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Brain scans reveal how speech therapy rewires Kids' brains after cleft palate repair

NCT ID NCT07330687

Knowledge-focused Sponsor: Shufan Zhao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study used brain scans to understand how speech therapy helps children with cleft palate who have trouble speaking clearly. Researchers looked at brain connections and structure before and after therapy in 164 children aged 4 to 16. The goal was to see if therapy changes abnormal brain networks linked to speech problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Structured speech training therapy
What this could lead to
If successful, this could reveal how speech therapy rewires the brain, leading to more effective treatments for speech disorders in children with cleft palate.
What could go wrong
This is an observational brain imaging study, not a treatment trial. It may not directly improve speech outcomes, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

164 people

The number who actually took part.

Started

Jan 2019

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 16 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cleft lip/palate communication disorder speech disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRAIN Cleft lip and/or palate Magnetic resonance imaging Speech disorder Speech therapy

Contacts and locations

Locations

  • School & Hospital of Stomatology Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

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