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Movement-based Infant Intervention

Primary Purpose

Infant Development, Infant,Premature, Infant, Very Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement Intervention
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant Development focused on measuring infant, leg movement, wearable sensors, early intervention

Eligibility Criteria

3 Months - 9 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Infant Neuromotor Control Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Movement intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2017
Last Updated
February 2, 2022
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03082313
Brief Title
Movement-based Infant Intervention
Official Title
Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Development, Infant,Premature, Infant, Very Low Birth Weight, Infant, Small for Gestational Age, Infant Conditions
Keywords
infant, leg movement, wearable sensors, early intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Movement intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Movement Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Movement Rate
Description
leg movements produced per hour of awake time, assessed using wearable sensors
Time Frame
post intervention (intervention duration ranged from 2-6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth A Smith, PT, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infant Neuromotor Control Laboratory
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Movement-based Infant Intervention

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