Aphasia, Post-IctalNCT04289493
DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke
A study testing Language and functional communication therapy in people with Aphasia, Post-Ictal, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from television series that represent daily situations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphasia, Post-Ictal
- What is being tested?
- Language and functional communication therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2020to 27 Sep 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere.
- the patient should have received a standard program of conventional speech therapy after stroke, remaining with aphasia with the following characteristics: severely restricted language, poor repetition (even for single words), not exceeding the 70th percentile in the Boston Diagnostic Aphasia Examination (BDAE) for repetition. Moderately preserved language comprehension: listening comprehension exceeding the 15th percentile of BDAE (average score obtained in three areas: word comprehension, commands and complex ideational material).
- Signed informed consent.
Who cannot join
- Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up.
- Participation in any therapeutic trial evaluating poststroke recovery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke (DULCINEA). A Feasibility Cross-over Pilot-trial
The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from television series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia. Patients will be treated individually in 40-minute sessions twice a week for 8 weeks. In each session, a speech therapist and an actor will select the clips with muted words or sentences that have been detected as functionally meaningful for each patient. Outcomes will be assessed as significant differences in two aphasia tests.
Read the detailed description
The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from TV series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia from the departments of Neurology and Rehabilitation from La Paz University Hospital and also from the "Afasia Activa" association. After meeting all inclusion and none of the exclusion criteria and signing informed consent, patients will be randomised (1:1) in two different treatment groups. The first group will receive therapy within the first 3 months of their inclusion with a subsequent period of another 3 months without therapy (thus, serving as group 2 controls). Group 2 will initiate therapy after 3 months since their inclusion (serving as group 1 controls during the first 3 months). Therapy consists of 17 sessions performed in a eight week period (1 baseline session and 16 dubbing sessions), each lasting 40 minutes, in which the patient will be asked to dubb words or sentences previously selected and considered as functionally meaningful for them. These words will be chosen through an online survey performed by a representative group of aphasic patients and the study patients´own relatives in the baseline treatment session. Outcomes will be assessed as significant differences in two aphasia tests (CAL questionnaire and the BDAE).
- Conditions
- Aphasia, Post-Ictal
- Being tested
- Language and functional communication therapy
- Keywords
- Rehabilitation, Word dubbing, Functional communication
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language and functional communication therapyOther
17 therapy sessions in which the patients will be asked to dubb words or sentences from television series previously considered functionally meaningful for them.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: first to receive therapy | Experimental | 27 patients that will receive study specific speech therapy in the first 3 months since study inclusion. From months 3-6 they will be group 2 controls. Receives: Other: Language and functional communication therapy |
| Group 2: second to receive therapy | Experimental | 27 patients that will receive study specific speech therapy during months 3-6 since study inclusion. During the first 3 months of the study period, they will be group 1 controls. Receives: Other: Language and functional communication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communicative Activity Log (CAL) questionnaire
Questionnaire that evaluates quantity and quality of aphasic patient communication, with 18 different questions in each item. Each question belonging to these two items is answered as a 6 point scale, where 0 is the worst and 5 is the best score.
Measured: Changes in score at six months
Boston Diagnostic Aphasia Examination (BDAE)
Neuropsycological battery that evaluates language skills based on perceptual modalities (auditory, visual, and gestural), processing functions (comprehension, analysis, problem-solving), and response modalities (writing, articulation, and manipulation). There are five subtests which include: conversational and expository speech, auditory comprehension, oral expression, reading, and writing. Its results can be used to classify patient's language profiles into one of the localization based classifications of aphasia, and it also provides a severity rating.
Measured: Changes in score at six months
Secondary outcomes (4)
General Health Questionnaire (GQH-12)
The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. It comprises 12 questions, each one with a four point scale answer.
Measured: Changes in score at six months
Stroke and aphasia Quality of Life Scale (SAQOL-39)
SAQOL-39 is an interview-administered self-report scale that comprises the 49 items of the SS-QOL (modified to be communicatively accessible to people with aphasia) and 4 additional items that measure speech comprehension, difficulties with decision-making and and impact of language problems on family and social life. Questions are answered with a five point scale.
Measured: Changes in score at six months
Western Aphasia Battery Revised (WAB-R)
This neuropsycological test assesses linguistic and non-linguistic skills comprised of 8 subtest (32 short tasks). It identifies aphasia and classifies the type and severity of aphasia disorders.
Measured: Changes in score at six months
Stroke Aphasic Depression Questionnaire (SADQ10)
This is a brief questionnaire with 10 items testing depression symptoms within the last week in aphasic patients. Each item scores in a four point scale.
Measured: Changes in score at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start18 Dec 2020
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aphasia, Post-IctalStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two groups with 27 patients in each one. Group 1 starts therapy in the first 3 months since study inclusion and from months 3-6 is group 2 control. Group 2 starts language therapy from months 3-6, serving previously as group 1 control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pontificia Comillas, Asociación Afasia Activa, La Caixa Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289493
- Sponsor's protocol ID
- DULCINEA
- Status last verified
- Oct 2024
- First submitted
- 20 Feb 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuentes B, de la Fuente-Gomez L, Sempere-Iborra C, Delgado-Fernandez C, Tarifa-Rodriguez A, Alonso de Lecinana M, de Celis-Ruiz E, Gutierrez-Zuniga R, Lopez-Tappero J, Martin Alonso M, Pastor-Yborra S, Rigual R, Ruiz-Ares G, Rodriguez-Pardo J, Virues-Ortega J, Borobia AM, Blanco P, Bueno-Guerra N. DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial. Trials. 2022 Jan 6;23(1):21. doi: 10.1186/s13063-021-05956-5.
PubMed 34991688
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke (DULCINEA). A Feasibility Cross-over Pilot-trial
- ClinicalTrials.gov ID
- NCT04289493
- Acronym / sponsor ID
- DULCINEA
- Conditions
- Aphasia, Post-Ictal
- Keywords
- Rehabilitation, Word dubbing, Functional communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Universidad Pontificia Comillas, Asociación Afasia Activa, La Caixa Foundation
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 28 Feb 2020 (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.
The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from television series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia. Patients will be treated individually in 40-minute sessions twice a week for 8 weeks. In each session, a speech therapist and an actor will select the clips with muted words or sentences that have been detected as functionally meaningful for each patient. Outcomes will be assessed as significant differences in two aphasia tests.
Detailed description
The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from TV series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia from the departments of Neurology and Rehabilitation from La Paz University Hospital and also from the "Afasia Activa" association. After meeting all inclusion and none of the exclusion criteria and signing informed consent, patients will be randomised (1:1) in two different treatment groups. The first group will receive therapy within the first 3 months of their inclusion with a subsequent period of another 3 months without therapy (thus, serving as group 2 controls). Group 2 will initiate therapy after 3 months since their inclusion (serving as group 1 controls during the first 3 months). Therapy consists of 17 sessions performed in a eight week period (1 baseline session and 16 dubbing sessions), each lasting 40 minutes, in which the patient will be asked to dubb words or sentences previously selected and considered as functionally meaningful for them. These words will be chosen through an online survey performed by a representative group of aphasic patients and the study patients´own relatives in the baseline treatment session. Outcomes will be assessed as significant differences in two aphasia tests (CAL questionnaire and the BDAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with 27 patients in each one. Group 1 starts therapy in the first 3 months since study inclusion and from months 3-6 is group 2 control. Group 2 starts language therapy from months 3-6, serving previously as group 1 control.
| Arm | Type | Receives |
|---|---|---|
| Group 1: first to receive therapy | Experimental | Other: Language and functional communication therapy27 patients that will receive study specific speech therapy in the first 3 months since study inclusion. From months 3-6 they will be group 2 controls. |
| Group 2: second to receive therapy | Experimental | Other: Language and functional communication therapy27 patients that will receive study specific speech therapy during months 3-6 since study inclusion. During the first 3 months of the study period, they will be group 1 controls. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere.
- the patient should have received a standard program of conventional speech therapy after stroke, remaining with aphasia with the following characteristics: severely restricted language, poor repetition (even for single words), not exceeding the 70th percentile in the Boston Diagnostic Aphasia Examination (BDAE) for repetition. Moderately preserved language comprehension: listening comprehension exceeding the 15th percentile of BDAE (average score obtained in three areas: word comprehension, commands and complex ideational material).
- Signed informed consent.
Key exclusion criteria (2 listed)
- Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up.
- Participation in any therapeutic trial evaluating poststroke recovery.
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 |
|---|---|---|
| Language and functional communication therapy17 therapy sessions in which the patients will be asked to dubb words or sentences from television series previously considered functionally meaningful for them. | Other | Group 1: first to receive therapy, Group 2: second to receive therapy |
Primary outcome
Communicative Activity Log (CAL) questionnaire
Time frame: Changes in score at six months
Questionnaire that evaluates quantity and quality of aphasic patient communication, with 18 different questions in each item. Each question belonging to these two items is answered as a 6 point scale, where 0 is the worst and 5 is the best score.
Boston Diagnostic Aphasia Examination (BDAE)
Time frame: Changes in score at six months
Neuropsycological battery that evaluates language skills based on perceptual modalities (auditory, visual, and gestural), processing functions (comprehension, analysis, problem-solving), and response modalities (writing, articulation, and manipulation). There are five subtests which include: conversational and expository speech, auditory comprehension, oral expression, reading, and writing. Its results can be used to classify patient's language profiles into one of the localization based classifications of aphasia, and it also provides a severity rating.
4 secondary outcomes
General Health Questionnaire (GQH-12)
Time frame: Changes in score at six months
Stroke and aphasia Quality of Life Scale (SAQOL-39)
Time frame: Changes in score at six months
Western Aphasia Battery Revised (WAB-R)
Time frame: Changes in score at six months
Stroke Aphasic Depression Questionnaire (SADQ10)
Time frame: Changes in score at six months
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 15 Oct 2024.
- Derived from this study: PubMed 34991688Fuentes B, de la Fuente-Gomez L, Sempere-Iborra C, Delgado-Fernandez C, Tarifa-Rodriguez A, Alonso de Lecinana M, de Celis-Ruiz E, Gutierrez-Zuniga R, Lopez-Tappero J, Martin Alonso M, Pastor-Yborra S, Rigual R, Ruiz-Ares G, Rodriguez-Pardo J, Virues-Ortega J, Borobia AM, Blanco P, Bueno-Guerra N. DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial. Trials. 2022 Jan 6;23(1):21. doi: 10.1186/s13063-021-05956-5.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language and functional communication therapy in people with Aphasia, Post-Ictal, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 3 inclusion and 2 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 15 Oct 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 Spain. 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?
Communicative Activity Log (CAL) questionnaire (time frame: Changes in score at six months). 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?
On the ClinicalTrials.gov record for NCT04289493, which also lists 1 linked publication.
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 15 Oct 2024.