Early Intervention
Conditions
Keywords
Risky Baby, Telerehabilitation, Family-centered approach, Early Intervention, Goal-directed physiotherapy
Brief summary
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.
Detailed description
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.
Interventions
OTHERTelerehabilitation
Family-centered, goal-oriented early physiotherapy approaches will be applied.
OTHERHome-based
Family-centered, goal-oriented early physiotherapy approaches will be applied.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* Babies born before \<37 weeks of gestation and treated in the neonatal intensive care unit * Infants with neurologic abnormalities (muscle hypertonia, hypotonia, hyperarousal, and abnormal general movements or cranial ultrasound abnormalities) at moderate to high risk of cerebral palsy * Babies referred to physiotherapy due to motor developmental delay and neurological dysfunction * Babies whose age range is between 0-12 months (corrected age will be calculated for premature babies) * Being diagnosed as a neurologically and developmentally risky baby * Babies who have completed their medical treatment and are not in neonatal intensive care * Babies of families who agreed to participate in the study and approved the informed consent form.
Exclusion criteria
* Babies with congenital cyanotic heart problems or cystic fibrosis * Babies with genetic disease or congenital anomaly * Infants on ventilator * Babies of families who do not accept to work * Babies of families who cannot come to the control * Families that cannot be contacted every week * Babies going to a special education and rehabilitation center
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAS Value at Day 90 | 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). |
| Bayley III - Cognitive | Day 0 | 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. |
| Bayley III - Cognitive Value at Day 30 | 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. |
| Bayley III - Cognitive Value at Day 60 | 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. |
| Bayley III - Cognitive Value at Day 90 | 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. |
| Bayley III - Language | Day 0 | 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. |
| Bayley III - Language Value at Day 30 | 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. |
| Bayley III - Language Value at Day 60 | 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. |
| Bayley III - Language Value at Day 90 | 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. |
| Bayley III - Motor | Day 0 | 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. |
| Bayley III - Motor Value at Day 30 | 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. |
| Bayley III - Motor Value at Day 60 | 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. |
| Bayley III - Motor Value at Day 90 | 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. |
| Hammersmith Infant Neurological Examination (HINE) | Day 0 | 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. |
| HINE Value at Day 30 | 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. |
| HINE Value at Day 60 | 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. |
| HINE Value at Day 90 | 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. |
| Goal Attainment Scale (GAS) | Day 0 | 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). |
| GAS Value at Day 30 | 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). |
| GAS Value at Day 60 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Telerehabilitation Satisfication Survey | Day 90 | This questionnaire was developed by the researchers to assess parental satisfaction with the telerehabilitation process. It includes 8 items focusing on perceived effectiveness, convenience, communication quality, and technical usability of the sessions. Scale: Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total Score Range: 8 (minimum satisfaction) to 40 (maximum satisfaction). Scoring: The total satisfaction score is obtained by summing the scores of all 8 items. Higher scores indicate greater satisfaction with the telerehabilitation experience. There are no subscales and no reverse-scored items. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Informed consent was obtained, and 26 infants and 26 mothers who presented to the high-risk infant clinic at Marmara University Hospital between 2022 and 2023 were included in the study.
Pre-assignment details
After obtaining informed consent from the parents, 26 infants and 26 mothers were randomized into groups and assessments were conducted. However, a total of 2 infants and 2 mothers, one from each group, did not attend the follow-up evaluations at the hospital one month later, and thus were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Telerehabilitation - Infants A telerehabilitation-based exercise group where the therapist coaches the family, performs one-on-one exercises with families with a doll in his hand, and can perform the necessary interventions such as promoting good practices and preventing bad practices, and the other 2 days where the families show their exercises by sending videos to the therapist, and again provide the therapist's intervention and follow-up via videos
Telerehabilitation: Family-centered, goal-oriented early physiotherapy approaches will be applied. | 13 |
| Home-based - Infants The home-based group that will be given exercise training at the beginning of treatment and at 4., 8., and 12. week.
Home-based: Family-centered, goal-oriented early physiotherapy approaches will be applied. | 13 |
| Telerehabilitation -Mothers Mothers exercising in the telerehabilitation group | 13 |
| Home-based - Mothers Mothers exercising in the control group | 13 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study - Infants | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Telerehabilitation - Infants | Home-based - Infants | Telerehabilitation -Mothers | Home-based - Mothers | Total |
|---|---|---|---|---|---|
| Age, Continuous | 0.54 years STANDARD_DEVIATION 0.06 | 0.58 years STANDARD_DEVIATION 0.07 | 28.85 years STANDARD_DEVIATION 4.67 | 32.77 years STANDARD_DEVIATION 5.29 | 15.68 years STANDARD_DEVIATION 2.52 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants | 13 Participants | 39 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 0 Participants | 0 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Cognitive | 77.69 score on a scale | Standard Deviation 15.22 |
| Home-based | Bayley III - Cognitive | 78.46 score on a scale | Standard Deviation 14.19 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Cognitive Value at Day 30 | 82.08 score on a scale | Standard Deviation 11.76 |
| Home-based | Bayley III - Cognitive Value at Day 30 | 77.08 score on a scale | Standard Deviation 10.1 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Cognitive Value at Day 60 | 84.58 score on a scale | Standard Deviation 10.32 |
| Home-based | Bayley III - Cognitive Value at Day 60 | 73.33 score on a scale | Standard Deviation 12.67 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Cognitive Value at Day 90 | 89.17 score on a scale | Standard Deviation 7.63 |
| Home-based | Bayley III - Cognitive Value at Day 90 | 82.08 score on a scale | Standard Deviation 8.64 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Language | 77.85 score on a scale | Standard Deviation 10.76 |
| Home-based | Bayley III - Language | 83.38 score on a scale | Standard Deviation 7.27 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Language Value at Day 30 | 85.17 score on a scale | Standard Deviation 7.86 |
| Home-based | Bayley III - Language Value at Day 30 | 85.42 score on a scale | Standard Deviation 4.92 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Language Value at Day 60 | 84.83 score on a scale | Standard Deviation 5.25 |
| Home-based | Bayley III - Language Value at Day 60 | 82.75 score on a scale | Standard Deviation 4.39 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Language Value at Day 90 | 89.92 score on a scale | Standard Deviation 2.81 |
| Home-based | Bayley III - Language Value at Day 90 | 87.00 score on a scale | Standard Deviation 5.76 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Motor | 81.08 score on a scale | Standard Deviation 13.49 |
| Home-based | Bayley III - Motor | 88.54 score on a scale | Standard Deviation 11.14 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Motor Value at Day 30 | 92.33 score on a scale | Standard Deviation 12.07 |
| Home-based | Bayley III - Motor Value at Day 30 | 88.08 score on a scale | Standard Deviation 9.99 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Motor Value at Day 60 | 89.00 score on a scale | Standard Deviation 9.42 |
| Home-based | Bayley III - Motor Value at Day 60 | 81.50 score on a scale | Standard Deviation 8.93 |
Primary
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
Population: Risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Bayley III - Motor Value at Day 90 | 101.33 score on a scale | Standard Deviation 5.86 |
| Home-based | Bayley III - Motor Value at Day 90 | 95.08 score on a scale | Standard Deviation 6.72 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | GAS Value at Day 30 | -0.42 score on a scale | Standard Deviation 1.37 |
| Home-based | GAS Value at Day 30 | -1.25 score on a scale | Standard Deviation 0.96 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | GAS Value at Day 60 | -0.33 score on a scale | Standard Deviation 0.88 |
| Home-based | GAS Value at Day 60 | -1.25 score on a scale | Standard Deviation 0.75 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | GAS Value at Day 90 | 0.50 score on a scale | Standard Deviation 0.9 |
| Home-based | GAS Value at Day 90 | -0.50 score on a scale | Standard Deviation 0.67 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Goal Attainment Scale (GAS) | -1.62 score on a scale | Standard Deviation 0.76 |
| Home-based | Goal Attainment Scale (GAS) | -0.85 score on a scale | Standard Deviation 1.06 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Hammersmith Infant Neurological Examination (HINE) | 51.92 score on a scale | Standard Deviation 7.22 |
| Home-based | Hammersmith Infant Neurological Examination (HINE) | 50.15 score on a scale | Standard Deviation 7.09 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | HINE Value at Day 30 | 58.08 score on a scale | Standard Deviation 7.09 |
| Home-based | HINE Value at Day 30 | 55.50 score on a scale | Standard Deviation 6.08 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | HINE Value at Day 60 | 66.50 score on a scale | Standard Deviation 4.6 |
| Home-based | HINE Value at Day 60 | 61.92 score on a scale | Standard Deviation 6.14 |
Primary
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
Population: risky babies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | HINE Value at Day 90 | 74.00 score on a scale | Standard Deviation 3.24 |
| Home-based | HINE Value at Day 90 | 68.92 score on a scale | Standard Deviation 6.59 |
Other Pre-specified
Telerehabilitation Satisfication Survey
This questionnaire was developed by the researchers to assess parental satisfaction with the telerehabilitation process. It includes 8 items focusing on perceived effectiveness, convenience, communication quality, and technical usability of the sessions. Scale: Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total Score Range: 8 (minimum satisfaction) to 40 (maximum satisfaction). Scoring: The total satisfaction score is obtained by summing the scores of all 8 items. Higher scores indicate greater satisfaction with the telerehabilitation experience. There are no subscales and no reverse-scored items.
Time frame: Day 90
Population: Mothers of risky babies
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telerehabilitation | Telerehabilitation Satisfication Survey | 40 score on a scale |
| Home-based | Telerehabilitation Satisfication Survey | 35.5 score on a scale |