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Clinical Trials/NCT03082313
NCT03082313
Completed
N/A

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

University of Southern California1 site in 1 country12 target enrollmentSeptember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant Development
Sponsor
University of Southern California
Enrollment
12
Locations
1
Primary Endpoint
Movement Rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
December 17, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beth A. Smith

Assistant Professor of Research

University of Southern California

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Movement Rate

Time Frame: post intervention (intervention duration ranged from 2-6 months)

leg movements produced per hour of awake time, assessed using wearable sensors

Study Sites (1)

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