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Movement-based Infant Intervention

NCT03082313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-04-05

Study results available
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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.

Conditions

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

Interventions

BEHAVIORAL

Movement Intervention

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.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Beth A Smith, PT, PhD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-12-17
Completion
2019-12-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082313 on ClinicalTrials.gov