While the mortality rate in preterm births has decreased thanks to recent developments in the field of medicine, disability risk factors increase for premature babies. Premature birth, low birth weight, and all accompanying problems in this process reveal the concept of the risky baby. Early intervention is very important for these babies who are at risk for neurodevelopmental problems. Although early intervention is a general concept, the subject the investigators focus on is early physiotherapy approaches. Early physiotherapy approaches include many methods. However, recently, family-centered approaches have been emphasized and studies have been carried out on this issue; Likewise, the goal-oriented therapy approach, which is a treatment with a high level of evidence, is also being investigated. Telerehabilitation, on the other hand, has become a method that is frequently used with the increase in the use of technological methods. The effectiveness of family-centered, goal-oriented physiotherapy approaches is known in previous studies on this subject; There are studies conducted on a remotely monitored portable intelligent system created for telerehabilitation, but no studies have been found in which telerehabilitation has been applied using the real-time video conferencing method.
Babies in whom negative biological and environmental factors cause neuromotor developmental problems are defined as "risk babies". Risky babies are classified differently. This classification; may be according to gestational age, birth weight, and pathophysiological problems. Especially, premature babies born at 32 weeks and under 1500 g, babies with periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, and intrauterine growth retardation are in the high-risk group. The mortality rate in risky babies has decreased considerably in recent years, but with this decrease, neurodevelopmental disorders including motor problems, incoordination, cognitive impairment, attention problems, or developmental problems are seen in these babies who live prematurely, and the risk of Cerebral Palsy (CP) occurs. CP is the common name of a group of non-progressive permanent disorders that primarily lead to impairment in movement and posture development and activity limitation, and that can also be seen in addition to sensory and cognitive problems, due to permanent damage to the developing brain. The primary condition for early intervention is to identify babies who may have CP. Early detection may be beneficial for the initiation of early intervention in the period when neuroplasticity is high. Based on neuroplasticity knowledge, it is thought that it will be beneficial for risky babies during development, and it may be possible to prevent neurodevelopmental problems and permanent disabilities, with early intervention and protective approaches. In general, the early intervention approach includes supporting the development of babies who are at risk for developmental delay or disability by providing the necessary support, treatment, and training, starting from the neonatal period and up to 24 months. Early intervention methods have many components and require a multidisciplinary approach. Methods can focus on different approaches according to the determined goals. Physiotherapy and rehabilitation approaches are of great importance in supporting the development and improving functional outcomes in early intervention. It is aimed to provide normal sensory input and gain normal functional movements by using the rapid learning ability originating from brain plasticity, and to reach the most independent level that the child can reach in terms of physical, cognitive, and psychosocial aspects within the anatomical and physiological deficiencies and environmental limitations. There are many early physiotherapy and rehabilitation approaches that focus on motor development and normalization. Goal-oriented therapy; is known as an approach that facilitates the participation and adaptation of infants and children with motor developmental delay to daily life activities. Goal-oriented neuromotor therapy approach; It is a set of movements organized around a functional goal and the environment enables the movement to occur. Studies on rehabilitation have recently focused on treatment approaches that focus on functionality in accordance with the "Activity and Participation" area of ICF. It is known that babies also have levels of functionality that enable them to participate in activities of daily living. In a study in which goal-oriented neuromotor therapy was applied in early rehabilitation applications, it was stated that this approach could be applied by both the physiotherapist and the family under the control of the physiotherapist. Family-centered physiotherapy applications have come to the fore in recent years, it is the treatment approach that focuses on the environment and what the child can do and practiced by family. Motor reactions are activated by providing normal sensory input. Telerehabilitation is the delivery of rehabilitation services by computer-based technologies and communication tools by rehabilitation specialists. It is an emerging method that provides rehabilitation services by reducing time, distance, and cost barriers and using technological tools. Although the importance of early physiotherapy approaches is known today, when the literature is examined, it is seen that the number of studies is insufficient and a consensus has not yet been reached on which therapy approach is more successful. No study has been found in which family education of risky infants was followed up with telerehabilitation before.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
26
Family-centered, goal-oriented early physiotherapy approaches will be applied.
Family-centered, goal-oriented early physiotherapy approaches will be applied.
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)
Bayley III - Cognitive
Cognitive development of infants will be evaluated. Standard Scores: The Cognitive Scale produces standard scores with a mean of 100 and a standard deviation of 15. Scores are typically categorized as follows: Above Average: \>115 Average: 85-115 Below Average: \<85 T-Scores: T-scores, commonly used in research, are derived with a mean of 50 and a standard deviation of 10. These scores are useful for comparing an individual's performance to normative data. Minimum and Maximum Scores: The floor score for the Cognitive domain in Bayley-III is 55, while the ceiling score is 145. These scores represent extreme levels of performance relative to the normative sample. Higher or Lower Scores: Higher Scores: Indicate better cognitive functioning or developmental progress. Lower Scores: Suggest potential delays or impairments in cognitive development.
Time frame: Day 0
Bayley III - Cognitive Value at Day 30
Cognitive development of infants will be evaluated. Standard Scores: The Cognitive Scale produces standard scores with a mean of 100 and a standard deviation of 15. Scores are typically categorized as follows: Above Average: \>115 Average: 85-115 Below Average: \<85 T-Scores: T-scores, commonly used in research, are derived with a mean of 50 and a standard deviation of 10. These scores are useful for comparing an individual's performance to normative data. Minimum and Maximum Scores: The floor score for the Cognitive domain in Bayley-III is 55, while the ceiling score is 145. These scores represent extreme levels of performance relative to the normative sample. Higher or Lower Scores: Higher Scores: Indicate better cognitive functioning or developmental progress. Lower Scores: Suggest potential delays or impairments in cognitive development.
Time frame: Day 30
Bayley III - Cognitive Value at Day 60
Cognitive development of infants will be evaluated. Standard Scores: The Cognitive Scale produces standard scores with a mean of 100 and a standard deviation of 15. Scores are typically categorized as follows: Above Average: \>115 Average: 85-115 Below Average: \<85 T-Scores: T-scores, commonly used in research, are derived with a mean of 50 and a standard deviation of 10. These scores are useful for comparing an individual's performance to normative data. Minimum and Maximum Scores: The floor score for the Cognitive domain in Bayley-III is 55, while the ceiling score is 145. These scores represent extreme levels of performance relative to the normative sample. Higher or Lower Scores: Higher Scores: Indicate better cognitive functioning or developmental progress. Lower Scores: Suggest potential delays or impairments in cognitive development.
Time frame: Day 60
Bayley III - Cognitive Value at Day 90
Cognitive development of infants will be evaluated. Standard Scores: The Cognitive Scale produces standard scores with a mean of 100 and a standard deviation of 15. Scores are typically categorized as follows: Above Average: \>115 Average: 85-115 Below Average: \<85 T-Scores: T-scores, commonly used in research, are derived with a mean of 50 and a standard deviation of 10. These scores are useful for comparing an individual's performance to normative data. Minimum and Maximum Scores: The floor score for the Cognitive domain in Bayley-III is 55, while the ceiling score is 145. These scores represent extreme levels of performance relative to the normative sample. Higher or Lower Scores: Higher Scores: Indicate better cognitive functioning or developmental progress. Lower Scores: Suggest potential delays or impairments in cognitive development.
Time frame: Day 90
Bayley III - Language
Receptive Language: Measures how well a child understands spoken language and can respond to it. Expressive Language: Measures a child's ability to use words and sentences to communicate. Standard Scores: Like the Cognitive Scale, the Language subscale uses a mean of 100 and a standard deviation of 15. A typical distribution includes: Above Average: Scores above 115 Average: Scores between 85 and 115 Below Average: Scores below 85 The minimum score on the Bayley-III Language scale is 55, while the maximum is 145. Higher Scores: Indicate better language development and a stronger ability to understand and express language. Lower Scores: Suggest potential delays in language development, which may require further evaluation or intervention. T-Scores: The T-score for the Bayley-III Language scale is often used in research settings to compare an individual's performance against a larger population. Like standard scores, the mean is 50 and the standard deviation is 10.
Time frame: Day 0
Bayley III - Language Value at Day 30
Receptive Language: Measures how well a child understands spoken language and can respond to it. Expressive Language: Measures a child's ability to use words and sentences to communicate. Standard Scores: Like the Cognitive Scale, the Language subscale uses a mean of 100 and a standard deviation of 15. A typical distribution includes: Above Average: Scores above 115 Average: Scores between 85 and 115 Below Average: Scores below 85 The minimum score on the Bayley-III Language scale is 55, while the maximum is 145. Higher Scores: Indicate better language development and a stronger ability to understand and express language. Lower Scores: Suggest potential delays in language development, which may require further evaluation or intervention. T-Scores: The T-score for the Bayley-III Language scale is often used in research settings to compare an individual's performance against a larger population. Like standard scores, the mean is 50 and the standard deviation is 10.
Time frame: Day 30
Bayley III - Language Value at Day 60
Receptive Language: Measures how well a child understands spoken language and can respond to it. Expressive Language: Measures a child's ability to use words and sentences to communicate. Standard Scores: Like the Cognitive Scale, the Language subscale uses a mean of 100 and a standard deviation of 15. A typical distribution includes: Above Average: Scores above 115 Average: Scores between 85 and 115 Below Average: Scores below 85 The minimum score on the Bayley-III Language scale is 55, while the maximum is 145. Higher Scores: Indicate better language development and a stronger ability to understand and express language. Lower Scores: Suggest potential delays in language development, which may require further evaluation or intervention. T-Scores: The T-score for the Bayley-III Language scale is often used in research settings to compare an individual's performance against a larger population. Like standard scores, the mean is 50 and the standard deviation is 10.
Time frame: Day 60
Bayley III - Language Value at Day 90
Receptive Language: Measures how well a child understands spoken language and can respond to it. Expressive Language: Measures a child's ability to use words and sentences to communicate. Standard Scores: Like the Cognitive Scale, the Language subscale uses a mean of 100 and a standard deviation of 15. A typical distribution includes: Above Average: Scores above 115 Average: Scores between 85 and 115 Below Average: Scores below 85 The minimum score on the Bayley-III Language scale is 55, while the maximum is 145. Higher Scores: Indicate better language development and a stronger ability to understand and express language. Lower Scores: Suggest potential delays in language development, which may require further evaluation or intervention. T-Scores: The T-score for the Bayley-III Language scale is often used in research settings to compare an individual's performance against a larger population. Like standard scores, the mean is 50 and the standard deviation is 10.
Time frame: Day 90
Bayley III - Motor
Gross Motor: Assesses abilities related to large muscle groups. Fine Motor: Measures small muscle control. Standard Scores: The motor scale uses a mean of 100 and a standard deviation of 15, consistent with the Cognitive and Language scales. Above Average: Scores above 115. Average: Scores between 85 and 115. Below Average: Scores below 85. The minimum score on the Bayley-III Motor scale is 55, while the maximum is 145. T-Scores: The T-score is calculated using a mean of 50 and a standard deviation of 10, commonly used in research to compare an individual's performance with a larger population. Higher Scores: Indicate more advanced motor development, with better coordination and movement abilities. Lower Scores: Suggest potential delays in motor development, which may require intervention or further assessment.
Time frame: Day 0
Bayley III - Motor Value at Day 30
Gross Motor: Assesses abilities related to large muscle groups. Fine Motor: Measures small muscle control. Standard Scores: The motor scale uses a mean of 100 and a standard deviation of 15, consistent with the Cognitive and Language scales. Above Average: Scores above 115. Average: Scores between 85 and 115. Below Average: Scores below 85. The minimum score on the Bayley-III Motor scale is 55, while the maximum is 145. T-Scores: The T-score is calculated using a mean of 50 and a standard deviation of 10, commonly used in research to compare an individual's performance with a larger population. Higher Scores: Indicate more advanced motor development, with better coordination and movement abilities. Lower Scores: Suggest potential delays in motor development, which may require intervention or further assessment.
Time frame: Day 30
Bayley III - Motor Value at Day 60
Gross Motor: Assesses abilities related to large muscle groups. Fine Motor: Measures small muscle control. Standard Scores: The motor scale uses a mean of 100 and a standard deviation of 15, consistent with the Cognitive and Language scales. Above Average: Scores above 115. Average: Scores between 85 and 115. Below Average: Scores below 85. The minimum score on the Bayley-III Motor scale is 55, while the maximum is 145. T-Scores: The T-score is calculated using a mean of 50 and a standard deviation of 10, commonly used in research to compare an individual's performance with a larger population. Higher Scores: Indicate more advanced motor development, with better coordination and movement abilities. Lower Scores: Suggest potential delays in motor development, which may require intervention or further assessment.
Time frame: Day 60
Bayley III - Motor Value at Day 90
Gross Motor: Assesses abilities related to large muscle groups. Fine Motor: Measures small muscle control. Standard Scores: The motor scale uses a mean of 100 and a standard deviation of 15, consistent with the Cognitive and Language scales. Above Average: Scores above 115. Average: Scores between 85 and 115. Below Average: Scores below 85. The minimum score on the Bayley-III Motor scale is 55, while the maximum is 145. T-Scores: The T-score is calculated using a mean of 50 and a standard deviation of 10, commonly used in research to compare an individual's performance with a larger population. Higher Scores: Indicate more advanced motor development, with better coordination and movement abilities. Lower Scores: Suggest potential delays in motor development, which may require intervention or further assessment.
Time frame: Day 90
Hammersmith Infant Neurological Examination (HINE)
The total score is then calculated by summing the scores for all the items. A higher total score indicates more typical neurological development, while a lower score may indicate delays or neurological abnormalities. The HINE is divided in 3 sections. Section 1 (neurologic examination) consists of 26 items assessing cranial nerve function, posture, movements, tone, and reflexes and reactions, and the items are scored 0-3 points in 0.5-point steps with a maximum total score of 78. Interpretation: Normal: A total score of ≥57 generally indicates normal neurological function. Mild Abnormalities: Scores 46-56 suggest mild motor or neurological delays. Severe Abnormalities: Scores \<45 are indicative of significant neurological concerns.
Time frame: Day 0
HINE Value at Day 30
The total score is then calculated by summing the scores for all the items. A higher total score indicates more typical neurological development, while a lower score may indicate delays or neurological abnormalities. The HINE is divided in 3 sections. Section 1 (neurologic examination) consists of 26 items assessing cranial nerve function, posture, movements, tone, and reflexes and reactions, and the items are scored 0-3 points in 0.5-point steps with a maximum total score of 78. Interpretation: Normal: A total score of ≥57 generally indicates normal neurological function. Mild Abnormalities: Scores 46-56 suggest mild motor or neurological delays. Severe Abnormalities: Scores \<45 are indicative of significant neurological concerns.
Time frame: Day 30
HINE Value at Day 60
The total score is then calculated by summing the scores for all the items. A higher total score indicates more typical neurological development, while a lower score may indicate delays or neurological abnormalities. The HINE is divided in 3 sections. Section 1 (neurologic examination) consists of 26 items assessing cranial nerve function, posture, movements, tone, and reflexes and reactions, and the items are scored 0-3 points in 0.5-point steps with a maximum total score of 78. Interpretation: Normal: A total score of ≥57 generally indicates normal neurological function. Mild Abnormalities: Scores 46-56 suggest mild motor or neurological delays. Severe Abnormalities: Scores \<45 are indicative of significant neurological concerns.
Time frame: Day 60
HINE Value at Day 90
The total score is then calculated by summing the scores for all the items. A higher total score indicates more typical neurological development, while a lower score may indicate delays or neurological abnormalities. The HINE is divided in 3 sections. Section 1 (neurologic examination) consists of 26 items assessing cranial nerve function, posture, movements, tone, and reflexes and reactions, and the items are scored 0-3 points in 0.5-point steps with a maximum total score of 78. Interpretation: Normal: A total score of ≥57 generally indicates normal neurological function. Mild Abnormalities: Scores 46-56 suggest mild motor or neurological delays. Severe Abnormalities: Scores \<45 are indicative of significant neurological concerns.
Time frame: Day 90
Goal Attainment Scale (GAS)
Goal Attainment Scaling (GAS) allows clinicians or educators to establish specific, individualized goals for a patient or student. These goals are tailored to the individual's needs and context and are evaluated using a 5-point ordinal scale that includes both positive and negative values: The 5-point scale includes: "plus two" (much better than expected), "plus one" (slightly better than expected), "zero" (expected outcome), "minus one" (slightly worse than expected), and "minus two" (much worse than expected).
Time frame: Day 0
GAS Value at Day 30
Goal Attainment Scaling (GAS) allows clinicians or educators to establish specific, individualized goals for a patient or student. These goals are tailored to the individual's needs and context and are evaluated using a 5-point ordinal scale that includes both positive and negative values: The 5-point scale includes: "plus two" (much better than expected), "plus one" (slightly better than expected), "zero" (expected outcome), "minus one" (slightly worse than expected), and "minus two" (much worse than expected).
Time frame: Day 30
GAS Value at Day 60
Goal Attainment Scaling (GAS) allows clinicians or educators to establish specific, individualized goals for a patient or student. These goals are tailored to the individual's needs and context and are evaluated using a 5-point ordinal scale that includes both positive and negative values: The 5-point scale includes: "plus two" (much better than expected), "plus one" (slightly better than expected), "zero" (expected outcome), "minus one" (slightly worse than expected), and "minus two" (much worse than expected).
Time frame: Day 60
GAS Value at Day 90
Goal Attainment Scaling (GAS) allows clinicians or educators to establish specific, individualized goals for a patient or student. These goals are tailored to the individual's needs and context and are evaluated using a 5-point ordinal scale that includes both positive and negative values: The 5-point scale includes: "plus two" (much better than expected), "plus one" (slightly better than expected), "zero" (expected outcome), "minus one" (slightly worse than expected), and "minus two" (much worse than expected).
Time frame: Day 90
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