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Search / Trial NCT06381713

Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

Launched by UNIVERSITY GHENT · Apr 19, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Randomized Controlled Trial Speech Therapy Cleft Lip And Palate

ClinConnect Summary

This clinical trial is studying the effects of two different types of speech therapy for children with cleft palates. Traditionally, speech therapy has been provided at a low intensity, which means kids usually attend sessions for 30 minutes, twice a week. However, this approach has some drawbacks, such as slow progress and high costs. The trial aims to compare this low-intensity therapy with a high-intensity option, which involves more frequent sessions, to see which one helps children speak better, improves their quality of life, and is more cost-effective.

To participate in the trial, children need to be Belgian Dutch speakers, aged 4 to 12, and have a cleft palate with at least one specific speech error. Unfortunately, children with certain medical conditions, like hearing problems or cognitive disabilities, cannot join. Those who do participate can expect to receive either the high or low-intensity speech therapy and contribute to important research that could improve treatment options for future patients. The ultimate goal is to make the best therapy available for children with cleft palates and raise awareness about its benefits.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
  • Aged between 4 and 12 years,
  • Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
  • Exclusion Criteria:
  • Children with syndromic clefts
  • Oronasal fistula
  • Velopharyngeal insufficiency
  • Hearing disabilities based on pure tone audiometry (\>25 dB HL)
  • Cognitive and/or related learning disabilities or neuromuscular disorders

About University Ghent

University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.

Locations

Ghent, , Belgium

Patients applied

0 patients applied

Trial Officials

Kristiane Van Lierde, PhD

Principal Investigator

University Ghent

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported