Effectiveness of Telerehabilitation in High Risk of Infants

NCT05333224 | Completed Results

• 1 other identifier: 09.2021.853
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

While the mortality rate in preterm births has decreased thanks to recent developments in the field of medicine, disability risk factors increase for premature babies. Premature birth, low birth weight, and all accompanying problems in this process reveal the concept of the risky baby. Early intervention is very important for these babies who are at risk for neurodevelopmental problems. Although early intervention is a general concept, the subject the investigators focus on is early physiotherapy approaches. Early physiotherapy approaches include many methods. However, recently, family-centered approaches have been emphasized and studies have been carried out on this issue; Likewise, the goal-oriented therapy approach, which is a treatment with a high level of evidence, is also being investigated. Telerehabilitation, on the other hand, has become a method that is frequently used with the increase in the use of technological methods. The effectiveness of family-centered, goal-oriented physiotherapy approaches is known in previous studies on this subject; There are studies conducted on a remotely monitored portable intelligent system created for telerehabilitation, but no studies have been found in which telerehabilitation has been applied using the real-time video conferencing method.

Conditions

Early Intervention

Keywords

Risky Baby; Telerehabilitation; Family-centered approach; Early Intervention; Goal-directed physiotherapy

Outcome Measures

Primary Outcomes (20)

• 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.

  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

Other Outcomes (1)

• Telerehabilitation Satisfication Survey

  Day 90

Study Arms (2)

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.

Other: Telerehabilitation

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.

Other: Home-based

Interventions

Telerehabilitation OTHER

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

Telerehabilitation

Home-based OTHER

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

Home-based

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27571484 BACKGROUND

• 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.

  PMID: 21241364 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.

  PMID: 16357661 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.

  PMID: 31690558 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.

  PMID: 21382951 BACKGROUND

MeSH Terms

Interventions

Telerehabilitation; Home Care Services, Hospital-Based

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Home Care Services; Community Health Services

Results Point of Contact

• Title: Ayca Evkaya Acar
• Organization: Istanbul Medeniyet University

ayca.evkaya@gmail.com

+905544263263

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: April 18, 2022
• Study Start: June 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: September 20, 2023
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)