NCT03698539

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

October 4, 2018

Last Update Submit

October 4, 2021

Conditions

Keywords

StutteringDown syndromeGesturesIntelligibility

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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.

    This frequency is measured for the second research question, over a period of two months.

Secondary Outcomes (2)

  • Stuttering discrimination

    This is measured once before the start of the first research question.

  • Stuttering awareness

    This is measured once before the start of the first research question.

Study Arms (4)

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.

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

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.

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.

Behavioral: hand gestures

Interventions

hand gesturesBEHAVIORAL

We observe the use of spontaneous hand gestures in all the groups.

Down syndrome who do not stutterDown syndrome who stutterTypically developing children who do not stutterTypically developing children who stutter

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Stuttering (group 1)
  • No stuttering (group 2)
  • Able to understand and produce a three-word sentence
  • Mild to moderate mental disability

You may not qualify if:

  • Severe mental disability
  • No understanding and/or production of a three-word sentence
  • Uncorrected visual or auditory impairment
  • Stuttering (group 1)
  • No stuttering (group 2)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental Oto-Rhino-Laryngology, Departement Neurowetenschappen

Leuven, 3000, Belgium

Location

Related Publications (30)

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    PMID: 160755BACKGROUND
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    PMID: 29129311BACKGROUND
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    BACKGROUND
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    PMID: 16869363BACKGROUND
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    PMID: 21843033BACKGROUND
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    PMID: 17326116BACKGROUND
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    PMID: 9507705BACKGROUND
  • Snyder GJ, Waddell DE, Blanchet P. Mirror neurons as a model for the science and treatment of stuttering. Neuroreport. 2016 Jan 6;27(1):56-60. doi: 10.1097/WNR.0000000000000500.

    PMID: 26565808BACKGROUND
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  • Kalinowski J, Stuart A, Rastatter MP, Snyder G, Dayalu V. Inducement of fluent speech in persons who stutter via visual choral speech. Neurosci Lett. 2000 Mar 10;281(2-3):198-200. doi: 10.1016/s0304-3940(00)00850-8.

    PMID: 10704777BACKGROUND
  • Willems RM, Hagoort P. Neural evidence for the interplay between language, gesture, and action: a review. Brain Lang. 2007 Jun;101(3):278-89. doi: 10.1016/j.bandl.2007.03.004. Epub 2007 Apr 9.

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  • Velthuijs M. Een taart voor kleine beer [A pie for little bear]. Rijswijk: De Vier Windstreken;1995. 27 p. Dutch

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  • Meuris K, Maes B, Zink I. Evaluation of language and communication skills in adult key word signing users with intellectual disability: advantages of a narrative task. Res Dev Disabil. 2014 Oct;35(10):2585-601. doi: 10.1016/j.ridd.2014.06.020. Epub 2014 Jul 10.

    PMID: 25016435BACKGROUND
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  • Clibbens, J. & Powell, G. Actions speak louder than words: signing and speech intelligibility in adults with Down syndrome. Down Syndr. Res. Pract. 2, 127-129 (2007).

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    PMID: 8844555BACKGROUND

MeSH Terms

Conditions

StutteringDown SyndromeSpeech IntelligibilityGestures

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsIntellectual DisabilityAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornSpeechVerbal BehaviorCommunicationBehaviorKinesicsNonverbal Communication

Study Officials

  • Inge Zink, Professor

    Experimental Oto-Rhino-Laryngology, Dept. Neursciences, KU Leuven

    PRINCIPAL INVESTIGATOR
  • Bea Maes, Professor

    Parenting and Special Education, Faculty of Psychology and Educational Sciences, KU Leuven

    PRINCIPAL INVESTIGATOR
  • Ellen Rombouts, Professor

    Experimental Oto-Rino-Laryngology, Department Neurosciences, KU Leuven

    PRINCIPAL INVESTIGATOR
  • Babette Maessen, Master

    Experimental Oto-Rino-Laryngology, Department Neurosciences, KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

December 5, 2018

Primary Completion

September 10, 2021

Study Completion

September 10, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations