An interventional study of Structured Speech Training for Decompensation in Cleft Lip and/or Palate, Speech Disorder and Speech Therapy, sponsored by Shufan Zhao. Completed at 1 site in China. Open to participants aged 4 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Shufan Zhao · Not applicable, Interventional, and Treatment
Cleft palate is one of the most common maxillofacial congenital malformations, which results in severe speech disorders. Compensatory articulation disorder, also known as non-oral articulation disorder (NOA), is considered as the major pathological change among these patients. However, the outcome of speech therapy, an important treatment method, for NOA is often unsatisfactory. This is attributed to the erroneous articulation patterns and entrenched habits in patients with NOA, which require considerable training intensity and time. According to preliminary results from the investigators' own study, as well as studies by others, structural and functional changes have been clearly identified in some brain regions of patients with NOA, suggesting that abnormal neural networks are involved in the progression of NOA. Thus, the investigators proposed the hypothesis that speech therapy effectively corrects articulation disorders through reconfiguration of pathological neural function and reorganization of the abnormal neural network involved in NOA. In this study, multimodal brain imaging techniques will be applied to investigate differences in brain functional connectivity and structural connectivity networks among groups with oral articulation (OA), varying degrees of NOA in postoperative cleft palate patients, and healthy controls. The relationship between improvement in speech intelligibility and alterations in brain networks before and after intervention will be compared. This study aims to reveal the neural network substrates associated with NOA and speech therapy. Overall, through this comprehensive study, the investigators aim not only to provide new insight into the underlying neural mechanism of NOA but also to accumulate evidence for improving the efficacy of speech therapy and discovering new therapeutic strategies in clinical practice.
Cleft palate often leads to compensatory articulation disorder (Non-oral Articulation, NOA), which is resistant to conventional speech therapy. This study is grounded in the hypothesis that the efficacy of speech training is mediated by the reorganization of pathological neural networks and structures associated with NOA.
This non-randomized, longitudinal study employs a parallel-group design involving three cohorts: patients with NOA receiving speech training, postoperative cleft palate patients with normal oral articulation (OA) as a clinical control, and healthy controls. The primary objective is to identify the distinctive neural signatures (in both functional connectivity and brain structure) linked to NOA and its remediation through training.
All participants undergo multimodal magnetic resonance imaging (including high-resolution T1-weighted and resting-state functional scans) and standardized speech assessments at baseline. Only the NOA group then receives a structured speech training intervention, followed by post-intervention reevaluation. By comparing changes within and between groups, this study aims to disentangle neural alterations specific to NOA from those related to cleft palate in general.
The integrative analysis of brain-wide changes with a focus on speech-related regions is expected to provide a systems-level understanding of the neural mechanisms underlying NOA and treatment-induced recovery. The findings may contribute to the development of more effective, neuroscience-informed therapeutic strategies.
77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.
This study's enrollment of 164 is above the median of 38 across 54 interventional studies indexed under Speech Disorders.
Browse Speech Disorders studies →This is the only study on the registry with Shufan Zhao as lead sponsor.
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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.
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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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the investigational behavioral intervention: Structured Speech Decompensation Therapy. This one-on-one therapy uses the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits, integrating multisensory cues. The intervention is administered by a certified speech therapist at a dosage of 1-hour sessions, with a frequency of 3 sessions per week, for a duration of 5 to 12 weeks. Parent participation in sessions and daily prescribed home practice are required components.
Behavioral: Structured Speech Training for Decompensation
Participants do not receive the investigational speech training intervention. This arm serves as the clinical control group.
Participants do not receive any study-related intervention. This arm serves as the healthy normative control group.
This structured, one-on-one speech decompensation therapy targets Non-oral Articulation Disorder (NOA) in postoperative cleft palate patients, using the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits. It follows a structured paradigm from error recognition to generalization, integrating multisensory cues. Delivered by a therapist 3 times/week for 1 hour over 5-12 weeks with parent participation, it includes daily home practice. Completion requires accurate sound production, with daily parent-supervised maintenance practice for one year thereafter.
Change in Functional Connectivity of the Speech Related Network
Change in resting-state functional connectivity, focusing on connections between pre-defined speech-related regions (Broca's and Wernicke's areas) and additionally assessed through whole-brain network analysis, using resting-state fMRI data.
Time frame: From baseline assessment to post-training assessment (approximately at Week 12)
Change in Percent Correct Consonants (PCC)
Change in the percentage of consonants produced correctly, assessed within both single-word and conversational speech contexts. The measure is derived from standardized speech samples, which are evaluated by blinded, certified speech-language pathologists.
Time frame: From baseline assessment to post-training assessment (approximately at Week 12)
Change in Grey Matter Volume (GMV) of Articulation-Related Regions
Alterations in grey matter volume across the whole brain, with a focus on regions implicated in articulation. Measured by voxel-based morphometry (VBM) analysis of high-resolution T1-weighted magnetic resonance imaging (MRI) scans.
Time frame: From baseline to post-training assessment (at Week 12)
Change in Regional Homogeneity (ReHo) in Speech-Related Cortex
Changes in local brain activity synchronization across the whole brain, with particular emphasis on the speech-related cortex.
Time frame: From baseline to post-training assessment (at Week 12)
Change in Amplitude of Low-Frequency Fluctuations (fALFF)
Changes in the fractional amplitude of low-frequency fluctuations in the blood-oxygen-level-dependent (BOLD) signal across the whole brain, assessed within regions of the speech and auditory processing networks. Derived from resting-state fMRI data.
Time frame: From baseline to post-training assessment (at Week 12)
Change in Proportion of Compensatory Articulation Errors
Change in the proportion of compensatory (non-oral) articulation errors relative to the total number of consonants attempted, analyzed within both single-word and conversational speech samples. This metric is calculated through phonetic transcription of the speech samples to quantify the frequency of error patterns characteristic of non-oral articulation.
Time frame: From baseline to post-training assessment (at Week 12)
Change in White Matter Volume (WMV) of Articulation-Related Regions
Alterations in white matter volume across the whole brain, particularly within tracts associated with speech motor pathways. Analyzed using voxel-based analysis of T1-weighted MRI to quantify white matter volume changes.
Time frame: From baseline to post-training assessment (at Week 12)
Plan to share: No — A final decision regarding the sharing of individual participant data (IPD) has not been made at the time of this registration. This study involves sensitive neuroimaging and speech data. Data sharing considerations, including the feasibility of complete de-identification, compliance with local regulations and ethical approvals, and the establishment of appropriate data access protocols, require further review by the study investigators and sponsoring institution. A formal data sharing plan may be developed in the future and will be made available upon reasonable request or via a controlled-access repository if deemed feasible and appropriate.
Ran from Jan 2019 to primary completion in May 2021, 28 months.
Of 35 non-industry interventional studies with no phase under Speech Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 38. This study's 28 months is close to that.
Counting every sponsor, half of 37 studies reached it within 28 months; a quarter within 17 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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