Adaptation of Melodic Intonation Therapy to Spanish

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

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)

Study Overview

• Status: Completed
• Conditions: Post Stroke Aphasia
• Intervention / Treatment: Other: Melodic Intonation Therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Other: Melodic Intonation Therapy
NO_INTERVENTION: Waiting list; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Communicative Activity Log questionnaire	6 weeks after the end of therapy
Boston Diagnostic Aphasia Examination	6 weeks after the end of therapy

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2010
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: stroke; aphasia; melodic intonation therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: PI-894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No