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Trial registered on ANZCTR


Registration number
ACTRN12622000417785
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
11/03/2022
Date last updated
25/04/2024
Date data sharing statement initially provided
11/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation and therapy of children in accordance with motor development and orofacial disorders
Scientific title
Evaluation and therapy of patients with qualitative motor pattern disorders of varying severity in terms of ankyloglossia and psychomotor development in the first three years of life
Secondary ID [1] 306274 0
‘Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
motor development 325029 0
ankyloglossia 325030 0
breastfeeding difficulties 325032 0
psychomotor development 325033 0
Condition category
Condition code
Musculoskeletal 322465 322465 0 0
Normal musculoskeletal and cartilage development and function
Reproductive Health and Childbirth 322466 322466 0 0
Breast feeding
Reproductive Health and Childbirth 322580 322580 0 0
Complications of newborn
Musculoskeletal 322581 322581 0 0
Other muscular and skeletal disorders
Neurological 322582 322582 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 322583 322583 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Babies will undergo a medical evaluation during the first few days (1-3) of life as a face-to-face attendance at a paediatric clinic. This will include a physical examination, assessment of sucking efficiency using the sucking skills assessment protocol (Martinelli, CNOL), anatomical assessment of the sublingual frenulum according to Kotlow, and organ assessment using ultrasound. Observation sessions will take approximately 2 hours to complete, and will be conducted at 1-3 days of life, then every 6-7 weeks up to 1 year of life, and then every 6 months up until 3 years of age. Children will undergo spontaneous motor activity assessment according to Vojta, thermal imaging, myotonometry, pulse oximetry, electromyography.
Assessment and therapy of spontaneous motor skills according to Vojta will be conducted by a certified therapist. All assessments will be repeated at each follow-up visit. And each assessment will be performed by pediatrician, neonatologist, physiotherapist, speech therapist.
Thermal evaluation will be conducted using a thermal imaging camera. Thermography is a medical imaging modality. It is a completely safe, non-invasive, and non-contact method to determine the distribution of body surface temperatures, which is often associated with physiological or pathological tissue or organ conditions. Non-contact thermography provides support for traditional screening methods. Because of its ability to analyze the temperature distribution of the body surface, thermography can be considered as a complementary method in the diagnosis of muscle activity in newborn infants and children. The test will consist of taking a series of pictures without physical contact with the child.
Myotonometric evaluation using the MyotonPRO device to measure viscoelastic parameters uses the superficial deformation of soft tissues caused by a mechanical pulse. Based on the phenomenon of mechanical damping, MyotonPRO measures three basic parameters: stiffness (expressed in N/m), resting tension (defined by the oscillation frequency expressed in Hz) and tissue elasticity (represented by the logarithmic oscillation slope). A mechanical impulse causing pressure on the skin surface over the examined muscle or tendon is generated using a small probe placed in the lower part of the device. The said probe also records the tissue response in the form of vibrations. The measurement result is then displayed on the screen within a few seconds. The values of the aforementioned parameters are estimated from the oscillation curve of the vibration.
Pulse oximetry assessment - a non-invasive method of transcutaneous determination of blood oxygen saturation. The method is based on the principle of spectrophotometric measurement of oxygen saturation (saturation - SpO2) of hemoglobin.
Surface electromyography will assess muscle tone. The test will involve sticking surface electrodes to the skin over the muscle belly under study and recording the signal during movement and at rest.
The participant group of interest is babies at risk of cerebral palsy, Down syndrome, or who were born prematurely.
Whether participants have received an examination by a speech therapist or any orofacial therapy will also be assessed by accessing patient electronic medical records, with no additional involvement by the participant required.
The therapeutic effect, depending on the patient's needs, will be based on the technique of lying on the tummy, feeding in a biological position, using the Vojta method of stimulation and performing massage of the orofacial zone and the whole body.
Duration and frequency: 5-6 times a day 3-5 minutes. Duration and frequency will be changing with the possibilities of a child.
Administration of therapy: leading physiotherapist.
Adherence to correct techniques and therapy sessions will be assessed based on direct observation, observation of photo and short movies made at home.

Intervention code [1] 322701 0
Early detection / Screening
Intervention code [2] 322702 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy children aged 0 - 3 years
Control group
Active

Outcomes
Primary outcome [1] 330246 0
Viscoelasticity of muscle assessed using the Myoton PRO.
Timepoint [1] 330246 0
At days 1-3 of life, then every 6 weeks until 1 year of life (primary endpoint), then every 6 months until 3 years of life.
Primary outcome [2] 330247 0
Muscle tone assessed using surface electromyography.
Timepoint [2] 330247 0
At days 1-3 of life, then every 6 weeks until 1 year of life (primary endpoint), then every 6 months until 3 years of life,
Primary outcome [3] 330248 0
Body surface temperature assessed using thermography.
Timepoint [3] 330248 0
At days 1-3 of life, then every 6 weeks until 1 year of life (primary endpoint), then every 6 months until 3 years of life,
Secondary outcome [1] 405459 0
Oxygen saturation assessed using pulse oximetry.
Timepoint [1] 405459 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,
Secondary outcome [2] 405460 0
Motor development assessed using the Vojta method.
Timepoint [2] 405460 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,
Secondary outcome [3] 405461 0
Assessment of suction efficiency using the Suction Assessment Protocol (Martinelli, Suction Assessment Protocol by Center for Lactation Science),
Timepoint [3] 405461 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,
Secondary outcome [4] 405462 0
Speach therapist examination. - Tongue movements,
Tongue movements, the way of eating (sucking and then translating food - tongue work), This is a composite outcome
Timepoint [4] 405462 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,
Secondary outcome [5] 406026 0
Motor development assessed using the American Associated of Pediatric.
Timepoint [5] 406026 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,
Secondary outcome [6] 406027 0
Anatomical assessment of the sublingual frenulum according to Kotlow, and organ assessment using ultrasound.
Timepoint [6] 406027 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,
Secondary outcome [7] 406615 0
Speach therapist examination. - Tongue movements
The correctness of speaking, the possibility of using the facial muscles (oral zone and adjacent parts).
Timepoint [7] 406615 0
At days 1-3 of life, then every 6 weeks until 1 year of life, then every 6 months until 3 years of life,

Eligibility
Key inclusion criteria
Participant group: babies risk of cerebral palsy, Down Syndrome, prematurely born, and newborn from physiological pregnancies, between 38 and 42 weeks of gestation, with Apgar scores of 8-10 points.
Control group: Healthy babies.
Minimum age
1 Days
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children at risk for neurological damage resulting from mechanical birth injuries (e.g., shaken baby syndrome) or pregnancies disrupted by fetal chemical abuse (alcohol, smoking, drugs).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
400
Accrual to date
80
Final
Recruitment outside Australia
Country [1] 24525 0
Poland
State/province [1] 24525 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 310623 0
Government body
Name [1] 310623 0
National Science Center
Country [1] 310623 0
Poland
Funding source category [2] 310624 0
University
Name [2] 310624 0
University of Health and Sport Sciences in Wroclaw
Country [2] 310624 0
Poland
Primary sponsor type
University
Name
University of Health and Sport Sciences in Wroclaw
Address
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country
Poland
Secondary sponsor category [1] 311947 0
None
Name [1] 311947 0
Address [1] 311947 0
Country [1] 311947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310228 0
Senate Committee on Research Ethics at the Wroclaw University of Health and Sport Sciences
Ethics committee address [1] 310228 0
Ethics committee country [1] 310228 0
Poland
Date submitted for ethics approval [1] 310228 0
29/01/2021
Approval date [1] 310228 0
04/02/2021
Ethics approval number [1] 310228 0
24/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116922 0
Dr Agnieszka Ptak
Address 116922 0
Agnieszka Ptak
Wroclaw University of Health and Sport Science
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country 116922 0
Poland
Phone 116922 0
+48 71 3473046
Fax 116922 0
Email 116922 0
agnieszka.ptak@awf.wroc.pl
Contact person for public queries
Name 116923 0
Agnieszka Ptak
Address 116923 0
Agnieszka Ptak
Wroclaw University of Health and Sport Science
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country 116923 0
Poland
Phone 116923 0
+48 71 3473046
Fax 116923 0
Email 116923 0
agnieszka.ptak@awf.wroc.pl
Contact person for scientific queries
Name 116924 0
Agnieszka Ptak
Address 116924 0
Agnieszka Ptak
Wroclaw University of Health and Sport Science
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country 116924 0
Poland
Phone 116924 0
+48 71 3473046
Fax 116924 0
Email 116924 0
agnieszka.ptak@awf.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data won't be shared. Data analysis will be only published as a statistical summary.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessment of Viscoelastic Parameters of Muscles in Children Aged 4-9 Months with Minor Qualitative Impairment of the Motor Pattern after Vojta Therapy Implementation.2022https://dx.doi.org/10.3390/ijerph191610448
N.B. These documents automatically identified may not have been verified by the study sponsor.