Movement-based Infant Intervention

Not Applicable

Completed

• Conditions: Infant,Premature; Infant, Very Low Birth Weight; Infant Conditions; Infant, Small for Gestational Age; Infant Development
• Interventions: Behavioral: Movement Intervention

• Registration Number: NCT03082313
• Lead Sponsor: University of Southern California

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-11
• Study First Posted: 2017-03-17
• Study Start: 2017-09-01
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Results First Submitted: 2021-10-20
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Results First Posted: 2022-04-05
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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Exclusion Criteria

• Infants with congenital malformations of the legs will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Movement intervention	Movement Intervention	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.

Primary Outcome Measures

Name	Time	Method
Movement Rate	post intervention (intervention duration ranged from 2-6 months)	leg movements produced per hour of awake time, assessed using wearable sensors

Trial Locations

Locations (1)

Infant Neuromotor Control Laboratory; 🇺🇸 Los Angeles, California, United States