N/A N=26 Randomized Single-blind Supportive Care

Effectiveness of Telerehabilitation in High Risk of Infants

Early Intervention

Bottom Line

View on ClinicalTrials.gov: NCT05333224 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Bayley III - Cognitive — 77.69; 78.46 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Telerehabilitation (Other); Home-based (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Saglik Bilimleri Universitesi
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Bayley III - Cognitive	77.69; 78.46	—
PRIMARY Bayley III - Cognitive Value at Day 30	82.08; 77.08	—
PRIMARY Bayley III - Cognitive Value at Day 60	84.58; 73.33	—
PRIMARY Bayley III - Cognitive Value at Day 90	89.17; 82.08	—
PRIMARY Bayley III - Language	77.85; 83.38	—
PRIMARY Bayley III - Language Value at Day 30	85.17; 85.42	—
PRIMARY Bayley III - Language Value at Day 60	84.83; 82.75	—
PRIMARY Bayley III - Language Value at Day 90	89.92; 87.00	—
PRIMARY Bayley III - Motor	81.08; 88.54	—
PRIMARY Bayley III - Motor Value at Day 30	92.33; 88.08	—
PRIMARY Bayley III - Motor Value at Day 60	89.00; 81.50	—
PRIMARY Bayley III - Motor Value at Day 90	101.33; 95.08	—
PRIMARY Hammersmith Infant Neurological Examination (HINE)	51.92; 50.15	—
PRIMARY HINE Value at Day 30	58.08; 55.50	—
PRIMARY HINE Value at Day 60	66.50; 61.92	—
PRIMARY HINE Value at Day 90	74.00; 68.92	—
PRIMARY Goal Attainment Scale (GAS)	-1.62; -0.85	—
PRIMARY GAS Value at Day 30	-0.42; -1.25	—
PRIMARY GAS Value at Day 60	-0.33; -1.25	—
PRIMARY GAS Value at Day 90	0.50; -0.50	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05333224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.