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

NCT ID: NCT07330687

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-06
• Study Completion Date: 2021-08-21

Brief Summary

Cleft palate is one of the most common maxillofacial congenital malformation, which results in severe speech disorders. Compensatory articulation disorder, also known as non-oral articulation disorder (NOA), is considered as the major pathological changes among these patients. However, the outcome of speech therapy, an important treatment method, for the NOA was usually unsatisfied. This is due to the wrong articulation patterns and stubborn habits in the NOA patients, which need considerable training intensity and time. According to the preliminary results of our own study, as well as studies by others, structural and functional changes were clearly identified in some brain regions of NOA patients, which suggested that the abnormal neural networks were involved in the progression of NOA. Thus, we proposed the hypothesis that the speech therapy effectively correct the articulation disorders through reconfiguration of the pathological neural function and reorganization of the abnormal neural network involved in NOA. In this proposal, multimodal brain imaging techniques will be applied to investigate the differences in the brain functional connectivity and structural connectivity networks among the groups of oral articulation (OA), different degree of NOA with postoperative cleft palate patients and health control. The relationship between the improvement of speech intelligibility and the alteration of brain network before and after intervention will be compared. We intend to reveal the substrates of the neural network associated with NOA and speech therapy. Overall, through this comprehensive study, we would like not only to provide new insight into the underlying neural mechanism of NOA, but also accumulate evidences for improving the effective speech therapy and finding new therapeutic strategy in clinical practice.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non-Oral Articulation(NOA) group

Group Type: EXPERIMENTAL

Structured Speech Training for Decompensation

Intervention Type: BEHAVIORAL

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.

Oral Articulation (OA) Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

healthy control(HC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged between 4 and 16 years.
• For patient groups: Diagnosed with non-syndromic cleft palate and having undergone cleft palate repair surgery at least 1 year prior.
• For the NOA group: Diagnosed with compensatory articulation disorder (Non-oral Articulation, NOA) through standardized speech assessment.
• For the OA group: Confirmed to have no compensatory articulation disorder (Oral Articulation, OA) through standardized speech assessment.
• For the healthy control group: No history of any craniofacial malformations, speech disorders, or neurological diseases.
• Participants and their legal guardians are able to understand and willing to provide written informed consent.
• Able to cooperate with and complete magnetic resonance imaging (MRI) examinations (e.g., no claustrophobia, no contraindicated metal implants).

Exclusion Criteria

• Presence of other known syndromes or cognitive impairments (e.g., autism spectrum disorder, intellectual disability).
• History of other neurological diseases that may affect speech function (e.g., cerebral palsy, hearing loss).
• Presence of severe other orofacial anomalies, or an unrepaired palatal fistula.
• Contraindications for MRI examination (e.g., non-removable metal implants, severe claustrophobia).
• Having received systematic speech therapy within the past 6 months.
• Any other condition deemed by the investigator to be unsuitable for participation in the study.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: collaborator

Wenzhou Medical University

OTHER

Sponsor Role: collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Shufan Zhao

OTHER

Sponsor Role: lead

Responsible Party

Shufan Zhao

PhD, Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

School & Hospital of Stomatology Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

References

Zhang W, Li C, Chen L, Xing X, Li X, Yang Z, Zhang H, Chen R. Increased activation of the hippocampus during a Chinese character subvocalization task in adults with cleft lip and palate palatoplasty and speech therapy. Neuroreport. 2017 Aug 16;28(12):739-744. doi: 10.1097/WNR.0000000000000832.

Reference Type: RESULT

PMID: 28658048 (View on PubMed)

Wang Y, Deng C, Li H, Gao Y, Shi B, Huang X, Gong Q. Intranetwork and Internetwork Functional Connectivity Changes Related to Speech Disorders in Adults With Cleft Lip and Palate. Eur J Neurosci. 2025 Apr;61(7):e70077. doi: 10.1111/ejn.70077.

Reference Type: RESULT

PMID: 40219708 (View on PubMed)

Zhang W, Guan Z, Cao L, Sun L, Zhang X, Chen R, Li C, Song W. Articulation-function-associated brain developmental changes in cleft lip and palate patients. Brain Res Bull. 2025 Sep;229:111458. doi: 10.1016/j.brainresbull.2025.111458. Epub 2025 Jul 11.

Reference Type: RESULT

PMID: 40653058 (View on PubMed)

Zhang W, Zhao C, Sun L, Yang X, Yang L, Liang Y, Zhang X, Du X, Chen R, Li C. Articulation-Function-Associated Cortical Developmental Changes in Patients with Cleft Lip and Palate. Brain Sci. 2023 Mar 25;13(4):550. doi: 10.3390/brainsci13040550.

Reference Type: RESULT

PMID: 37190514 (View on PubMed)

Wang S, Fang L, Miao G, Li Z, Rao B, Cheng H. Atypical cortical thickness and folding of language regions in Chinese nonsyndromic cleft lip and palate children after speech rehabilitation. Front Neurol. 2022 Sep 20;13:996459. doi: 10.3389/fneur.2022.996459. eCollection 2022.

Reference Type: RESULT

PMID: 36203989 (View on PubMed)

Homoud NN, Ireland AJ, Sherriff M, AlSaffar Z, Davies AJV, Sandy JR. A Review and Meta-Analysis on Altered Brain Structure in Patients Born with Non-Syndromic Cleft Lip and/or Palate. Cleft Palate Craniofac J. 2025 Mar 24:10556656251327526. doi: 10.1177/10556656251327526. Online ahead of print.

Reference Type: RESULT

PMID: 40129165 (View on PubMed)

Other Identifiers

2017021923

Identifier Type: -

Identifier Source: org_study_id