- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06186323
Relationship Between Home Environment and Development in Children Diagnosed With Muscular Torticollis
Examining the Relationship Between Opportunities Offered in the Home Environment and Motor Development and Sensory Processing in Children Diagnosed With Congenital Muscular Torticollis
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Rabia ERASLAN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 1-15 months, with parental consent,
- Diagnosed with congenital muscular torticollis
- Their families will be included.
Exclusion Criteria:
- Children with chromosomal anomalies,
- serious congenital problems
- those whose parents do not volunteer to participate will not be included in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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congenital muscular torticollis
40 children diagnosed with congenital muscular torticollis, aged 0-15 months, with parental consent, without any vision or hearing problems, will be included in the study. Children with chromosomal anomalies, serious congenital problems and whose parents do not volunteer to participate will not be included in the study. During the evaluations, the demographic characteristics of the babies (gender, gestational age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score) will be recorded from the file and by interviewing the family. Photographs will be taken to ensure an objective evaluation. The Affordances in the Home Environment for Motor Development-Infant Scale will be used to explore and evaluate the home environment. It was planned to use the Test of Sensory Functions in Infants to evaluate the sensory development of babies. It is planned to use Peabody Motor Development Scale-2 to evaluate motor development. |
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.
Used to evaluate children's motor development with separate tests and rating scales for both gross motor skills and fine motor skills
his 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Affordances in the Home Environment for Motor Development-Infant Scale
Time Frame: 1-15 months
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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.
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1-15 months
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Peabody Developmental Motor Scales | Second Edition
Time Frame: 1-15 months
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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.
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1-15 months
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Test of Sensory Functıons ın Infants
Time Frame: 1-15 months
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It was planned to useTest of Sensory Functıons ın Infants (TSFI) to evaluate the sensory development of babies.
BDFT is frequently used to evaluate the sensory processing functions of babies aged 4-18 months.
It is used to determine whether a baby has a sensory processing problem and to what extent.
It consists of 24 items.
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1-15 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia ERASLAN, Study Principal Investigator-Gazi University
Publications and helpful links
General Publications
- Ohman A, Nilsson S, Lagerkvist AL, Beckung E. Are infants with torticollis at risk of a delay in early motor milestones compared with a control group of healthy infants? Dev Med Child Neurol. 2009 Jul;51(7):545-50. doi: 10.1111/j.1469-8749.2008.03195.x. Epub 2009 Jan 26.
- Sargent B, Kaplan SL, Coulter C, Baker C. Congenital Muscular Torticollis: Bridging the Gap Between Research and Clinical Practice. Pediatrics. 2019 Aug;144(2):e20190582. doi: 10.1542/peds.2019-0582.
- Cacola 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.
- Chiarello LA, Palisano RJ. Investigation of the effects of a model of physical therapy on mother-child interactions and the motor behaviors of children with motor delay. Phys Ther. 1998 Feb;78(2):180-94. doi: 10.1093/ptj/78.2.180.
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
- Torticollis and affordance
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
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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