An observational study in Childhood Apraxia of Speech, sponsored by IRCCS Fondazione Stella Maris. Completed at 1 site in Italy. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by IRCCS Fondazione Stella Maris · Observational
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.
Background: Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose etiological, neuroanatomical and genetic correlates are largely unknown. In this trial the effects of an innovative rehabilitative approach, PROMPT (PROMPTS for Restructuring Oral Muscular Phonetic Targets) will be evaluated from a behavioral and neuroanatomical point of view.
Objective: the current study is aimed to assess speech-language and white matter microstructure and volumetric changes induced by the PROMPT treatment.
Participants: Twenty-two Children with CAS aged 4 -12 years are enrolled and assigned to a PROMPT treatment (PROMPT-t ) or a Language and Non-Speech Oral Motor-treatment group (LNSOM-t).
Methods: All children with CAS will undergo a comprehensive clinical, neurological and speech-language assessment. The following procedures will be applied: a) anamnestic interview b) oral non verbal and verbal movements eveluation c) phonetic inventory, accuracy and consistency of speech d) DDK (Diadochokinetic rate, receptive and expressive vocabulary and grammar tests; f) spontaneous language analysis. These multiple measurements were aggregated and converted into a speech and language composite score.
MRI data will be acquired using a 1.5 T MR scanner. Structural images obtained with a 3D isotropic T1 weighted sequence will be analysed to evaluate volumetric alterations, to investigate cortical thickness and automatically delineate various Regions of Interest (ROIs). HARDI images will be acquired using 32 gradient directions and will be processed using tools available in FSL and MRtrix. Tract-based spatial statistics (TBSS) will be used to statistically analyse images of FA and mean diffusivity. Fiber tracts will be calculated using constrained spherical deconvolution and probabilistic tractography. Connectomes will be calculated by combining ROIs obtained from the structural images with tractography. Network-based analysis will be used to statistically analyse connectomes.
Speech and language assessment and brain MRI VBM and DTI analysis will be performed at baseline and at the end of the treatment.
Statistical analysis: Paired t-test on pre and post treatment behavioural and MRI/DTI measures will be performed to assess the changes within each of the two groups. Moreover, comparisons between the two groups at T0 and T1 will be performed by means of non parametric tests.
Evaluation of potentially training-induced changes of brain structural connectivity may provide further support to the hypothesis that CAS is due to a disruption of networks subserving the speech production system.
65 studies on the registry are indexed under Apraxias; 21 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 12 observational studies indexed under Apraxias.
Browse Apraxias studies →IRCCS Fondazione Stella Maris is the lead sponsor of 46 studies on the registry; 27 are open to participants now.
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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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
PROMPTs for Restructuring Oral Muscolar Phonetic Targets
Language Non-Speech Oral Motor Treatment
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)
Time frame: At baselin and at 7 months of individual speech and language training
Post treatment Diffusion Weighed Imaging (DWI) metrics
Fractional Anisotropy (FA)
Time frame: At baseline and at 7 months of speech and language training
Post treatment Diffusion Weighed Imaging (DWI) changes
MD (Mean Diffusivity)
Time frame: At baseline and at 7 months of speech and language training
Post treatment cortical volumes modifications
Cortical thickness
Time frame: At baseline and at 7 months of speech and language training
Post treatment cortical volumes changes
Volumes analysis
Time frame: At baseline and at 7 months of speech and language training
Plan to share: Undecided — The results of each individual participant's evaluations will be coded and entered in a computerized database. Descriptive statistical analyses may be shared with other researchers on request .
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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IRCCS Fondazione Stella Maris