ArticlePilot and feasibility studies2022
Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate.
Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06831396 (Communication in Children With or Without Biomedical Conditions), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- The Effectiveness of Ultrasound Visual Biofeedback in Articulation Therapy for Children and Adolescents With Speech Sound Disorders: A Systematic Review and Meta-Analysis.International journal of language & communication disordersPooled it
- Visual Biofeedback (VB) through Trans-Perineal Ultrasound (TPU) during the active second stage of labor to improve maternal childbirth satisfaction: protocol of a randomized controlled trial.BMC pregnancy and childbirth · 2026Trial
- A mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip: Parents' and children's perspectives.International journal of language & communication disordersTrial
- Quantitative results of SonoSpeech Cleft Pilot: a mixed-methods pilot randomised control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip.Pilot and feasibility studies · 2025Article
- Ultrasound Tongue Imaging in Research and Practice with People with Cleft Palate ± Cleft Lip.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2025Review
- An initial framework for use of ultrasound by speech and language therapists in the UK: Scope of practice, education and governance.Ultrasound (Leeds, England) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundChildren with cleft lip and palate can continue to have problems producing clear speech after surgery. This can lead to social, emotional, and educational challenges. Typical treatment involves teaching children the correct tongue movements to produce speech sounds. This is known as articulation intervention. However, this intervention is challenging because the tongue is hidden from view and movements are difficult to see and describe. This pilot randomized control trial will try a new treatment, ultrasound visual biofeedback (U-VBF) versus standard articulatory intervention for children with cleft lip and palate, as comparison. Feasibility outcomes will be determined. METHODS/
designThe Sonospeech project will enroll up to 40 children with cleft lip and palate aged 4;6 to 16 in a mixed-methods randomized controlled trial with blinded assessors. Children will receive either six sessions of U-VBF or articulation intervention. The primary goals of this pilot are to assess the feasibility and inform the design of a full-scale RCT of U-VBF for children with cleft speech characteristics. This will be achieved by determining the following outcome measures: recruitment/attrition rates; measures of pre-post follow-up completion; and acceptability of the randomization and interventions to families. DISCUSSION: Larger trials of speech interventions for children with cleft lip and palate are needed. This pilot/feasibility study will determine whether a larger randomized control trial comparing ultrasound and articulation interventions is feasible.
trial registrationISRCTN, ISRCTN17441953 . Registered 22 March 2021. See Table 2 in Appendix 1 for all items.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.