Movement-based Infant Intervention

NCT03082313 | Completed Results

• 1 other identifier: HS-16-00959
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

infant; leg movement; wearable sensors; early intervention

Outcome Measures

Primary Outcomes (1)

• Movement Rate

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

  post intervention (intervention duration ranged from 2-6 months)

Study Arms (1)

Movement intervention

EXPERIMENTAL

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.

Behavioral: Movement Intervention

Interventions

Movement Intervention BEHAVIORAL

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.

Movement intervention

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Infant Neuromotor Control Laboratory

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Beth Smith
• Organization: University of Southern California

beth.smith@usc.edu

13234424072

Study Officials

• Beth A Smith, PT, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Research

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 17, 2017
• Study Start: September 1, 2017
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)