Adaptation of Melodic Intonation Therapy to Spanish

Post Stroke Aphasia Clinical Trial

Official title:

Adaptation of Melodic Intonation Therapy to Spanish: a Feasibility and Validation Pilot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433495
• Other study ID #: PI-894
• Status: Completed
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 13, 2018
• Start date: February 2010
• Est. completion date: July 2016

Study information

• Verified date: February 2018
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Post Stroke Aphasia

Intervention

Other:
• Melodic Intonation Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communicative Activity Log questionnaire		6 weeks after the end of therapy
Primary	Boston Diagnostic Aphasia Examination		6 weeks after the end of therapy