- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188107
Interrater Reliability of Infant Motor Profile (IMP)
November 22, 2017 updated by: Ayse Numanoglu Akbas, Abant Izzet Baysal University
Interrater and Intrarater Reliability of Infant Motor Profile: Assessing Motor Profiles of Risky Infants
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
It is very hard to assess risky infants because of many problems like lack of cooperation, crying, discomfort ect.
But with "Infant Motor Profile (IMP)" it is possible to assess motor behavior of risky infants in their daily environment.
The assessment relays on video recordings so after recording the motor behavior many people can score the same children many times to have a certain idea about the infant.
With this tool it could be easier to set a therapy program after determining the basic motor problem.
In Turkey there are a lot of risky infants which later have diagnosed with Cerebral Palsy, Metabolic Disorders and other diseases.
Also there are a lot of infants with Down Syndrome (DS) and Spina Bifida (SB).
It has been known motor development is impaired with different childhood conditions but there is less information in literature about motor development of children with SB, DS and other diseases.
With this study motor status of risky infants between 3- 24 months old will be explored, interrater and intrarater reliability of Infant Motor Profile will be analyzed.
Study Type
Observational
Enrollment (Actual)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study population consists of risky infants (premature infants, low birth weighted infants, infants with spina bifida or down syndrome
Description
Inclusion Criteria:
- Clinical Diagnosis of Cerebral Palsy
- Clinical Diagnosis of Down Syndrome
- Clinical Diagnosis of Spina Bifida
Exclusion Criteria:
- Uncontrolled Epilepsy
- Severe Congenital Disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Risky Infants
Infants that have risk of developing motor impairment, or infants diagnosed as Spina Bifida, Down Syndrome ect.
|
All the infants included in this study will be assessed with Infant Motor Profile based on video recording.
|
Healthy Infants
Healthy infants that have normal motor development
|
All the infants included in this study will be assessed with Infant Motor Profile based on video recording.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant Motor Profile
Time Frame: Infants will be assessed at baseline and 3 months later from the first assessment.
|
Video recording based assessment of motor status
|
Infants will be assessed at baseline and 3 months later from the first assessment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayşe NUMANOĞLU AKBAŞ, PhD, Abant Izzet Baysal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
June 13, 2017
First Submitted That Met QC Criteria
June 14, 2017
First Posted (Actual)
June 15, 2017
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 22, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Body Weight
- Genetic Diseases, Inborn
- Intellectual Disability
- Nervous System Malformations
- Abnormalities, Multiple
- Chromosome Disorders
- Neural Tube Defects
- Cerebral Palsy
- Birth Weight
- Down Syndrome
- Metabolic Diseases
- Spinal Dysraphism
Other Study ID Numbers
- AbantIbu01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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