Cystic FibrosisNCT03381157
Fidgety Movements in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 3 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Observational General Movements Assessments
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2017to 2 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Being diagnosed with cystic fibrosis
- Being between the postterm 3rd and 5th months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Health Sciences, Departmant of Pyhsiotherapy and Rehabilitation
Ankara
About this study
Official title: Fidgety Movements Analysis in Infants With Cystic Fibrosis
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.
Read more
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Observational General Movements Assessments
- Keywords
- general movements, fidgety movements, motor optimality score
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational General Movements AssessmentsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis Group | Not described Receives: Other: Observational General Movements Assessments | |
| Control Group | Not described Receives: Other: Observational General Movements Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 minute for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start2 Oct 2017
- Primary completion2 Feb 2019
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akmer Mutlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381157
- Sponsor's protocol ID
- AkmerMutlu
- Status last verified
- Jul 2019
- First submitted
- 18 Dec 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28586709Einspieler 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.
PubMed 26997356
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fidgety Movements Analysis in Infants With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03381157
- Acronym / sponsor ID
- AkmerMutlu
- Conditions
- Cystic Fibrosis
- Keywords
- general movements, fidgety movements, motor optimality score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 2 Feb 2019 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis Group | – | Other: Observational General Movements Assessments |
| Control Group | – | Other: Observational General Movements Assessments |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Being diagnosed with cystic fibrosis
- Being between the postterm 3rd and 5th months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational General Movements AssessmentsGMs 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 | Other | Control Group, Cystic Fibrosis Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 28586709Herrero 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.
- Background: PubMed 26997356Einspieler 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.
- Prechtl´s Method on the Qualitative Assessment of General MovementsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Optimality Score (MOS) (time frame: 45 minute for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.