Movement-based Infant Intervention

Not Applicable

Completed

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

• 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.

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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