ANZCTR - Registration

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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]

‘Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

motor development

ankyloglossia

breastfeeding difficulties

psychomotor development

Condition category

Condition code

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Reproductive Health and Childbirth

Breast feeding

Reproductive Health and Childbirth

Complications of newborn

Musculoskeletal

Other muscular and skeletal disorders

Neurological

Other neurological disorders

Human Genetics and Inherited Disorders

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]

Early detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

Healthy children aged 0 - 3 years

Control group

Active

Outcomes

Primary outcome [1]

Viscoelasticity of muscle assessed using the Myoton PRO.

Timepoint [1]

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]

Muscle tone assessed using surface electromyography.

Timepoint [2]

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]

Body surface temperature assessed using thermography.

Timepoint [3]

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]

Oxygen saturation assessed using pulse oximetry.

Timepoint [1]