Post Stroke AphasiaNCT03433495
Adaptation of Melodic Intonation Therapy to Spanish
A study testing Melodic Intonation Therapy in people with Post Stroke Aphasia, run by Instituto de Investigación Hospital Universitario La Paz.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Stroke Aphasia
- What is being tested?
- Melodic Intonation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: 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)
- Conditions
- Post Stroke Aphasia
- Being tested
- Melodic Intonation Therapy
- Keywords
- stroke, aphasia, melodic intonation therapy
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melodic Intonation TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Melodic Intonation Therapy |
| Waiting list | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communicative Activity Log questionnaire
Measured: 6 weeks after the end of therapy
Boston Diagnostic Aphasia Examination
Measured: 6 weeks after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study startFeb 2010
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433495
- Sponsor's protocol ID
- PI-894
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Melodic Intonation Therapy to Spanish: a Feasibility and Validation Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03433495
- Acronym / sponsor ID
- PI-894
- Conditions
- Post Stroke Aphasia
- Keywords
- stroke, aphasia, melodic intonation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melodic Intonation Therapy | Active comparator | Other: Melodic Intonation TherapyThe 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. |
| Waiting list | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- The patient was motivated, emotionally stable and had good attention.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melodic Intonation Therapy | Other | Melodic Intonation Therapy |
Primary outcome
Communicative Activity Log questionnaire
Time frame: 6 weeks after the end of therapy
Boston Diagnostic Aphasia Examination
Time frame: 6 weeks after the end of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Melodic Intonation Therapy in people with Post Stroke Aphasia, run by Instituto de Investigación Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communicative Activity Log questionnaire (time frame: 6 weeks after the end of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.