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Fidgety Movements in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03381157
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Akmer Mutlu, Hacettepe University

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.


Condition or disease Intervention/treatment
Cystic Fibrosis Other: Observational General Movements Assessments

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fidgety Movements Analysis in Infants With Cystic Fibrosis
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : February 2, 2019
Actual Study Completion Date : February 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Cystic Fibrosis Group 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

Control Group 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




Primary Outcome Measures :
  1. Motor Optimality Score (MOS) [ Time Frame: 45 minute for each patient ]

    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.

    1. Fidgety Movements; normal fidgety: 12 points, abnormal fidgety: 4 points and sporadic fidgety: 1 points
    2. Age-adequacy of motor repertoire; normal motor repertoire: 4 points, decreased motor repertoire: 2 points, non age-adequacy of motor repertoire: 1 points
    3. 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
    4. Posture; normal posture: 4 points, equal normal and abnormal posture: 2 points, abnormal posture: 1 points
    5. Overall quality of the motor repertoire; normal: 4 points, abnormal: 2 points, cramped-synchronized: 1 points



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Ages Eligible for Study:   3 Months to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381157


Locations
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Turkey
Hacettepe University, Faculty of Health Sciences, Departmant of Pyhsiotherapy and Rehabilitation
Ankara, Turkey
Sponsors and Collaborators
Hacettepe University

Additional Information:
Publications:
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Responsible Party: Akmer Mutlu, Associate Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT03381157     History of Changes
Other Study ID Numbers: AkmerMutlu
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akmer Mutlu, Hacettepe University:
general movements, fidgety movements, motor optimality score
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases