Early InterventionNCT04313478
The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant
An observational study of Early Intervention and Low Birth Weight Infants, run by Istanbul Medipol University Hospital.
Trial summary
This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants. Read more about this study
- Who is it for?
- Ages 3 to 9 months
- Conditions the study is for
- Early Intervention, Low Birth Weight Infants, Term Infants
- What is being tested?
- Low Birth Weight and Normal Weight infants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 3 Mar 2020
- 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 9 months
- All sexes
- Child
Study population: Low birth weight and normal weight infants
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants.
Read the 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.
- Conditions
- Early Intervention, Low Birth Weight Infants, Term Infants
- Being tested
- Low Birth Weight and Normal Weight infants
- Keywords
- Early intervention, trunk control, low birth weight, term
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Birth Weight and Normal Weight infantsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Low Birth Weight and Normal Weight infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 May 2013
- Primary completion30 Jul 2014
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early InterventionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Sponsor
- Investigators
- Seval Kutlutürk, Principal investigator, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313478
- Sponsor's protocol ID
- 28.03.2014-9
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant
- ClinicalTrials.gov ID
- NCT04313478
- Acronym / sponsor ID
- 28.03.2014-9
- Conditions
- Early Intervention, Low Birth Weight Infants, Term Infants
- Keywords
- Early intervention, trunk control, low birth weight, term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 Jul 2014 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 18 Mar 2020 (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.
This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Birth Weight Infants | – | Behavioral: Low Birth Weight and Normal Weight infantsThey 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. |
| Normal Weight Infants | – | Behavioral: Low Birth Weight and Normal Weight infantsThey 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. |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Age groups
- Child
- Study population
- Low birth weight and normal weight infants
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Low Birth Weight and Normal Weight infantsThis 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. | Behavioural | Low Birth Weight Infants, Normal Weight Infants |
Primary outcome
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.
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.
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 4 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Seval Kutlutürk principal investigator
Istanbul Medipol University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Early Intervention and Low Birth Weight Infants, run by Istanbul Medipol University Hospital.
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 4 inclusion and 2 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Alberta Infant Motor Scale (AIMS) (time frame: 15 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2022.