NCT04313478

Brief Summary

This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2014

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

February 4, 2022

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

March 13, 2020

Last Update Submit

January 21, 2022

Conditions

Keywords

Early intervention, trunk control, low birth weight, term

Outcome Measures

Primary Outcomes (2)

  • Alberta Infant Motor Scale (AIMS)

    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)

    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

Study Arms (2)

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.

Behavioral: Low Birth Weight and Normal Weight 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.

Behavioral: Low Birth Weight and Normal Weight infants

Interventions

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.

Low Birth Weight InfantsNormal Weight Infants

Eligibility Criteria

Age3 Months - 9 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Low birth weight and normal weight infants

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Seval Kutlutürk

    Istanbul Medipol University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 18, 2020

Study Start

May 1, 2013

Primary Completion

July 30, 2014

Study Completion

March 3, 2020

Last Updated

February 4, 2022

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share