Movement-based Infant Intervention

NCT ID: NCT03082313

Last Updated: 2022-04-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-12-17

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Movement intervention

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.

Group Type EXPERIMENTAL

Movement Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Beth A. Smith

Assistant Professor of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth A Smith, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Infant Neuromotor Control Laboratory

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HS-16-00959

Identifier Type: -

Identifier Source: org_study_id

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