Clinical trial NCT03381157: Fidgety Movements in Cystic Fibrosis
Official title: Fidgety Movements Analysis in Infants With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: general movements, fidgety movements, motor optimality score
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 38
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postterm 3-5 months of cystic fibrosis diagnosed and postterm 3-5 months healthy infants will be included to the study. The number of individuals to be included in the cystic fibrosis group was determined as 19 according to the power analysis at α = 0.05 and β = 0.20 (for 80% power). Within the scope of our study, the control group, which will be formed from postpartum 3-5 month healthy infants, will be composed of our patients who have been taken to the rehabilitation sessions of our clinic on the given days as well as our patients who have been in control for a certain period of time at Hacettepe University Department of Physiotherapy and Rehabilitation, Developmental and Early Physiotherapy Unit, relatives.

Brief summary: Very low birth weight infants who are at risk for chronic lung diseases may also be at risk for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage. Infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental outcomes than healthy infants. It has also been pointed out that babies with prolonged and recurrent apneas during sleep may have weak General Movements (GMs) repertoire.

It has been mentioned that motor development retardation may also occur in neurodevelopmental diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. In infants with cystic fibrosis, motor development may be affected by increased incidence of hospitalization, previous infections, malnutrition, respiratory and digestive system disorders. There is no research done with GMs assessment to determine motor dysfunction in infants with cystic fibrosis and this topic is open to research.

Having more information about the motor development of babies by determining the motor characteristics and motor performance of infants with cystic fibrosis, it may be possible to start the disease-specific physiotherapy and rehabilitation programs as early as possible. For this reasons, in the study the investigators aimed to investigate the characteristics of GMs in the "Fidgety" period of 3-5 month term infants diagnosed with cystic fibrosis, to determine the motor performances and to investigate the relation between the GMs characteristics and the features of the disease.

The hypotheses the investigators have set for this study are listed below;

Ho: Spontaneous movements of the "Fidgety" period of infants diagnosed with 3-5 months of cystic fibrosis are not different from normal infants.

H1: Spontaneous movements of "Fidgety" period of infants diagnosed with cystic fibrosis between 3-5 months are different from normal infants.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with cystic fibrosis
* Being between the postterm 3rd and 5th months

Exclusion Criteria:

* Having congenital anomalies,
* Having an ongoing infection,
* Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
* Fidgety movements evaluation results; being abnormal (AF), sporadic (F +/-) or non-F (F-)
* Baby's family does not want to be involved in the work

Primary outcomes:
measure: Motor Optimality Score (MOS)
timeFrame: 45 minute for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences, Departmant of Pyhsiotherapy and Rehabilitation
Study officials:
References:
citation: Herrero D, Einspieler C, Panvequio Aizawa CY, Mutlu A, Yang H, Nogolova A, Pansy J, Nielsen-Saines K, Marschik PB; GenGM Study Group. The motor repertoire in 3- to 5-month old infants with Down syndrome. Res Dev Disabil. 2017 Aug;67:1-8. doi: 10.1016/j.ridd.2017.05.006. Epub 2017 Jun 3.
citation: Einspieler C, Peharz R, Marschik PB. Fidgety movements - tiny in appearance, but huge in impact. J Pediatr (Rio J). 2016 May-Jun;92(3 Suppl 1):S64-70. doi: 10.1016/j.jped.2015.12.003. Epub 2016 Mar 17.