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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | Mothers attended monthly exercise sessions at the hospital and engaged in home exercises for 45 minutes, twice weekly. They communicated their progress via messaging. Moreover, a 45-minute physiotherapy session was held weekly through live video conferencing, during which the physiotherapist guided and observed the mother while she interacted with a simulated infant model. |
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| Home-based | Other | Mothers underwent monthly exercise sessions at the hospital and engaged in home exercises lasting 45 minutes, thrice weekly. They documented their exercise routines on a weekly chart and discussed them with the physiotherapist during their monthly hospital appointments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Other | Family-centered, goal-oriented early physiotherapy approaches will be applied. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayca Evkaya Acar, MSc | Istanbul Medeniyet University | Principal Investigator |
| Esra Pehlivan, Assoc. Prof. | Saglik Bilimleri University | Study Director |
| Evrim Karadag Saygi, Prof. | Marmara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Pendik Training and Research Hospital | Istanbul | 34899 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27571484 | Background | Asztalos EV, Church PT, Riley P, Fajardo C, Shah PS; Canadian Neonatal Network and Canadian Neonatal Follow-up Network Investigators. Association between Primary Caregiver Education and Cognitive and Language Development of Preterm Neonates. Am J Perinatol. 2017 Mar;34(4):364-371. doi: 10.1055/s-0036-1592080. Epub 2016 Aug 29. | |
| 21241364 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telerehabilitation | 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. |
| FG001 | Control (Home-based Group) | The Home-based group that will be given exercise training at the beginning of treatment and at 4., 8., and 12. week. Control: Family-centered, goal-oriented early physiotherapy approaches will be applied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study - Infants |
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| Overall Study - Mothers |
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Risky babies with corrected ages ranging from 0-12 months and their mothers who applied to Risky Baby Polyclinic and babies who met the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
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Measured at 12 weeks post-baseline (Week 12 of intervention.)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telerehabilitation | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ayca Evkaya Acar | Istanbul Medeniyet University | +905544263263 | ayca.evkaya@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2021 | May 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| D018575 | Home Care Services, Hospital-Based |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Home-based | Other | Family-centered, goal-oriented early physiotherapy approaches will be applied. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | Day 90 |
| Day 90 |
| Beaino G, Khoshnood B, Kaminski M, Marret S, Pierrat V, Vieux R, Thiriez G, Matis J, Picaud JC, Roze JC, Alberge C, Larroque B, Breart G, Ancel PY; EPIPAGE Study Group. Predictors of the risk of cognitive deficiency in very preterm infants: the EPIPAGE prospective cohort. Acta Paediatr. 2011 Mar;100(3):370-8. doi: 10.1111/j.1651-2227.2010.02064.x. Epub 2011 Jan 17. |
| 16357661 | Background | Cameron EC, Maehle V, Reid J. The effects of an early physical therapy intervention for very preterm, very low birth weight infants: a randomized controlled clinical trial. Pediatr Phys Ther. 2005 Summer;17(2):107-19. doi: 10.1097/01.pep.0000163073.50852.58. |
| 31690558 | Background | Draper ES, Zeitlin J, Manktelow BN, Piedvache A, Cuttini M, Edstedt Bonamy AK, Maier R, Koopman-Esseboom C, Gadzinowski J, Boerch K, van Reempts P, Varendi H, Johnson SJ; EPICE group. EPICE cohort: two-year neurodevelopmental outcomes after very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):350-356. doi: 10.1136/archdischild-2019-317418. Epub 2019 Nov 5. |
| 21382951 | Background | Guellec I, Lapillonne A, Renolleau S, Charlaluk ML, Roze JC, Marret S, Vieux R, Monique K, Ancel PY; EPIPAGE Study Group. Neurologic outcomes at school age in very preterm infants born with severe or mild growth restriction. Pediatrics. 2011 Apr;127(4):e883-91. doi: 10.1542/peds.2010-2442. Epub 2011 Mar 7. |
| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Telerehabilitation -Mothers | Mothers exercising in the telerehabilitation group |
| BG003 | Home-based - Mothers | Mothers exercising in the control group |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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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. |
| OG001 | Home-based | 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. |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 60 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 60 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 60 |
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| 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. | Risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
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| 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. | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
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| 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. | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
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| 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. | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 60 |
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| 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. | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
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| 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). | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
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| 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). | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
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| 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). | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 60 |
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| 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). | risky babies | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
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| 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. | Mothers of risky babies | Posted | Median | Inter-Quartile Range | score on a scale | Day 90 |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Home-based | The home-based group that will be given exercise training at the beginning of treatment and at 4., 8., and 12. Home-based: Family-centered, goal-oriented early physiotherapy approaches will be applied. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D006699 | Home Care Services |
| D003153 | Community Health Services |
| Male |
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