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Completed

NCT Number: NCT03433495

Adaptation of Melodic Intonation Therapy to Spanish

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)

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melodic Intonation Therapy

Other

Primary outcomes

  1. Communicative Activity Log questionnaire

    Time frame: 6 weeks after the end of therapy

  2. Boston Diagnostic Aphasia Examination

    Time frame: 6 weeks after the end of therapy

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 14, 2018
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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