CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
Structured Speech Training for Decompensationbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07330687
NCT07330687N/ACompleted

A Brain Imaging Study of Abnormal Neural Network Reorganization Following Speech Training in Patients With Compensatory Articulation Secondary to Cleft Palate

Shufan Zhao·interventional·Posted Jan 9, 2026·Updated Feb 3, 2026

In Brief

A clinical study evaluating Structured Speech Training for Decompensation for Cleft Lip and/or Palate and 4 related conditions. Completed, enrolled 164 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 9, 2026
Enrollment StartJan 6, 2019
Primary CompletionMay 27, 2021
Study CompletionAug 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6 months ago

Interventions

Structured Speech Training for Decompensationbehavioral

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.