Malocclusion Clinical Trial
Official title:
The Interdependence of Body Posture and the Stomatognathic System of School-age Children in Structural and Functional Terms
Verified date | March 2020 |
Source | University of Rzeszow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the study is to demonstrate a correlation between body posture and the structure and function of the stomatognathic system in school-age children.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | January 5, 2021 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: - age of study participant from 6 to 15 years of age - in case of an existing defect in body posture, lack of specific causes - in case of an existing malocclusion, lack of specific causes - in case of dysfunction of the stomatognathic system, lack of specific causes Exclusion Criteria: - congenital structural defects of the spine, - chronic diseases of the nervous system, - genetic diseases, - neuromuscular dystrophy, - endocrine disorder - an ongoing contagious disease - present locomotor fracture - current muscular injury |
Country | Name | City | State |
---|---|---|---|
Poland | University of Rzeszów | Rzeszów |
Lead Sponsor | Collaborator |
---|---|
University of Rzeszow |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical examination of the stomatognathic system (structural) | Assessment of occlusion by visual method according to Angle classification. Research Diagnostic Criteria of Functional Disorders of the Masticatory System. | at baseline, immediately after medical qualification to the study | |
Primary | Comprehensive body posture assessment | Static and dynamic body posture test using 4th Generation MORA which enables a detailed and spatial analysis of body posture by photogrammetric. | at baseline, immediately after medical qualification to the study | |
Primary | Clinical examination of the stomatognathic system (functional) | JMA+ Analyser (Jaw Motion Analyzer) system will allow to analyse movement and function of the temporomandibular joints, mandibular position, condyle position (EPA), and access the muscle action potentials through bipolar skin surface electrodes EMG. | at baseline, immediately after medical qualification to the study | |
Primary | Comprehensive body posture assessment | Next device used to to the body posture assessment will be KINEOD with pedobarograph which is a modern device for 3D analysis of body posture, in particular the back, but also lower limbs. The KINEOD system uses image acquisition technology with the aid of infrared. Therefore, it is a perfect complement to examining body posture using the so-called photogrammetric method, so-called moire projection method. | at baseline, immediately after medical qualification to the study | |
Secondary | Functional assessment of the spine and lower limbs | The assessment with the use of 3D device which is intertial sensor of movement. Its application in the scientific sphere allows the goniometric evaluation (range of movement) of the articulations. In the study it allows to assess the functional head and neck mobility and additionally in lumbar spine and lower limbs joints | at baseline, immediately after medical qualification to the study | |
Secondary | Anthropometric measurements | Seca 213 stadiometer - equipment necessary to examine the basic anthropometric measurements of height and weight. Waist and hip circumference will be measured by centimetre tape. | at baseline, immediately after medical qualification to the study | |
Secondary | Body mass composition analysis | Tanita MC 780 MA- segment body mass composition analyser using the bioimpedance method (BIA). The equipment has 8 electrodes for a detailed analysis with segment reading - the division of fat and muscle mass in the left and right arm, left and right leg and body, as well as between the leg muscularity index, segment index for fat tissue and muscle mass. | at baseline, immediately after medical qualification to the study | |
Secondary | Foot pressure | FreeMed Posture MAXI60 Pedobarograph will allow to access pressure fields acting between the plantar surface of the foot and a supporting surface. The device shows exactly degree of patient's foot presses on the ground. Additionally, it will allow testing the patient's equivalent responses. | at baseline, immediately after medical qualification to the study | |
Secondary | Body balance | FreeMed Posture MAXI60 Pedobarograph will allow to access pressure fields acting between the plantar surface of the foot and a supporting surface. The device shows exactly degree of patient's foot presses on the ground. Additionally, it will allow testing the patient's equivalent responses. | at baseline, immediately after medical qualification to the study | |
Secondary | 7-day physical activity | ActiGraph GT3X-BT accelerometers are currently the most accurate and objective motion sensors for assessing physical activity. The devices detect the acceleration of body movement in three planes, giving the possibility of reliable measurement of the intensity and duration of physical activity, as well as the number of steps performed and the time spent passively. Motion parameters are read thanks to a piezoelectric sensor. The subject will wear an accelerometer on his waist for an uninterrupted period of 7 days, excluding bathing time and swimming lessons. | at baseline, immediately after medical qualification to the study | |
Secondary | Blood pressure | Medel Connect Cardio MB 10 blood pressure monitor for measuring systolic and diastolic blood pressure, heartbeat values, and ECG. Each subject will have their blood pressure tested three times. | at baseline, immediately after medical qualification to the study |
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