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Outcome Measures

Primary Outcomes (2)

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.
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.
Changes in score at six months

Secondary Outcomes (4)

General Health Questionnaire (GQH-12)
Changes in score at six months
Stroke and aphasia Quality of Life Scale (SAQOL-39)
Changes in score at six months
Western Aphasia Battery Revised (WAB-R)
Changes in score at six months
Stroke Aphasic Depression Questionnaire (SADQ10)
Changes in score at six months

Study Arms (2)

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.

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.

Other: Language and functional communication therapy

Interventions

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.

Group 1: first to receive therapyGroup 2: second to receive therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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).

Related Publications (1)

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.

PMID: 34991688DERIVED

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

A psychologist blinded to the patient´s clinical characteristics and study groups performs the outcome questionnaires three times for each patient during the study period.

Purpose

TREATMENT

Intervention Model

CROSSOVER

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group 1: first to receive therapy

Group 2: second to receive therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group 1: first to receive therapy

Group 2: second to receive therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations