Adaptation of Melodic Intonation Therapy to Spanish

NCT ID: NCT03433495

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2016-07-31

Brief Summary

This study was conducted in three phases:

The first phase involved creation of a Spanish adaptation of the Melodic Intonation therapy; the second phase consisted of a pilot non-randomized intervention study to analyse its feasibility for use with 4 Spanish patients with poststroke nonfluent aphasia; the third phase consisted of a pilot randomised, crossover, intervention pilot trial in a different set of patients with poststroke nonfluent aphasia (N=20)

Conditions

Post Stroke Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Melodic Intonation Therapy

The duration of therapy was 12 sessions performed over a 6-week period. Each session lasted 30 minutes. They were performed individually by a speech-experienced therapist previously trained in Melodic Intonation Therapy.

Group Type: ACTIVE_COMPARATOR

Melodic Intonation Therapy

Intervention Type: OTHER

Waiting list

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Melodic Intonation Therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients diagnosed with nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere who fulfilled the following criteria:

• The time elapsed since the stroke exceeded 6 months.
• Patient had received a standard program of conventional speech therapy after stroke.
• Persistent nonfluent aphasia with the following characteristics:

• Severely restricted language, which might be limited to meaningless stereotypy; unlike that observed in verbal tasks, the patient might produce some real and relevant words when singing familiar songs.
• Poor repetition, even for single words.
• Moderately preserved language comprehension.
• The nonstereotyped language was produced with a slurring of speech.
• The total score for the repetition did not exceed the 70th percentile in the Boston Diagnostic Aphasia Examination. The score was obtained from the average score in three areas: repetition of words and repetition of phrases; listening comprehension exceeding the 15th percentile of Boston Diagnostic Aphasia Examination; and from the average score obtained in three areas: word comprehension, commands and complex ideational material.
• The patient was motivated, emotionally stable and had good attention.
• Signed informed consent was provided.

Exclusion Criteria

• patients with a history of a previous stroke other than the index event or with any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up in the study
• patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
• use of psychotropic drugs that interfere with patient evaluation.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PI-894

Identifier Type: -

Identifier Source: org_study_id