Down Syndrome Clinical Trial
Official title:
The Interaction Between Stuttering and Gestures and Their Influence on the Intelligibility of Individuals With Down Syndrome
NCT number | NCT03698539 |
Other study ID # | s62049 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 5, 2018 |
Est. completion date | September 10, 2021 |
Verified date | October 2021 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 10, 2021 |
Est. primary completion date | September 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 21 Years |
Eligibility | Inclusion Criteria for the participants with Down syndrome - Stuttering (group 1) - No stuttering (group 2) - Able to understand and produce a three-word sentence - Mild to moderate mental disability Exclusion Criteria: - 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) - Able to understand and produce a three-word sentence Exclusion Criteria: - No understanding and/or production of a three-word sentence - Uncorrected visual or auditory impairment - Other language/speech problems |
Country | Name | City | State |
---|---|---|---|
Belgium | Experimental Oto-Rhino-Laryngology, Departement Neurowetenschappen | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | KU Leuven, Marguerite-Marie Delacroix |
Belgium,
Arenas, R. M. Conceptualizing and investigating the contextual variability of stuttering: The speech and monitoring interaction (SAMI) framework. Speech, Lang. Hear. 20, 15-28 (2017).
Bijlsma 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
Bray M, Is stuttering therapy useful for adolescents and adults with Down syndrome who are dysfluent. Procedia. 2015; 193:51-61.
Chapman RS (1997). Language development in children and adolescents with Down syndrome. Ment Retard Develop Dis Res Rev. 1997; 3: 307-312.
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. — View Citation
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).
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. — View Citation
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).
Galeote M, Sebastián E, Checa E, Rey R, Soto P. The development of vocabulary in Spanish children with Down syndrome: comprehension, production, and gestures. J Intellect Dev Disabil. 2011 Sep;36(3):184-96. doi: 10.3109/13668250.2011.599317. — View Citation
Garcia JM, Cannito MP. Influence of verbal and nonverbal contexts on the sentence intelligibility of a speaker with dysarthria. J Speech Hear Res. 1996 Aug;39(4):750-60. — View Citation
Góral-Pólrola J, Zielinska J, Jastrzebowska, G, Tarkowski, Z. Cluttering: Specific communication disorder. Acta neuropsych. 2015; 14(1): 1-15.
Greenwald CA, Leonard LB. Communicative and sensorimotor development of Down's syndrome children. Am J Ment Defic. 1979 Nov;84(3):296-303. — View Citation
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).
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. — View Citation
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. Review. — View Citation
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
Mayberry RI, Jaques J, DeDe G. What stuttering reveals about the development of the gesture-speech relationship. New Dir Child Dev. 1998 Spring;(79):77-87. — View Citation
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. — View Citation
Preus, A. Treatment of mentally retarded stutterers. J Fluency Dis. 1990; 15(4):223-233.
Pruess JB, Vadasy PF, Fewell RR. Language development in children with Down syndrome. Educ Train Ment Retard. 1987; 22(1): 44-55.
Roberts JE, Price J, Malkin C. Language and communication development in Down syndrome. Ment Retard Dev Disabil Res Rev. 2007;13(1):26-35. Review. — View Citation
Saltuklaroglu T, Kalinowski J. The inhibition of stuttering via the perceptions and production of syllable repetitions. Int J Neurosci. 2011 Jan;121(1):44-9. doi: 10.3109/00207454.2011.536361. — View Citation
Schaerlaekens A. [Assessing and measuring language development in the child. The Reynell Scales in a Dutch language area]. Folia Phoniatr Logop. 1995;47(6):303-9. German. — View Citation
Smith 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. — View Citation
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. — View Citation
St. Louis KO, Myers, FL. Clinical management of cluttering. Lang Speech Hear Serv Schools. 1995; 26(2): 187-195.
Terminology 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. — View Citation
Velthuijs M. Een taart voor kleine beer [A pie for little bear]. Rijswijk: De Vier Windstreken;1995. 27 p. Dutch
Willems RM, Hagoort P. Neural evidence for the interplay between language, gesture, and action: a review. Brain Lang. 2007 Jun;101(3):278-89. Epub 2007 Apr 9. Review. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Stuttering discrimination | The ability to discriminate between stuttered and fluent speech is measured by a new test developed by the researcher. | This is measured once before the start of the first research question. | |
Secondary | Stuttering awareness | Stuttering awareness is measures by a new test developed by the researcher. | This is measured once before the start of the first research question. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04854122 -
Blood Flow Regulation in Individuals With Down Syndrome - Training Study
|
N/A | |
Completed |
NCT04020302 -
Self-Monitoring Shopping Intervention
|
N/A | |
Recruiting |
NCT01950624 -
DS-Connect {TM}: The Down Syndrome Registry
|
||
Completed |
NCT04751136 -
the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome
|
Phase 2 | |
Completed |
NCT04767412 -
Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial
|
N/A | |
Not yet recruiting |
NCT04037579 -
Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
|
||
Completed |
NCT04536506 -
Bobath and Vojta Therapy for DS
|
N/A | |
Completed |
NCT02882698 -
Performance Analysis in Down Syndrome on Mobile Phone
|
N/A | |
Completed |
NCT01791725 -
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
|
Phase 2 | |
Unknown status |
NCT01975545 -
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
|
Phase 2 | |
Completed |
NCT01808508 -
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
|
N/A | |
Terminated |
NCT00754013 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
|
Phase 3 | |
Terminated |
NCT00754052 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17
|
Phase 3 | |
Completed |
NCT01313325 -
Hippotherapy to Improve the Balance of Children With Movement Disorders
|
N/A | |
Completed |
NCT01256112 -
Parent Supported Weight Reduction in Down Syndrome
|
N/A | |
Completed |
NCT01594346 -
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
|
Phase 3 | |
Completed |
NCT05343468 -
Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
|
N/A | |
Suspended |
NCT05755464 -
Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
|
||
Recruiting |
NCT04022460 -
Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
|
||
Completed |
NCT04818437 -
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
|
N/A |