- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313478
The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant
Study Overview
Status
Intervention / Treatment
Detailed Description
Preterm infants are observed to have reduced trunk extension in the prone position, rigid postural patterns while reaching a toy, fewer movement reactions, trunk rotation, head control, and muscle tone than term infants. To distinguish between the infant with typical motor development and the one with atypical / abnormal motor development and to follow up the level of their trunk controls is important to identify of the motor development delay in the early stage of life.
This cross-sectional study included 42 LBW infants and 43 NBW infants at between 3 and 9 months of age. We investigated the association between the gross motor function and the segmental trunk controls of the LBW infants at the 3-9 months of age compared to NBW infants.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- the written consent given by the parents,
- being at 3 to 9 months' corrected age,
- gestational age of less than 36 weeks + 6 days,
- birth weight of 2000 g or less.
Exclusion Criteria:
- Infants with any genetic, metabolic, orthopedic congenital abnormalities or chronic diseases and parents' rejection to participate in the study
- Term infants that presented any type of sensory or motor disorder were excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Low Birth Weight Infants
They were as follows: being at 3 to 9 months' corrected age, gestational age of less than 36 weeks + 6 days, birth weight of 2000 g or less.
Infants with any genetic, metabolic, orthopedic congenital abnormalities or chronic diseases and parents' rejection to participate in the study were excluded.
|
This cross-sectional study included LBW and NW infants at between 3 and 9 months of age.
The levels of trunk control were investigated by using the Segmental Assessment Trunk Control (SATCo).
The Alberta Infant Motor Scale (AIMS) were used for assessment of gross motor performance and identify typical and atypical motor development of infants.
|
Normal Weight Infants
They were as follows: being between 3 and 9 months of age, being full-term, had no complications during delivery.
Infants that presented any type of sensory or motor disorder were excluded.
|
This cross-sectional study included LBW and NW infants at between 3 and 9 months of age.
The levels of trunk control were investigated by using the Segmental Assessment Trunk Control (SATCo).
The Alberta Infant Motor Scale (AIMS) were used for assessment of gross motor performance and identify typical and atypical motor development of infants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alberta Infant Motor Scale (AIMS)
Time Frame: 15 min
|
The gross motor performance of infants were preliminarily evaluated with the Alberta Infant Motor Scale (AIMS).
The AIMS, an observational assessment scale, assesses the infants between 0 and 18 months and measures gross motor maturation in infants from birth through independent walking.
The AIMS has 58 items, which assess three aspects of motor performance--weight-bearing, posture and antigravity movements in the positions of supine, prone, sitting, and standing positions.
A typically developing 18-month-old infant can perform all movements and will obtain a total score of 58.
Gross motor performance is defined by the AIMS total score, which is expressed in percentiles based on age.
AIMS total score categories were determined by using normative percentile ranges.
The categories of gross motor performances were defined as follows: 0-10 atypical development, 11-25 suspected performance, 26-75 normal performance, 76-90 very good performance, 91-100 excellent performance.
|
15 min
|
Segmental Assessment Trunk Control (SATCo)
Time Frame: 20 min
|
The infants were evaluated by using the Segmental Assessment Trunk Control (SATCo).
SATCo is the only valid instrument that can assess the level of trunk control by segments and assess the ability of the typical or neuromotor deficient infant to maintain or recover a vertical position while sitting.
The infant was positioned in a sitting posture on a wooden bench with the pelvis maintained in a neutral position using a belt system in relation to the vertical axis and with the head upright to identify the level of trunk control.
0 and 1 scores were given according to maintenance of upright posture and the total score was calculated.
|
20 min
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Seval Kutlutürk, Istanbul Medipol University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28.03.2014-9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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