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NCT Number: NCT05333224

Effectiveness of Telerehabilitation in High Risk of Infants

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.

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Key information

Conditions

Early Intervention

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telerehabilitation

Other

Family-centered, goal-oriented early physiotherapy approaches will be applied.

Home-based

Other

Family-centered, goal-oriented early physiotherapy approaches will be applied.

Primary outcomes

  1. Bayley III - Cognitive

    Time frame: 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.

  2. Bayley III - Cognitive Value at Day 30

    Time frame: 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.

  3. Bayley III - Cognitive Value at Day 60

    Time frame: 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.

  4. Bayley III - Cognitive Value at Day 90

    Time frame: 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.

  5. Bayley III - Language

    Time frame: 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.

  6. Bayley III - Language Value at Day 30

    Time frame: 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.

  7. Bayley III - Language Value at Day 60

    Time frame: 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.

  8. Bayley III - Language Value at Day 90

    Time frame: 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.

  9. Bayley III - Motor

    Time frame: 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.

  10. Bayley III - Motor Value at Day 30

    Time frame: 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.

  11. Bayley III - Motor Value at Day 60

    Time frame: 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.

  12. Bayley III - Motor Value at Day 90

    Time frame: 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.

  13. Hammersmith Infant Neurological Examination (HINE)

    Time frame: 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.

  14. HINE Value at Day 30

    Time frame: 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.

  15. HINE Value at Day 60

    Time frame: 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.

  16. HINE Value at Day 90

    Time frame: 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.

  17. Goal Attainment Scale (GAS)

    Time frame: 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).

  18. GAS Value at Day 30

    Time frame: 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).

  19. GAS Value at Day 60

    Time frame: 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).

  20. GAS Value at Day 90

    Time frame: 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).

Other outcomes

  1. Telerehabilitation Satisfication Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Effectiveness of Telerehabilitation-Based Family-Centered Goal-Directed Physiotherapy Approach in High Risk of Infants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2022
Registry last updated
Jun 13, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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