Childhood Apraxia of Speech: Experience Dependent Changes Induced by Treatment

NCT04832503 | Completed

• 1 other identifier: RF-2016-02361560
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose aetiological, neuroanatomical correlates are largely unknown. Furthermore, little is known about the neuroplastic effects induced by different treatment approaches and their relationships with the potential changes in the speech behavioural features that express the core deficit of CAS. Twenty four children with idiopathic CAS will be enrolled in a multidisciplinary study aimed at analysing the behavioural and neuroanatomical effects of a specific rehabilitative approach, PROMPT (PROMPTs for Restructuring Oral Muscular Phonetic Targets), that employs tactile-kinesthetic-proprioceptive cues vs a traditional speech-language treatment. The children will be allocated in two arms, one receiving a seven month cycle of individual PROMPT treatment, the other a traditional speech and language treatment for the same amount of time.The pre- and post-treatment speech and language performances and DTI and volumetric MR data will be compared in the two groups.

Conditions

Childhood Apraxia of Speech

Keywords

Treatment induced speech changes; PROMPT; MRI; Neuroplasticity

Outcome Measures

Primary Outcomes (1)

• Speech Composite Severity Score changes after 7 months of treatment

  Speech Severity Score aggregates measures of DDK, inaccuracy, inconsistency, Phonetic inventory, Syllable Omissions. Score ranges form: 0 (normal) to 5 (severely impaired)

  At baselin and at 7 months of individual speech and language training

Secondary Outcomes (4)

• Post treatment Diffusion Weighed Imaging (DWI) metrics

  At baseline and at 7 months of speech and language training

• Post treatment Diffusion Weighed Imaging (DWI) changes

  At baseline and at 7 months of speech and language training

• Post treatment cortical volumes modifications

  At baseline and at 7 months of speech and language training

• Post treatment cortical volumes changes

  At baseline and at 7 months of speech and language training

Study Arms (2)

Group 1

The PROMPT-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at treatment planning. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided in order to shape speech movements, to give information on sequencing and timing, and to introduce constraints for the reduction of the degrees of freedom at the articulators' level in favour of motor control. In a PROMPT session the syllables, words and phrases are produced within a communicative context in play. Speech motor goals are, as soon as possible, integrated in goals for language and functional communication.

Behavioral: PROMPT- treatment

GROUP 2

The LNSOM-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at the treatment planning. None of the SLTs treating this group are PROMPT trained. According to the standard care methods used in Italy, the intervention consists of a linguistic and articulatory approach that includes auditory discrimination of phonemic categories at the syllable and word level and non-speech oral motor exercises. Receptive and expressive lexicon and morphosyntax are targeted depending on the children's linguistic profile.Differently from the PROMPT, selection of speech sounds to be targeted, is based on developmental speech sounds acquisition rather than motor criteria. According to this treatment approach, the motor goal is usually identified with the placement of the main articulator involved in the production of a speech sound.

Behavioral: LNSOM-treatment

Interventions

PROMPT- treatment BEHAVIORAL

PROMPTs for Restructuring Oral Muscolar Phonetic Targets

Group 1

LNSOM-treatment BEHAVIORAL

Language Non-Speech Oral Motor Treatment

GROUP 2

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

24 children with idiopathic CAS aged between 4 and 12 years. All the chidren are able to collaborate during MRI acquisition and behavioural assessment and to actively participate in the treatment sessions. To facilitate children's collaboration during MRI execution, a 0 Tesla simulator, reproducing the MRI setting of evaluation will be applied. Moreover during MRI acquisition children will be invited to watch cartoons through special glasses

You may qualify if:

• Diagnosis of idiopathic CAS based on the presence of specific diagnostic features of apraxia of speech (see ASHA and Strand et al's criteria) and on a comprehensive clinical and neurological assessment.
• Non-verbal IQ within the normal range at standardized tests of intelligence.
• Normal structural brain MRI.
• Acquisition of parents' informed consent to the execution of behavoiural and neuroradiological assessment at baseline and to perform speech/language treatment.

You may not qualify if:

• Orofacial structural abnormalities.
• Known pathologies of neurological, neurometabolical and genetic etiologies.
• Audiological deficits.
• Epilepsy.
• Intellectual disability.
• Autism spectrum disorder.

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS Fondazione Stella Maris

Tirrenia, Tuscany, 56128, Italy

Location

Related Publications (6)

• Kadis DS, Goshulak D, Namasivayam A, Pukonen M, Kroll R, De Nil LF, Pang EW, Lerch JP. Cortical thickness in children receiving intensive therapy for idiopathic apraxia of speech. Brain Topogr. 2014 Mar;27(2):240-7. doi: 10.1007/s10548-013-0308-8. Epub 2013 Aug 24.

  PMID: 23974724 BACKGROUND

• Fiori S, Guzzetta A, Mitra J, Pannek K, Pasquariello R, Cipriani P, Tosetti M, Cioni G, Rose SE, Chilosi A. Neuroanatomical correlates of childhood apraxia of speech: A connectomic approach. Neuroimage Clin. 2016 Nov 4;12:894-901. doi: 10.1016/j.nicl.2016.11.003. eCollection 2016.

  PMID: 27882295 BACKGROUND

• Square PA, Namasivayam AK, Bose A, Goshulak D, Hayden D. Multi-sensory treatment for children with developmental motor speech disorders. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):527-42. doi: 10.1111/1460-6984.12083. Epub 2014 Mar 12. No abstract available.

  PMID: 24617702 BACKGROUND

• Morgan AT, Su M, Reilly S, Conti-Ramsden G, Connelly A, Liegeois FJ. A Brain Marker for Developmental Speech Disorders. J Pediatr. 2018 Jul;198:234-239.e1. doi: 10.1016/j.jpeds.2018.02.043. Epub 2018 Apr 25.

  PMID: 29705112 BACKGROUND

• Dale PS, Hayden DA. Treating speech subsystems in childhood apraxia of speech with tactual input: the PROMPT approach. Am J Speech Lang Pathol. 2013 Nov;22(4):644-61. doi: 10.1044/1058-0360(2013/12-0055). Epub 2013 Jun 28.

  PMID: 23813194 BACKGROUND

• Namasivayam AK, Huynh A, Granata F, Law V, van Lieshout P. PROMPT intervention for children with severe speech motor delay: a randomized control trial. Pediatr Res. 2021 Feb;89(3):613-621. doi: 10.1038/s41390-020-0924-4. Epub 2020 May 1.

  PMID: 32357364 BACKGROUND

MeSH Terms

Conditions

Apraxias

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Chilosi

  IRCCS Stella Maris Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Head of Neurolinguistic and Neuropsychological Research Laboratory. Coordinator of the Clinical Neuropsichological Unit

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: April 5, 2021
• Study Start: September 30, 2018
• Primary Completion: January 30, 2023
• Study Completion: March 30, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

IT (1)