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Adaptation of Melodic Intonation Therapy to Spanish

Primary Purpose

Post Stroke Aphasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Melodic Intonation Therapy
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Stroke Aphasia focused on measuring stroke, aphasia, melodic intonation therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Melodic Intonation Therapy

    Waiting list

    Arm Description

    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.

    No intervention

    Outcomes

    Primary Outcome Measures

    Communicative Activity Log questionnaire
    Boston Diagnostic Aphasia Examination

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2018
    Last Updated
    February 13, 2018
    Sponsor
    Instituto de Investigación Hospital Universitario La Paz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03433495
    Brief Title
    Adaptation of Melodic Intonation Therapy to Spanish
    Official Title
    Adaptation of Melodic Intonation Therapy to Spanish: a Feasibility and Validation Pilot Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (Actual)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Investigación Hospital Universitario La Paz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Stroke Aphasia
    Keywords
    stroke, aphasia, melodic intonation therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Masking Description
    A neuropsychologist blinded to the patients' clinical characteristics and the group to whom the patient was allocated evaluated outcome variables.
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Melodic Intonation Therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Waiting list
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Other
    Intervention Name(s)
    Melodic Intonation Therapy
    Primary Outcome Measure Information:
    Title
    Communicative Activity Log questionnaire
    Time Frame
    6 weeks after the end of therapy
    Title
    Boston Diagnostic Aphasia Examination
    Time Frame
    6 weeks after the end of therapy

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Adaptation of Melodic Intonation Therapy to Spanish

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