StutteringNCT03698539
How Stuttering and Gestures Influence the Intelligibility of Individuals With Down Syndrome
An observational study of Stuttering and Down Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study wants to determine the relationship between spontaneous hand gestures, stuttering and intelligibility in individuals with Down syndrome. One third of these individuals has fluency problems, such as stuttering. Gesture use appears to be a strength in individuals with Down syndrome. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Stuttering, Down Syndrome, Intelligibility, Speech
- What is being tested?
- hand gestures
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Dec 2018to 10 Sep 2021
- Phase
- Observational
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The groups will be assembled from individuals with Down syndrome and typically developing children who do and do not stutter who live in Flanders. They will be recruited via regular and special education primary schools, via speech language pathologists, via revalidation centra and via the Down syndrome association Flanders.
Who may be able to join
- Stuttering (group 1)
- No stuttering (group 2)
- Able to understand and produce a three-word sentence
- Mild to moderate mental disability
Who cannot join
- Severe mental disability
- No understanding and/or production of a three-word sentence
- Uncorrected visual or auditory impairment
- Inclusion Criteria for the typically developing participants
- Stuttering (group 1)
- No stuttering (group 2)
Show all 10Show fewer
- Able to understand and produce a three-word sentence
- No understanding and/or production of a three-word sentence
- Uncorrected visual or auditory impairment
- Other language/speech problems
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Experimental Oto-Rhino-Laryngology, Departement Neurowetenschappen
Leuven, 3000
About this study
Official title: The Interaction Between Stuttering and Gestures and Their Influence on the Intelligibility of Individuals With Down Syndrome
This study wants to determine the relationship between spontaneous hand gestures, stuttering and intelligibility in individuals with Down syndrome. One third of these individuals has fluency problems, such as stuttering. Gesture use appears to be a strength in individuals with Down syndrome. While they are able to compensate for their language problems, it is not clear if they also use gestures to compensate for their speech problems. Therefore, this study will observe the impact of their gesture use on the stuttering frequency/severity and on the intelligibility of children with Down syndrome.
This study has three research questions. The first question is: Is there a difference in gesture use between individuals with Down syndrome who stutter and individuals with Down syndrome who do not stutter? The hypothesis is that the children who stutter will make more gestures to compensate for the fluency problems. The kind of spontaneous hand gestures will also be considered. These results will be compared to those of typical developing individuals.
Read more
The second research question is: Are stuttering events that are accompanied by a gesture more intelligible than stuttering moments that are not accompanied by a gesture? Research showed that the use of signs has an positive impact on the speech intelligibility of individuals with Down syndrome. Here it is investigated if this is also true for spontaneous hand gestures. In case of better speech intelligibility it is investigated if the gain in intelligibility is caused by how recognizable the gesture is or by the effect of the gestures on speech itself. The effect of different types on the speech intelligibility of the stuttering events will also be investigated. Typically developing individuals who stutter will function as control group.
The third research question is: 'Does gestural priming have an influence on the fluency of children with Down syndrome? Gestural priming is a secondary speech signal that gives feedback to the first speech signal by simultaneously mimicking the first speech signal. In this research a hand puppet will imitate the mouth movements of the participants. Next to that, the speech will be simultaneously be accompanied by beat gestures, meaningless up and downward movements. The hypothesis is that due to mirror neurons, the participants will become more fluent. Mirror neurons are neurons in the brain that can produce a neural basis for fluency by the perception of the second speech signal.
Read the detailed description
The parents of the individuals with Down syndrome are given a questionnaire to see if their child can participate in the study. A receptive language test is administered to the individuals with Down syndrome to get an indication of their developmental age. An stuttering discrimination test and a stuttering awareness test were also developed for this study, to see if individuals with Down syndrome are able to hear the difference between stuttered and fluent speech and to see if they are aware of their stuttering. Awareness of stuttering might impact their gesture use.
For the first research question, the relationship between gestures on the stuttering frequency/severity is investigated. To collect this information, video's of spontaneous speech will be analyzed. All the participants are filmed by their parents or caregivers. During the spontaneous speech, the individuals talk about anything they want. Multiple video's with different subjects are filmed per participant since stuttering is very variable. For example, if a child is more excited by one topic than by another, it could increase the stuttering frequency. The same procedure is administered to typically developing individuals. The transcription program CLAN is used to transcribed the videos and to code the stuttering events and the gestures. After this, statistical analysis is used to see if individuals with Down syndrome who stutter differ in their gesture use from the individuals who do not stutter. Next to that, the results of the Down syndrome group will be compared to the typically developing group.
For the second research question, the videos of the individuals are used to investigate the effect of gestures on the intelligibility of stuttering events. There are two conditions: (1) Videos of stuttering events with and without a gesture and (2) audio recordings of stuttering events with and without a gesture (4).The audio recordings are identical to the information in the video recordings.
Typically developing adults who are naïeve to the research question are asked to watch or listen the video/audio recordings of the individuals with Down syndrome. For each recording they are asked to transcribe what they thought the individuals with Down syndrome had said and on a 7-point Likert scale they had to indicate how intelligible they found the speech. The intelligibility results are compared between gesture and no gesture and between audio and video.
The same protocol will be done with video/audio recordings of typically developing individuals who stutter and their results will be compared to those of the participants with Down syndrome.
For the third research question, only the group of children who stutter is retained. There are three experimental conditions and one control condition based on the procedure of Snyder, Waddell \& Blachet (2016). In the control condition, the investigator shows three pictograms on a laptop that form a sentence, for example, the cat eats cake. The participants have to produce this sentence. There is a training session to make sure the participant understands to goal of the pictograms and can produce the sentences. The actual test condition contains 7 sentences. In the control condition no gestures or priming is used. The experimental conditions are the same, but priming is induced. In the first experimental condition, the participant gets a hand puppet that must make the same mouth movements as she does, but the puppet needs to start moving before the participant starts talking. In the second experimental condition, the participant does the same thing with the hand puppet, but she has to hold it behind a screen, so she cannot see it herself. In the third condition, it is the investigator who simultaneously mimics the participant with the hand puppet. Each participant does all the conditions, but in a different order, so there is control for a saturation effect. Each experimental condition is preceded by a training session where different forms of prompting are used to teach to participants how to work with the hand puppet.
Additionally, since it is unnatural to walk around with a hand puppet, the same experiment is executed but with the use of beat gestures. These are rhythmical gestures that control the parsing of the speech stream. The children produce the sentences again but this time they make simple up and downward beat gestures during their speech or watch the experimenter make these gestures while they speak. The second experimental condition is eliminated in this case, since beat gestures are often made with two hands.
All the conditions are videotaped and transcribed in CLAN. The stuttering frequency is measured for all the conditions and compared between them. If the beat gestures have a fluency inducing effect, than this might be an indication to develop a new stuttering therapy based on spontaneous hand gestures.
- Conditions
- Stuttering, Down Syndrome, Intelligibility, Speech, Gestures
- Being tested
- hand gestures
- Keywords
- Stuttering, Down syndrome, Gestures, Intelligibility
- Medical subject headings
- Stuttering, Down Syndrome, Speech Intelligibility, Gestures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand gesturesBehavioural
We observe the use of spontaneous hand gestures in all the groups.
| Study group | Role | What they receive |
|---|---|---|
| Down syndrome who stutter | This group consists of individuals with Down syndrome who stutter. They have a mild or moderate intellectual disability and are able to understand and produce a three word sentence.
Spontaneous hand gestures and stutter frequency are investigated in this group. Receives: Behavioral: hand gestures | |
| Down syndrome who do not stutter | This group consists of individuals with Down syndrome who do not stutter. They have a mild or moderate intellectual disability and are able to understand and produce a three word sentence.
Spontaneous hand gestures are investigated in this group Receives: Behavioral: hand gestures | |
| Typically developing children who stutter | This group consists of typically developing children who stutter. They function as a control group to the individuals with Down syndrome. Receives: Behavioral: hand gestures | |
| Typically developing children who do not stutter | This group consists of typically developing children who do not stutter. They function as a control group to the individuals with Down syndrome. Receives: Behavioral: hand gestures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gesture frequency
This frequency is calculated by adding up all the gestures used by the participant and dividing it by the total of words the participant said. Tis total is multiplied by 100 to get a percentage. For example, if a participant used 10 spontaneous hand gestures in a speech sample of 50 words, he has a spontaneous hand gesture frequency of 20%. The speech samples are defined by the length of the videos. Every outing of the participant is included in the sample.
Measured: This frequency is measured in the spontaneous telling task and in the gestural priming experiment over a period of 4 - 6 months.
Stuttering frequency
This frequency is calculated for the children with Down syndrome who stutter. The total number of stuttering moments is divided by the total number of words in the speech sample. This number is multiplied by 100 to get the stutter frequency. For example, if a participant had 9 stuttering moments in a speech sample of 90 words, he would have a stutter frequency of 10%. Stuttering moments are defined by repetitions of short words, interjections, syllables or sounds, the prolongation of sounds and blockages. The stutter frequency is calculated in all the studies. The length of the videos defines the speech samples. Every outing of the participant is included in the sample.
Measured: This frequency is measured for the first, and third research question, once per participant who stutters over a period of 4-6 months.
Subjective Intelligibility
The intelligibility of the individuals who stutter is measured with a 7-point Likert scale with 1 = completely unintelligible to 7 = completely intelligible
Measured: This frequency is measured for the second research question, over a period of two months.
Objective Intelligibility
The intelligibility of the individuals who stutter is measured by comparing what the listeners transcribed to the true transcription.
Measured: This frequency is measured for the second research question, over a period of two months.
Secondary outcomes (2)
Stuttering discrimination
The ability to discriminate between stuttered and fluent speech is measured by a new test developed by the researcher.
Measured: This is measured once before the start of the first research question.
Stuttering awareness
Stuttering awareness is measures by a new test developed by the researcher.
Measured: This is measured once before the start of the first research question.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start5 Dec 2018
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for StutteringStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Marguerite-Marie Delacroix, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Inge Zink, Professor, Principal investigator, Experimental Oto-Rhino-Laryngology, Dept. Neursciences, KU LeuvenBea Maes, Professor, Principal investigator, Parenting and Special Education, Faculty of Psychology and Educational Sciences, KU LeuvenEllen Rombouts, Professor, Principal investigator, Experimental Oto-Rino-Laryngology, Department Neurosciences, KU LeuvenBabette Maessen, Master, Principal investigator, Experimental Oto-Rino-Laryngology, Department Neurosciences, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698539
- Sponsor's protocol ID
- s62049
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenwald CA, Leonard LB. Communicative and sensorimotor development of Down's syndrome children. Am J Ment Defic. 1979 Nov;84(3):296-303.
PubMed 160755Smith L, von Tetzchner S. Communicative, sensorimotor, and language skills of young children with Down syndrome. Am J Ment Defic. 1986 Jul;91(1):57-66.
PubMed 2943160Bray M, Is stuttering therapy useful for adolescents and adults with Down syndrome who are dysfluent. Procedia. 2015; 193:51-61.
Kent RD, Vorperian HK. Speech impairment in Down syndrome: a review. J Speech Lang Hear Res. 2013 Feb;56(1):178-210. doi: 10.1044/1092-4388(2012/12-0148). Epub 2012 Dec 28.
PubMed 23275397Terminology pertaining to fluency and fluency disorders: guidelines. ASHA Special Interest Division 4: Fluency and Fluency Disorders. ASHA Suppl. 1999 Mar-Apr;41(2 Suppl 19):29-36. No abstract available.
PubMed 10188303Bijlsma EK, Oosterwijk JC, Leschot NJ, Geraerdts, JPM, Prok JC, editors. Leerboek medische genetica [Textbook medical genetics]. Maarssen: Elsevier gezondheidszorg; c2005. 430 p. (Cassiman JJ, Engelen JJM, editors. Chromosomale overerving [Chromosomal inheritance]; vol.6).Dutch
Chapman RS (1997). Language development in children and adolescents with Down syndrome. Ment Retard Develop Dis Res Rev. 1997; 3: 307-312.
Fletcher P, Macwhinney B, editors. The handbook of child language. Oxford,UK:Blackwell; c1995. 800 p. (Chapman RS, editor. Language development in children and adolescents with Down syndrome; vol. 3).
Eggers K, Van Eerdenbrugh S. Speech disfluencies in children with Down Syndrome. J Commun Disord. 2018 Jan-Feb;71:72-84. doi: 10.1016/j.jcomdis.2017.11.001. Epub 2017 Nov 8.
PubMed 29129311Góral-Półrola J, Zielińska J, Jastrzebowska, G, Tarkowski, Z. Cluttering: Specific communication disorder. Acta neuropsych. 2015; 14(1): 1-15.
Guitar B. Stuttering. An integrated approach to its nature and treatment.3re ed. Baltimore: Lippincott, Williams & Wilkins; 2006. 376 p.
Hammond G, editor. Cerebral control of speech and limb movements. Amsterdam: North-Holland; c1990. 708 p. (Flanagan R, Feldman, A, Ostry. Control of human jaw and multi-joint arm movements; vol.1).
Loncke F, Nijs M, Smet L. SMOG: Spreken Met Ondersteuning van Gebaren [SMOG: Speaking With Support of Signs].4th ed. Antwerpen: Garant; 2012. 180 p. Dutch
Preus, A. Treatment of mentally retarded stutterers. J Fluency Dis. 1990; 15(4):223-233.
Chapman RS. Language learning in Down syndrome: the speech and language profile compared to adolescents with cognitive impairment of unknown origin. Downs Syndr Res Pract. 2006 Jul;10(2):61-6. doi: 10.3104/reports.306.
PubMed 16869363
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between Stuttering and Gestures and Their Influence on the Intelligibility of Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT03698539
- Acronym / sponsor ID
- s62049
- Conditions
- Stuttering, Down Syndrome, Intelligibility, Speech, Gestures
- Keywords
- Stuttering, Down syndrome, Gestures, Intelligibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Marguerite-Marie Delacroix, KU Leuven
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 9 Oct 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 wants to determine the relationship between spontaneous hand gestures, stuttering and intelligibility in individuals with Down syndrome. One third of these individuals has fluency problems, such as stuttering. Gesture use appears to be a strength in individuals with Down syndrome. While they are able to compensate for their language problems, it is not clear if they also use gestures to compensate for their speech problems. Therefore, this study will observe the impact of their gesture use on the stuttering frequency/severity and on the intelligibility of children with Down syndrome.
This study has three research questions. The first question is: Is there a difference in gesture use between individuals with Down syndrome who stutter and individuals with Down syndrome who do not stutter? The hypothesis is that the children who stutter will make more gestures to compensate for the fluency problems. The kind of spontaneous hand gestures will also be considered. These results will be compared to those of typical developing individuals.
The second research question is: Are stuttering events that are accompanied by a gesture more intelligible than stuttering moments that are not accompanied by a gesture? Research showed that the use of signs has an positive impact on the speech intelligibility of individuals with Down syndrome. Here it is investigated if this is also true for spontaneous hand gestures. In case of better speech intelligibility it is investigated if the gain in intelligibility is caused by how recognizable the gesture is or by the effect of the gestures on speech itself. The effect of different types on the speech intelligibility of the stuttering events will also be investigated. Typically developing individuals who stutter will function as control group.
The third research question is: 'Does gestural priming have an influence on the fluency of children with Down syndrome? Gestural priming is a secondary speech signal that gives feedback to the first speech signal by simultaneously mimicking the first speech signal. In this research a hand puppet will imitate the mouth movements of the participants. Next to that, the speech will be simultaneously be accompanied by beat gestures, meaningless up and downward movements. The hypothesis is that due to mirror neurons, the participants will become more fluent. Mirror neurons are neurons in the brain that can produce a neural basis for fluency by the perception of the second speech signal.
Detailed description
The parents of the individuals with Down syndrome are given a questionnaire to see if their child can participate in the study. A receptive language test is administered to the individuals with Down syndrome to get an indication of their developmental age. An stuttering discrimination test and a stuttering awareness test were also developed for this study, to see if individuals with Down syndrome are able to hear the difference between stuttered and fluent speech and to see if they are aware of their stuttering. Awareness of stuttering might impact their gesture use.
For the first research question, the relationship between gestures on the stuttering frequency/severity is investigated. To collect this information, video's of spontaneous speech will be analyzed. All the participants are filmed by their parents or caregivers. During the spontaneous speech, the individuals talk about anything they want. Multiple video's with different subjects are filmed per participant since stuttering is very variable. For example, if a child is more excited by one topic than by another, it could increase the stuttering frequency. The same procedure is administered to typically developing individuals. The transcription program CLAN is used to transcribed the videos and to code the stuttering events and the gestures. After this, statistical analysis is used to see if individuals with Down syndrome who stutter differ in their gesture use from the individuals who do not stutter. Next to that, the results of the Down syndrome group will be compared to the typically developing group.
For the second research question, the videos of the individuals are used to investigate the effect of gestures on the intelligibility of stuttering events. There are two conditions: (1) Videos of stuttering events with and without a gesture and (2) audio recordings of stuttering events with and without a gesture (4).The audio recordings are identical to the information in the video recordings.
Typically developing adults who are naïeve to the research question are asked to watch or listen the video/audio recordings of the individuals with Down syndrome. For each recording they are asked to transcribe what they thought the individuals with Down syndrome had said and on a 7-point Likert scale they had to indicate how intelligible they found the speech. The intelligibility results are compared between gesture and no gesture and between audio and video.
The same protocol will be done with video/audio recordings of typically developing individuals who stutter and their results will be compared to those of the participants with Down syndrome.
For the third research question, only the group of children who stutter is retained. There are three experimental conditions and one control condition based on the procedure of Snyder, Waddell \& Blachet (2016). In the control condition, the investigator shows three pictograms on a laptop that form a sentence, for example, the cat eats cake. The participants have to produce this sentence. There is a training session to make sure the participant understands to goal of the pictograms and can produce the sentences. The actual test condition contains 7 sentences. In the control condition no gestures or priming is used. The experimental conditions are the same, but priming is induced. In the first experimental condition, the participant gets a hand puppet that must make the same mouth movements as she does, but the puppet needs to start moving before the participant starts talking. In the second experimental condition, the participant does the same thing with the hand puppet, but she has to hold it behind a screen, so she cannot see it herself. In the third condition, it is the investigator who simultaneously mimics the participant with the hand puppet. Each participant does all the conditions, but in a different order, so there is control for a saturation effect. Each experimental condition is preceded by a training session where different forms of prompting are used to teach to participants how to work with the hand puppet.
Additionally, since it is unnatural to walk around with a hand puppet, the same experiment is executed but with the use of beat gestures. These are rhythmical gestures that control the parsing of the speech stream. The children produce the sentences again but this time they make simple up and downward beat gestures during their speech or watch the experimenter make these gestures while they speak. The second experimental condition is eliminated in this case, since beat gestures are often made with two hands.
All the conditions are videotaped and transcribed in CLAN. The stuttering frequency is measured for all the conditions and compared between them. If the beat gestures have a fluency inducing effect, than this might be an indication to develop a new stuttering therapy based on spontaneous hand gestures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Down syndrome who stutter | – | Behavioral: hand gesturesThis group consists of individuals with Down syndrome who stutter. They have a mild or moderate intellectual disability and are able to understand and produce a three word sentence. Spontaneous hand gestures and stutter frequency are investigated in this group. |
| Down syndrome who do not stutter | – | Behavioral: hand gesturesThis group consists of individuals with Down syndrome who do not stutter. They have a mild or moderate intellectual disability and are able to understand and produce a three word sentence. Spontaneous hand gestures are investigated in this group |
| Typically developing children who stutter | – | Behavioral: hand gesturesThis group consists of typically developing children who stutter. They function as a control group to the individuals with Down syndrome. |
| Typically developing children who do not stutter | – | Behavioral: hand gesturesThis group consists of typically developing children who do not stutter. They function as a control group to the individuals with Down syndrome. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The groups will be assembled from individuals with Down syndrome and typically developing children who do and do not stutter who live in Flanders. They will be recruited via regular and special education primary schools, via speech language pathologists, via revalidation centra and via the Down syndrome association Flanders.
Key inclusion criteria (4 listed)
- Stuttering (group 1)
- No stuttering (group 2)
- Able to understand and produce a three-word sentence
- Mild to moderate mental disability
Key exclusion criteria (10 listed)
- Severe mental disability
- No understanding and/or production of a three-word sentence
- Uncorrected visual or auditory impairment
- Inclusion Criteria for the typically developing participants
- Stuttering (group 1)
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 |
|---|---|---|
| hand gesturesWe observe the use of spontaneous hand gestures in all the groups. | Behavioural | Down syndrome who do not stutter, Down syndrome who stutter, Typically developing children who do not stutter, Typically developing children who stutter |
Primary outcome
Gesture frequency
Time frame: This frequency is measured in the spontaneous telling task and in the gestural priming experiment over a period of 4 - 6 months.
This frequency is calculated by adding up all the gestures used by the participant and dividing it by the total of words the participant said. Tis total is multiplied by 100 to get a percentage. For example, if a participant used 10 spontaneous hand gestures in a speech sample of 50 words, he has a spontaneous hand gesture frequency of 20%. The speech samples are defined by the length of the videos. Every outing of the participant is included in the sample.
Stuttering frequency
Time frame: This frequency is measured for the first, and third research question, once per participant who stutters over a period of 4-6 months.
This frequency is calculated for the children with Down syndrome who stutter. The total number of stuttering moments is divided by the total number of words in the speech sample. This number is multiplied by 100 to get the stutter frequency. For example, if a participant had 9 stuttering moments in a speech sample of 90 words, he would have a stutter frequency of 10%. Stuttering moments are defined by repetitions of short words, interjections, syllables or sounds, the prolongation of sounds and blockages. The stutter frequency is calculated in all the studies. The length of the videos defines the speech samples. Every outing of the participant is included in the sample.
Subjective Intelligibility
Time frame: This frequency is measured for the second research question, over a period of two months.
The intelligibility of the individuals who stutter is measured with a 7-point Likert scale with 1 = completely unintelligible to 7 = completely intelligible
Objective Intelligibility
Time frame: This frequency is measured for the second research question, over a period of two months.
The intelligibility of the individuals who stutter is measured by comparing what the listeners transcribed to the true transcription.
2 secondary outcomes
Stuttering discrimination
Time frame: This is measured once before the start of the first research question.
Stuttering awareness
Time frame: This is measured once before the start of the first research question.
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 12 Oct 2021.
- Background: PubMed 160755Greenwald CA, Leonard LB. Communicative and sensorimotor development of Down's syndrome children. Am J Ment Defic. 1979 Nov;84(3):296-303.
- Background: PubMed 2943160Smith L, von Tetzchner S. Communicative, sensorimotor, and language skills of young children with Down syndrome. Am J Ment Defic. 1986 Jul;91(1):57-66.
- BackgroundBray M, Is stuttering therapy useful for adolescents and adults with Down syndrome who are dysfluent. Procedia. 2015; 193:51-61.
- Background: PubMed 23275397Kent RD, Vorperian HK. Speech impairment in Down syndrome: a review. J Speech Lang Hear Res. 2013 Feb;56(1):178-210. doi: 10.1044/1092-4388(2012/12-0148). Epub 2012 Dec 28.
- Background: PubMed 10188303Terminology pertaining to fluency and fluency disorders: guidelines. ASHA Special Interest Division 4: Fluency and Fluency Disorders. ASHA Suppl. 1999 Mar-Apr;41(2 Suppl 19):29-36. No abstract available.
- BackgroundBijlsma EK, Oosterwijk JC, Leschot NJ, Geraerdts, JPM, Prok JC, editors. Leerboek medische genetica [Textbook medical genetics]. Maarssen: Elsevier gezondheidszorg; c2005. 430 p. (Cassiman JJ, Engelen JJM, editors. Chromosomale overerving [Chromosomal inheritance]; vol.6).Dutch
- BackgroundChapman RS (1997). Language development in children and adolescents with Down syndrome. Ment Retard Develop Dis Res Rev. 1997; 3: 307-312.
- BackgroundFletcher P, Macwhinney B, editors. The handbook of child language. Oxford,UK:Blackwell; c1995. 800 p. (Chapman RS, editor. Language development in children and adolescents with Down syndrome; vol. 3).
- Background: PubMed 29129311Eggers K, Van Eerdenbrugh S. Speech disfluencies in children with Down Syndrome. J Commun Disord. 2018 Jan-Feb;71:72-84. doi: 10.1016/j.jcomdis.2017.11.001. Epub 2017 Nov 8.
- BackgroundGóral-Półrola J, Zielińska J, Jastrzebowska, G, Tarkowski, Z. Cluttering: Specific communication disorder. Acta neuropsych. 2015; 14(1): 1-15.
- BackgroundGuitar B. Stuttering. An integrated approach to its nature and treatment.3re ed. Baltimore: Lippincott, Williams & Wilkins; 2006. 376 p.
- BackgroundHammond G, editor. Cerebral control of speech and limb movements. Amsterdam: North-Holland; c1990. 708 p. (Flanagan R, Feldman, A, Ostry. Control of human jaw and multi-joint arm movements; vol.1).
- 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.
Inge Zink, Professor principal investigator
Experimental Oto-Rhino-Laryngology, Dept. Neursciences, KU Leuven
Bea Maes, Professor principal investigator
Parenting and Special Education, Faculty of Psychology and Educational Sciences, KU Leuven
Ellen Rombouts, Professor principal investigator
Experimental Oto-Rino-Laryngology, Department Neurosciences, KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stuttering and Down Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 10 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 12 Oct 2021. 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 Belgium. 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.
What does the primary outcome measure?
Gesture frequency (time frame: This frequency is measured in the spontaneous telling task and in the gestural priming experiment over a period of 4 - 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03698539, which also lists 30 linked publications.
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 12 Oct 2021.