Clinical trial NCT05333224: Effectiveness of Telerehabilitation in High Risk of Infants
Official title: Effectiveness of Telerehabilitation-Based Family-Centered Goal-Directed Physiotherapy Approach in High Risk of Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Intervention
Keywords: Risky Baby
Telerehabilitation
Family-centered approach
Early Intervention
Goal-directed physiotherapy
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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

Primary outcomes:
measure: Bayley III - Cognitive
timeFrame: Day 0
measure: Bayley III - Cognitive Value at Day 30
timeFrame: Day 30
measure: Bayley III - Cognitive Value at Day 60
timeFrame: Day 60
measure: Bayley III - Cognitive Value at Day 90
timeFrame: Day 90
measure: Bayley III - Language
timeFrame: Day 0
measure: Bayley III - Language Value at Day 30
timeFrame: Day 30
measure: Bayley III - Language Value at Day 60
timeFrame: Day 60
measure: Bayley III - Language Value at Day 90
timeFrame: Day 90
measure: Bayley III - Motor
timeFrame: Day 0
measure: Bayley III - Motor Value at Day 30
timeFrame: Day 30
measure: Bayley III - Motor Value at Day 60
timeFrame: Day 60
measure: Bayley III - Motor Value at Day 90
timeFrame: Day 90
measure: Hammersmith Infant Neurological Examination (HINE)
timeFrame: Day 0
measure: HINE Value at Day 30
timeFrame: Day 30
measure: HINE Value at Day 60
timeFrame: Day 60
measure: HINE Value at Day 90
timeFrame: Day 90
measure: Goal Attainment Scale (GAS)
timeFrame: Day 0
measure: GAS Value at Day 30
timeFrame: Day 30
measure: GAS Value at Day 60
timeFrame: Day 60
measure: GAS Value at Day 90
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
measure: Telerehabilitation Satisfication Survey
timeFrame: Day 90
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University
name: Ayca Evkaya Acar, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri University
name: Esra Pehlivan, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Marmara University
name: Evrim Karadag Saygi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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