Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04035291 |
| Other study ID # |
Sanko U |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
July 30, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Sanko University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
High risk infant is defined as infant with a negative history of environmental and biological
factors, which can lead to neuromotor development problems. It is a heterogeneous group of
premature infants born under thirty-seven weeks of age, with infants with low birth weight,
term or developmental retardation for various reasons. Therefore, preterm infants with low
birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy,
hearing and vision loss, mental retardation, speech and speech problems, and learning
difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is
based on the combination of some neurological and clinical signs. High-risk of infant
follow-up programs provide guidance for the treatment of neurodevelopmental delays and
deterioration in terms of early development. Three methods with the best predictable validity
that can determine CP before the adjusted age of 5-month is Magnetic Resonance Imaging (MRI),
Prechtl's Assessment of General Movements (GMs), Hammersmith Infant Neurological Evaluation.
In recent years, the diagnosis of high-risk of CP can be detected at 3 months with predictive
validity and reliability by evaluating the quality of GMs. GMs are now considered the gold
standard for early detection of CP because of its high sensitivity and specificity than MRI,
cranial US and neurological evaluations. It was also found that cognitive or language skills
may be inadequate in school age in patients with inadequate movement character and in the
same postural patterns according to age, although GMs are normal. So new clinical care
guidelines and new intervention research for infants with CP under the age of 2, needed to
have been shown. High-risk infants who are thought to have developmental disorders need early
intervention, but it is not yet known which interventions are more effective. In the
literature, although interventions are generally shown to have a greater impact on cognitive
development, their contribution to motor development cannot be fully demonstrated. The
effectiveness of physiotherapy programs in the diagnosis and treatment of CP has not been
clarified in the past years as a silent period. Therefore, studies involving early
physiotherapy programs are needed in infants at high risk for CP.
Description:
High-risk infants who are thought to have developmental disorders need early intervention,
but it is not yet unknown which interventions are more effective. In the literature, although
interventions are generally shown to have a greater impact on cognitive development, their
contribution to motor development cannot be fully demonstrated. Early physiotherapy and
rehabilitation in CP includes approaches starting from the neonatal period up to 24 months.
The main aim is to gain normal functional movements and to provide normal sensory input by
using the rapid learning ability resulting from brain plasticity. Thus, it is aimed to reach
the most independent level in terms of physical, cognitive, psychological and social aspects
within the physiological and anatomical deficiencies and environmental limitations of the
child. In the literature, there are studies including interventions to preterm infants with
high risk for developmental disorder. However, although the number of samples in the studies
is high, there is insufficient information about the rate of CP development. The
effectiveness of physiotherapy programs in the diagnosis and treatment of CP has not been
clarified in the past years as a silent period. Therefore, studies involving early
physiotherapy programs are needed in infants at high risk for CP. Preterm infants have been
shown to have difficulty in most functional areas due to lower academic success, welfare and
productivity. These difficulties may arise in childhood and adolescence due to brain damage
and structural changes. The stress of being away from mother contact has been proven in human
and experimental animal studies. Physical and emotional environment modifications of the
babies in the incubator environment can also reduce stress. Parent-centered trainings that
will increase sensitivity in the intensive care unit by reducing stresses in the brain in
terms of early intervention; it has been shown to have positive reflections on motor and
cognitive development in the short term. In the literature, it has been shown that the
specific motor education programs and the interventions that parents learn how to support the
development of their babies are the most important ways to increase the cognitive development
of infants at high risk by reducing motor disorders. It is essential to force babies to
produce motor behavior on their own, knowing the limits of motor behavior. It is then
essential to ensure that babies continue this activity and to use stimulations for this.
There may be positive developmental outcomes in physiotherapy models such as COPCA, where
parental coaching is performed. However, further studies are needed in this area. These
physiotherapy approaches are necessary to reduce the risk for motor and cognitive development
and to achieve normal motor development. In particular, the motor and cognitive development
of infants at high risk of CP should be monitored. In the literature, an early rehabilitation
model that includes physiotherapy in family routines has shown that some problems with high
risk of infants need to be focused on by early physiotherapy approach. In our study, the
effectiveness of family education and family cooperative physiotherapy programs in accordance
with NDT-based neurodevelopmental treatment principles applied to infants with high risk of
CP will be examined. The effect of physiotherapy methods applied to infants on motor and
cognitive development levels will be investigated according to the risk factors and
physiotherapy model. In addition, the effects of physiotherapy programs on the possibility of
decreasing the symptoms of CP or preventing the development of CP will be examined.
