RecruitingACTRN12622000417785

Evaluation and therapy of children in accordance with motor development and orofacial disorders

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


Sponsor

University of Health and Sport Sciences in Wroclaw

Enrollment

400 participants

Start Date

Feb 4, 2021

Study Type

Interventional

Conditions

Summary

Activation of the postural muscles and primal reflexes of the newborn during food intake, including the suckling reflex, began immediately after delivery. The qualitative aspects of spontaneous motor skills and the activities of the orofacial zone are related to the work of the whole body. The aim of this study is a quantitative and qualitative analysis of first spontaneous motor functions and auxiliary functions upright in an upright position and then locomotive functions allow identifying elements that have a significant impact on the qualitative aspect of psychomotor development. In the pediatric assessment, subjective scales for the assessment of spontaneous physical activity and muscle tone dominate, there is also little evidence of objective research showing how altering the quality and quantity of the motor pattern following therapeutic agents alters the motor function and how it affects food intake and motor pattern development.


Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 3 Yearss

Plain Language Summary

Simplified for easier understanding

How a baby moves and feeds in their earliest days of life gives important clues about their neurological development. For babies born prematurely, with Down syndrome, or at risk of cerebral palsy, early detection of movement difficulties can open the door to earlier therapy and better long-term outcomes. This Polish study closely observes and compares movement patterns, muscle tone, and feeding behaviours in newborns at neurological risk alongside healthy newborns. By understanding the links between early movement quality and orofacial function (the mouth and jaw area), researchers hope to develop better assessment tools and therapeutic approaches for infants who need support from the very earliest stages of life. This study involves babies from shortly after birth up to 3 years of age. The participant group includes babies born at 38–42 weeks gestation who are at risk due to prematurity, Down syndrome, or cerebral palsy risk, plus healthy newborns as a control group. Babies whose difficulties stem from birth trauma (such as shaken baby syndrome) or exposure to alcohol, smoking, or drugs during pregnancy are not eligible.

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Interventions

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 ef

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.


Locations(1)

Lower Silesia, Poland

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ACTRN12622000417785