Fidgety Movements in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Fidgety Movements Analysis in Infants With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381157
• Other study ID #: AkmerMutlu
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: February 2, 2019

Study information

• Verified date: July 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2, 2019
• Est. primary completion date: February 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Observational General Movements Assessments
GMs assessment has been increasingly used to predict motor dysfunction, especially the Cerebral Palsy (SP), since its introduction 25 years ago. The GMs assessment is based on the visual holistic perception of normal and abnormal movements of the body. This approach focuses on spontaneous movements of the baby rather than reflexes, tonus, and reactions

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Health Sciences, Departmant of Pyhsiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Review. — View Citation

Herrero D, Einspieler C, Panvequio Aizawa CY, Mutlu A, Yang H, Nogolová 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Optimality Score (MOS)	The MOS has a max. value of 28 (for the best possible performance) and a min. value of 5. The score sheet comprises the following five sub-categories: fidgety movements, age-adequacy of motor repertoire, quality of movement patterns other than fidgety movements, posture, and overall quality of the motor repertoire.; Fidgety Movements; normal fidgety: 12 points, abnormal fidgety: 4 points and sporadic fidgety: 1 points; Age-adequacy of motor repertoire; normal motor repertoire: 4 points, decreased motor repertoire: 2 points, non age-adequacy of motor repertoire: 1 points; Quality of movement patterns other than fidgety movements; normal movement patterns: 4 points, equal normal and abnormal movement patterns: 2 points, abnormal movement patterns: 1 points; Posture; normal posture: 4 points, equal normal and abnormal posture: 2 points, abnormal posture: 1 points; Overall quality of the motor repertoire; normal: 4 points, abnormal: 2 points, cramped-synchronized: 1 points	45 minute for each patient

External Links

•   Prechtl´s Method on the Qualitative Assessment of General Movements