Adaptation of Melodic Intonation Therapy to Spanish

NCT03433495 | Completed

• 1 other identifier: PI-894
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

stroke; aphasia; melodic intonation therapy

Outcome Measures

Primary Outcomes (2)

• Communicative Activity Log questionnaire

  6 weeks after the end of therapy

• Boston Diagnostic Aphasia Examination

  6 weeks after the end of therapy

Study Arms (2)

Melodic Intonation Therapy

ACTIVE COMPARATOR

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.

Other: Melodic Intonation Therapy

Waiting list

NO INTERVENTION

No intervention

Interventions

Melodic Intonation Therapy OTHER

Melodic Intonation Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A neuropsychologist blinded to the patients' clinical characteristics and the group to whom the patient was allocated evaluated outcome variables.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: February 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share