Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants

NCT04035291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-04-13

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Infant, Newborn, Disease
  • Infant, Small for Gestational Age
  • Infant Asphyxia
  • Infant, Very Low Birth Weight
  • Infant of Diabetic Mother
  • Infant, Premature, Diseases
  • Infant Development

Interventions

OTHER

exercise

exercises,play therapy models and positioning, handling and holding principles for babies, daily routins

Sponsors & Collaborators

  • Sanko University

    lead OTHER

Principal Investigators

  • Hatice Adıgüzel, PhD cd. · Sanko University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-07-30
Completion
2020-07-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035291 on ClinicalTrials.gov