Examination of the Relationship Between Home Affordances With Development
1 other identifier
observational
50
1 country
1
Brief Summary
Babies with a history of premature birth and low birth weight are at risk for developmental disorders. These infants may have motor, cognitive and behavioral problems compared to their term peers. Although advances in technology lead to an increase in survival rate, 50% of these infants may have developmental delays in motor, cognitive and behavioral areas. Premature birth does not accelerate any of the early sensory development processes, but exposure to intense, unusual stimuli of unusual character may delay or inhibit sensory development. Therefore, children born prematurely may be at risk in terms of sensory processing. The physical, sensory and social environment of the infant and young child is critical in supporting the healthy and appropriate development of the brain and nerve-sensory systems.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Sep 2022
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedDecember 5, 2023
December 1, 2023
1 year
January 14, 2022
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Affordances in the Home Environment for Motor Development-Infant Scale
Affordances in the Home Environment for Motor Development-Infant Scale is a parent-filled assessment to determine the nature and amount of factors affecting infant motor skill development in the home environment, including the availability of toys, materials, and the availability of spaces. The scale consists of 41 items in total. For babies aged 3-12 months, questions up to the first 32 items are answered. It is stated that other substances are not suitable for babies under 12 months. All substances are applied to babies between 12-18 months. Questions answered as yes or no are scored as 0.1 (0: no, 1: yes). Other questions are scored as 0, 1, 2, 3. For babies up to 12 months, a total of 66 points is obtained. For babies older than 12 months, a total of 93 points is obtained. A higher score indicates better environmental enrichment.
4-18 months
Test of Sensory Functıons ın Infants
This test helps you identify infants with sensory integrative dysfunction-including those at risk for developing learning disabilities as they grow older. All subtests consist of a total of 24 items. In the tactile deep pressure response section, it is scored as 0: reverse response, 1: mild defensive response, and 2: integrated response. In the adaptive motor response section, it is scored as 0: no response, 1: disorganized, 2: partial, 3: organized. In the visual-tactile integration section, it is scored as 0: hyperactive, 1: hyporeactive, and 2: normal. The oculomotor test section is scored as 0: no response or poorly integrated, 1: well integrated. Response to vestibular stimulation is scored as 0: adverse response, 1: mild defensive response, and 2: integrated response. The total score ranges from 0 to 49. In 10-12-month-old babies, 44-49 points indicate good sensory function, 41-43 points indicate risky status, 0-40 points sensory processing problem.
4-18 months
Peabody Developmental Motor Scales | Second Edition
Peabody Developmental Motor Scales \| Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years. It consists of gross motor and fine motor parts. The Gross motor section includes 151 items from 4 subtests: reflexes, stasis, locomotion, and object manipulation. The fine motor section consists of 2 subtests and 98 items: comprehension and visual-motor integration. The total motor part is the sum of the items in the gross and fine 25 motor parts. Items are scored with 0, 1, and 2 points. When the child performs the item according to the specified item criteria, 2 points are given. 1 point is awarded when the behavior occurs but the criteria for successful performance are not fully met. A score of 0 is given when the child is unable to try the item or does not reveal any skills when he tries it. Results are expressed as a raw score, standard score, or total motor score.
4-18 months
Study Arms (1)
premature babies
Fifty infants between 4-18 months with a history of premature birth and with the consent of their parents will be included in the study. Babies with the chromosomal anomalies, serious congenital problems, and whose parents are not willing to work will not be included in the study.
Interventions
Affordances in the Home Environment for Motor Development-Infant Scale is a parent-filled assessment to determine the nature and amount of factors affecting infant motor skill development in the home environment, including the availability of toys, materials, and the availability of spaces.
Peabody Developmental Motor Scales \| Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years.
This test helps you identify infants with sensory integrative dysfunction-including those at risk for developing learning disabilities as they grow older. The TSFI provides objective criteria that allow you to determine whether, and to what extent, an infant has deficits in sensory functioning. Designed for use with children from 4 months to 18 months old, the TSFI provides an overall measure of sensory processing and reactivity, as well as scores on the following subdomains: Reactivity to Tactile Deep Pressure Visual Tactile Integration Adaptive Motor Function Ocular Motor Control Reactivity to Vestibular Stimulation
Eligibility Criteria
It was planned to include infants who applied to Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department Pediatric Rehabilitation unit in the study. Fifty infants between 4-18 months with a history of premature birth and with the consent of their parents will be included in the study. Babies with chromosomal anomalies, serious congenital problems, and whose parents are not willing to work will not be included in the study. In the evaluations, the demographic characteristics of the babies (sex, gestational age, corrected age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score, treatments received, history of staying in the intensive care unit, risk factors) will be recorded in the file and by interviewing the family.
You may not qualify if:
- Babies with chromosomal anomaly, serious congenital problems and whose parents are not willing to work will not be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Rabia Eraslan
Yenimahalle, Ankara, Turkey (Türkiye)
Related Publications (5)
Woodward LJ, Anderson PJ, Austin NC, Howard K, Inder TE. Neonatal MRI to predict neurodevelopmental outcomes in preterm infants. N Engl J Med. 2006 Aug 17;355(7):685-94. doi: 10.1056/NEJMoa053792.
PMID: 16914704BACKGROUNDNoble Y, Boyd R. Neonatal assessments for the preterm infant up to 4 months corrected age: a systematic review. Dev Med Child Neurol. 2012 Feb;54(2):129-39. doi: 10.1111/j.1469-8749.2010.03903.x. Epub 2011 Dec 5.
PMID: 22142216BACKGROUNDKaya-Kara O, Kerem-Gunel M, Yigit S. Correlation of the Bayley scales of infant-toddler development-3rd edition and neuro-sensory motor assessment in preterm infants during the first year of life. Turk J Pediatr. 2019;61(3):399-406. doi: 10.24953/turkjped.2019.03.012.
PMID: 31916718BACKGROUNDCacola PM, Gabbard C, Montebelo MI, Santos DC. Further Development and Validation of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). Phys Ther. 2015 Jun;95(6):901-23. doi: 10.2522/ptj.20140011. Epub 2014 Dec 18.
PMID: 25524875BACKGROUNDCacola P, Gabbard C, Santos DC, Batistela AC. Development of the Affordances in the Home Environment for Motor Development-Infant Scale. Pediatr Int. 2011 Dec;53(6):820-5. doi: 10.1111/j.1442-200X.2011.03386.x.
PMID: 21507146BACKGROUND
Biospecimen
motor and sensory development assesment
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rabia Eraslan
Gazi University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
December 5, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share