Neural Changes After Speech Therapy in Patients With Cleft Palate: A Brain Imaging Study

NCT07330687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

  • Cleft Lip and/or Palate
  • Speech Disorder
  • Speech Therapy
  • Brain
  • Magnetic Resonance Imaging

Interventions

BEHAVIORAL

Structured Speech Training for Decompensation

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.

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    collaborator OTHER
  • Wenzhou Medical University

    collaborator OTHER
  • National Natural Science Foundation of China

    collaborator OTHER_GOV
  • Shufan Zhao

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-06
Primary Completion
2021-05-27
Completion
2021-08-21

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330687 on ClinicalTrials.gov