Movement-based Infant Intervention

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082313
• Other study ID #: HS-16-00959
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 17, 2019

Study information

• Verified date: February 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 9 Months

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Infant Neuromotor Control Laboratory	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Rate	leg movements produced per hour of awake time, assessed using wearable sensors	post intervention (intervention duration ranged from 2-6 months)