.
- Background: PubMed 12649521Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
- Background: PubMed 24904925Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.
- Background: PubMed 2594878Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
- Background: PubMed 2627547Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99. doi: 10.3109/13682828909019892.
- Background: PubMed 18720316Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.
- Background: PubMed 3730272Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82. doi: 10.3109/13682828609018544. No abstract available.
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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.
Lola Danet, Phd principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined rehabilitation and Linguistic rehabilitation in people with Aphasia, Acquired, run by University Hospital, Toulouse at 1 site in France.
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 5 inclusion and 7 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of the communication performance. (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287544, which also lists 7 linked publications.
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 3 Jan 2024.