Condition category
Oral Health
Date applied
20/01/2017
Date assigned
27/01/2017
Last edited
30/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
When a baby is born with an opening in the roof of their mouth this is known as a cleft palate. The reason babies are born this way is unknown. Surgery can fix a cleft palate, however it can cause future problems for children learning how to speak, requiring the help of speech and language therapy. The normal therapy is for Speech and Language Therapists (SLTs) to listen to a child speak and help children say the correct sounds based on what they hear, assuming the child does not know the difference between different sounds. However, there are now tools (such as ultrasounds that use sound waves to make a picture) allow a view of the tongue while speaking and this shows that children are making unnoticeable errors, changing how a SLT should help their patients with their speech. This study has two parts and aims to develop a way to evaluate speech for children with cleft palates using an ultrasound to allow a child to see their tongue move in real time and correct their speech using visual aids.

Who can participate?
Children aged 3-15 with cleft palates who speak English

What does the study involve?
Participants in the first part of the study (study 1) spend an extra 10 to 20 minutes of their usual therapy appointment having an ultrasound recording made while they are speaking. This involves sitting in a small room with a speech and language therapist and having their tongue scanned with an ultrasound machine (placed under the chin) while they name some pictures and read some sentences.
Participants in the treatment study (study 2) take part in the treatment during their regular speech therapy appointments. Instead of standard speech therapy, they use the ultrasound machine to view their own tongue moving when they speak to help them to learn speech sounds more quickly. After three initial treatments, this therapy continues for ten weeks with follow up on week 14 and week 2 to see if their speech has improved.

What are the possible benefits and risks of participating?
Participants who take part will benefit from having an in-depth speech and language assessment and a course of speech therapy which may help them with their speech disorder. There are no notable risks involved with participating, although some participants may experience some mild discomfort from wearing the ultrasound headset as it can start to feel heavy after around 30 minutes.

Where is the study run from?
Glasgow Dental Hospital and School (UK)

When is the study starting and how long is it expected to run for?
May 2016 to July 2018

Who is funding the study?
Action Medical Research (UK)

Who is the main contact?
Dr Joanne Cleland
joanne.cleland@strath.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanne Cleland

ORCID ID

http://orcid.org/0000-0002-0660-1646

Contact details

University of Strathclyde
School of Psychological Sciences and Health
Room 550
Graham Hills Building
40 George Street
Glasgow
G1 1QE
United Kingdom
+44 141 548 3037
joanne.cleland@strath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

Visualising speech: using ultrasound visual biofeedback to diagnose and treat speech disorders in children with cleft lip and palate

Acronym

Study hypothesis

Study 1: The aim of this study is to develop an ultrasound-based diagnostic assessment for identify imperceptible speech errors in children with a cleft palate to be a tool for clinical practice and circumvent practical problems associated with electropalatography (EPG).

Study 2: The aim of this study is to evaluate the effectiveness of Ultrasound Visual Biofeed Therapy (U-VBF) in r-mediating speech disorders in children with a cleft palate.

Hypothesis (Study 1 and 2): After therapy, both treated words and untreated words have increased in accuracy relative to the baseline recording.

Ethics approval

NHS West of Scotland, 15/03/2017, ref: REC 1: 17/WS/0045

Study design

Study 1: Cross-sectional study
Study 2: Multiple baseline non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cleft lip and palate

Intervention

Study 1: Diagnostic Study
Participants take part in the research on the same day as attending one of their regular appointments at the Dental Hospital. They spend an extra 10 to 20 minutes of their appointment providing an ultrasound recording of their speech. This involves sitting in a small room with a speech and language therapist and having their tongue scanned with an ultrasound machine (placed under the chin) while they name some pictures and read some sentences.

Study 2: Intervention Study
Participants undergo the Ultrasound Visual Biofeedback Therapy to treat speech sound disorders. This treatment uses standard medical ultrasound to image the tongue and uses this as a a biofeedback tool for motor-based speech therapy.

The Ultrasound Visual Biofeedback Therapy uses standard medical ultrasound machine in tandem with a computer to record acoustics (speech) and articulation (tongue movement and lip moment from a camera) simultaneously. The ultrasound technique used is not physically invasive. For this particular study, participants sit next to an ultrasound scanner in a room. They need a stabilizing headset, which ensures that the ultrasound probe does not move too much once it is correctly positioned. The children are asked to read words, name pictures or imitate spoken words from a computer. They may be asked to drink a few sips of water during the recording, as this gives a fuller image of the inside of the mouth. They may also be recorded during unscripted spontaneous conversation.

In order to evaluate the effectiveness of ultrasound as a speech therapy tool, a qualified Speech & Language Therapist designs individual therapy plans for children using ultrasound. This study includes multiple baselines (x3), midtherapy, posttherapy and maintenance phases. Participants will receive 10 weekly sessions of ultrasound. Each session will last approximately one hour. The schedule is as follows:

Week 1: Baseline
Week 2: Baseline
Week 3: Baseline
Weeks 4 to 13: 10 sessions of therapy
Week 14: Maintenance Recording
Week 26: Follow up Maintenance Recording

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Study 1: Gibbon's eight error types in tongue shapes and tongue configuration is measured using the Dorsum Excursion Index and the Procrutes Index at the time of the study.

Study 2: Accuracy of speech production is measured using probe word lists and the Diagnostic Evaluation of Articulation and Phonology at each of the three baselines, immediately post-intervention and at 3 months post-intervention.

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/05/2016

Overall trial end date

31/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 3 to 15
2. Diagnosis of Cleft palate (and cleft lip)
3. Spoken English, at home or at school

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. No spoken English (at home or at school)
2. Evidence of severe/profound current hearing loss
3. Evidence of severe/profound learning disability

Recruitment start date

01/05/2017

Recruitment end date

31/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Dental Hospital and School
Glasgow Dental Hospital Sauchiehall Street
Glasgow
G2 3JZ
United Kingdom

Sponsor information

Organisation

University of Strathclyde

Sponsor details

16 Richmond Street
Glasgow
G1 1QE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Action Medical Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Joanne Cleland.
joanne.cleland@strath.ac.uk

Intention to publish date

30/04/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/08/2017: Ethics approval added.