StutteringSAS:EIPNCT01097161
Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program
A study testing speech therapy with the assistance of an acoustical analysis program in people with Stuttering and Developmental Apraxia of Speech, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stuttering, Developmental Apraxia of Speech
- What is being tested?
- speech therapy with the assistance of an acoustical analysis program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2007to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stuttering
- Clinical diagnosis of apraxia of speech
- 18 years of age or older
- Portuguese native language
- Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month period
Who cannot join
- History of major medical illness unrelated to primary diagnosis of developmental stuttering and developmental apraxia of speech
- Significant abnormalities on general physical and neurological examination unrelated to primary diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Speech Prosody of People With Stuttering and Developmental Apraxia: the Efficacy of an Intervention Program
Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.
Read the detailed description
The study has the aim of developing knowledge, methodology and technique in the prosody area, for its application on the speech therapy, with the assistance of a feedback system - with WinpitchPro (Philippe Martin). A database was constituted on the basis of a patterned corpus (EUROM1) by its translation, recording and editing on .wav format. Throughout model-sentences, an experimental intervention program initiates with the participation of 2 adults with stuttering problem and 2 with apraxia of speech. The efficacy of the therapeutic procedure is tested on the basis of the acoustical and the statistical analyses which have compared the first and the second speech samples taken before and after the twenty (20) therapy sessions held in a prosody approach only.
- Conditions
- Stuttering, Developmental Apraxia of Speech
- Being tested
- speech therapy with the assistance of an acoustical analysis program
- Keywords
- Stuttering, Apraxia of speech, Motor control, Prosody, Pitch range, Speech rate, fluency disorders
- Medical subject headings
- Stuttering, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech therapy with the assistance of an acoustical analysis programBehavioural
Two weekly speech sessions realized on individual basis for three months period
| Study group | Role | What they receive |
|---|---|---|
| Speech treatment on prosodic basis | Experimental | Patients receive 20 therapy sessions over a course of 3 months, with one double session per week. Receives: Behavioral: speech therapy with the assistance of an acoustical analysis program |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097161
- Sponsor's protocol ID
- SHA 0097/06
- Acronym
- SAS:EIP
- Status last verified
- Apr 2007
- First submitted
- 31 Mar 2010
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Speech Prosody of People With Stuttering and Developmental Apraxia: the Efficacy of an Intervention Program
- ClinicalTrials.gov ID
- NCT01097161
- Acronym / sponsor ID
- SAS:EIP / SHA 0097/06
- Conditions
- Stuttering, Developmental Apraxia of Speech
- Keywords
- Stuttering, Apraxia of speech, Motor control, Prosody, Pitch range, Speech rate, fluency disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Apr 2010 (estimated)
- 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.
Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.
Detailed description
The study has the aim of developing knowledge, methodology and technique in the prosody area, for its application on the speech therapy, with the assistance of a feedback system - with WinpitchPro (Philippe Martin). A database was constituted on the basis of a patterned corpus (EUROM1) by its translation, recording and editing on .wav format. Throughout model-sentences, an experimental intervention program initiates with the participation of 2 adults with stuttering problem and 2 with apraxia of speech. The efficacy of the therapeutic procedure is tested on the basis of the acoustical and the statistical analyses which have compared the first and the second speech samples taken before and after the twenty (20) therapy sessions held in a prosody approach only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speech treatment on prosodic basis | Experimental | Behavioral: speech therapy with the assistance of an acoustical analysis programPatients receive 20 therapy sessions over a course of 3 months, with one double session per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of stuttering
- Clinical diagnosis of apraxia of speech
- 18 years of age or older
- Portuguese native language
- Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month period
Key exclusion criteria (2 listed)
- History of major medical illness unrelated to primary diagnosis of developmental stuttering and developmental apraxia of speech
- Significant abnormalities on general physical and neurological examination unrelated to primary diagnosis
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 |
|---|---|---|
| speech therapy with the assistance of an acoustical analysis programTwo weekly speech sessions realized on individual basis for three months period | Behavioural | Speech treatment on prosodic basis |
Primary outcome
Not reported in the source record.
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 2 Apr 2010.
- Laboratório de Fonética da FALE - UFMGLink provided by the sponsor.
- Conselho nacional de SaúdeLink provided by the sponsor.
- Fundação de Amparo à pesquisa do Estado de Minas GeraisLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech therapy with the assistance of an acoustical analysis program in people with Stuttering and Developmental Apraxia of Speech, run by Federal University of Minas Gerais at 1 site in Brazil.
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 5 inclusion and 2 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 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 2 Apr 2010.