Trial Outcomes & Findings for Effectiveness of Telerehabilitation in High Risk of Infants (NCT NCT05333224)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Day 0

Results posted on

2025-06-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study - Infants STARTED	13	13
Overall Study - Infants COMPLETED	12	12
Overall Study - Infants NOT COMPLETED	1	1
Overall Study - Mothers STARTED	13	13
Overall Study - Mothers COMPLETED	12	12
Overall Study - Mothers NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study - Infants Lost to Follow-up	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telerehabilitation - Infants n=13 Participants 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.	Home-based - Infants n=13 Participants 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.	Telerehabilitation -Mothers n=13 Participants Mothers exercising in the telerehabilitation group	Home-based - Mothers n=13 Participants Mothers exercising in the control group	Total n=52 Participants Total of all reporting groups
Age, Continuous	0.54 years STANDARD_DEVIATION 0.06 • n=13 Participants	0.58 years STANDARD_DEVIATION 0.07 • n=13 Participants	28.85 years STANDARD_DEVIATION 4.67 • n=13 Participants	32.77 years STANDARD_DEVIATION 5.29 • n=13 Participants	15.68 years STANDARD_DEVIATION 2.52 • n=52 Participants
Sex: Female, Male Female	6 Participants n=13 Participants	7 Participants n=13 Participants	13 Participants n=13 Participants	13 Participants n=13 Participants	39 Participants n=52 Participants
Sex: Female, Male Male	7 Participants n=13 Participants	6 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=13 Participants	13 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Day 0

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=13 Participants 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.	Home-based n=13 Participants 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.
Bayley III - Cognitive	77.69 score on a scale Standard Deviation 15.22	78.46 score on a scale Standard Deviation 14.19

PRIMARY outcome

Timeframe: Day 30

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Cognitive Value at Day 30	82.08 score on a scale Standard Deviation 11.76	77.08 score on a scale Standard Deviation 10.10

PRIMARY outcome

Timeframe: Day 60

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Cognitive Value at Day 60	84.58 score on a scale Standard Deviation 10.32	73.33 score on a scale Standard Deviation 12.67

PRIMARY outcome

Timeframe: Day 90

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Cognitive Value at Day 90	89.17 score on a scale Standard Deviation 7.63	82.08 score on a scale Standard Deviation 8.64

PRIMARY outcome

Timeframe: Day 0

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=13 Participants 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.	Home-based n=13 Participants 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.
Bayley III - Language	77.85 score on a scale Standard Deviation 10.76	83.38 score on a scale Standard Deviation 7.27

PRIMARY outcome

Timeframe: Day 30

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Language Value at Day 30	85.17 score on a scale Standard Deviation 7.86	85.42 score on a scale Standard Deviation 4.92

PRIMARY outcome

Timeframe: Day 60

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Language Value at Day 60	84.83 score on a scale Standard Deviation 5.25	82.75 score on a scale Standard Deviation 4.39

PRIMARY outcome

Timeframe: Day 90

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Language Value at Day 90	89.92 score on a scale Standard Deviation 2.81	87.00 score on a scale Standard Deviation 5.76

PRIMARY outcome

Timeframe: Day 0

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=13 Participants 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.	Home-based n=13 Participants 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.
Bayley III - Motor	81.08 score on a scale Standard Deviation 13.49	88.54 score on a scale Standard Deviation 11.14

PRIMARY outcome

Timeframe: Day 30

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Motor Value at Day 30	92.33 score on a scale Standard Deviation 12.07	88.08 score on a scale Standard Deviation 9.99

PRIMARY outcome

Timeframe: Day 60

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Motor Value at Day 60	89.00 score on a scale Standard Deviation 9.42	81.50 score on a scale Standard Deviation 8.93

PRIMARY outcome

Timeframe: Day 90

Population: Risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Bayley III - Motor Value at Day 90	101.33 score on a scale Standard Deviation 5.86	95.08 score on a scale Standard Deviation 6.72

PRIMARY outcome

Timeframe: Day 0

Population: risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=13 Participants 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.	Home-based n=13 Participants 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.
Hammersmith Infant Neurological Examination (HINE)	51.92 score on a scale Standard Deviation 7.22	50.15 score on a scale Standard Deviation 7.09

PRIMARY outcome

Timeframe: Day 30

Population: risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
HINE Value at Day 30	58.08 score on a scale Standard Deviation 7.09	55.50 score on a scale Standard Deviation 6.08

PRIMARY outcome

Timeframe: Day 60

Population: risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
HINE Value at Day 60	66.50 score on a scale Standard Deviation 4.60	61.92 score on a scale Standard Deviation 6.14

PRIMARY outcome

Timeframe: Day 90

Population: risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
HINE Value at Day 90	74.00 score on a scale Standard Deviation 3.24	68.92 score on a scale Standard Deviation 6.59

PRIMARY outcome

Timeframe: Day 0

Population: risky babies

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).

Outcome measures

Outcome measures
Measure	Telerehabilitation n=13 Participants 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.	Home-based n=13 Participants 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.
Goal Attainment Scale (GAS)	-1.62 score on a scale Standard Deviation 0.76	-0.85 score on a scale Standard Deviation 1.06

PRIMARY outcome

Timeframe: Day 30

Population: risky babies

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).

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
GAS Value at Day 30	-0.42 score on a scale Standard Deviation 1.37	-1.25 score on a scale Standard Deviation 0.96

PRIMARY outcome

Timeframe: Day 60

Population: risky babies

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).

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
GAS Value at Day 60	-0.33 score on a scale Standard Deviation 0.88	-1.25 score on a scale Standard Deviation 0.75

PRIMARY outcome

Timeframe: Day 90

Population: risky babies

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).

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
GAS Value at Day 90	0.50 score on a scale Standard Deviation 0.90	-0.50 score on a scale Standard Deviation 0.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: Mothers of risky babies

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.

Outcome measures

Outcome measures
Measure	Telerehabilitation n=12 Participants 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.	Home-based n=12 Participants 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.
Telerehabilitation Satisfication Survey	40 score on a scale Interval 38.25 to 40.0	35.5 score on a scale Interval 35.0 to 36.0

Adverse Events

Telerehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home-based

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ayca Evkaya Acar

Istanbul Medeniyet University

Phone: +905544263263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place