Movement-based Infant Intervention

Study Overview
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Brief Summary
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The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. The intervention promotes movement experience from 3 months to sitting onset.

Detailed Description
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Aim: Our purpose was to assess daily leg movement rate before and after a caregiver-provided in-home intervention for infants at risk for developmental disability. We also assessed adherence and quality of caregiver-child interaction. Methods: Twelve infants, at risk for developmental disabilities, and their caregivers participated in an intervention focused on increasing leg movements. Intervention started between 3- and 6-months cor- rected age and ended once the infant was able to sit independently or at 9 months corrected age, whichever occurred first. Infants were assessed monthly.

Official Title
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Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay

Conditions
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Infant Development, Infant,Premature, Infant, Very Low Birth Weight, Infant, Small for Gestational Age, Infant Conditions

Intervention / Treatment
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* Behavioral: Movement Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants will be 3 months of adjusted age at the first visit, +/- 10 days. Infants will be defined as at risk if they qualify for high risk infant follow up care as defined by California Children's Services. Exclusion Criteria: Infants with congenital malformations of the legs will be excluded.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Movement intervention<br>The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time. | Behavioral: Movement Intervention<br>* At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Rate | leg movements produced per hour of awake time, assessed using wearable sensors | post intervention (intervention duration ranged from 2-6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, leg movement, wearable sensors, early intervention