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Trial record 12 of 12 for:    Recruiting, Not yet recruiting, Available Studies | "Infant, Small for Gestational Age"

Movement-based Infant Intervention

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ClinicalTrials.gov Identifier: NCT03082313
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Beth A. Smith, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Infant Development Infant,Premature Infant, Very Low Birth Weight Infant, Small for Gestational Age Infant Conditions Behavioral: Movement Intervention Not Applicable

Detailed Description:

Rationale: Dosing of pediatric physical therapy intervention is a current topic of high interest in the field, and researchers are starting to investigate the feasibility of different approaches for providing early, intense interventions. Although these approaches are laudable and strongly theoretically based there is a fundamental gap: it is currently unknown what amount and type of leg movement experience is necessary and sufficient to have a positive effect on the development of infant neuromotor control.

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 with 1/3 single and 2/3 bilateral leg movements.

Objective: The first aim is to determine the effectiveness of the intervention to increase leg movement and neurodevelopment in infants AR versus a cohort of infants from the same population who received standard care. The second aim is to determine the association of amount of leg movement experience and motor development rate.

Study population: This study will include 12 infants AR from 3 months of corrected age until sitting onset or 9 months corrected age, whichever occurs first.

Study methodology: Single-arm, prospective intervention study.

Study outcomes: The primary outcome will be leg movement rate at 9 months of corrected age and the secondary outcome will be neurodevelopmental outcomes (good or poor).

Follow-up: Families will be contacted every 4 months from 9-24 months of corrected age for updates on their child's medical and developmental status.

Statistics and plans for analysis. The investigators hypothesize that infants in this study (all of whom will receive the intervention) will have higher leg movement rates and lower risk of poor neuromotor outcomes at 9 months corrected age than an existing observation-only sample of infants from the same population who received usual care. The investigators will explore whether the relationship between amount of movement and rate of motor development is linear or non-linear.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: 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 with 1/3 single and 2/3 bilateral leg movements.
Behavioral: Movement Intervention
At each visit, the caregiver will be reminded of the infant's movement rate and proportion of unilateral and bilateral movements 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, with 1/3 single leg movements and 2/3 bilateral leg movements. 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 use 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 Measures :
  1. Movement rate [ Time Frame: average of monthly assessments from 3 to 9 months, assessed at 9 months of age ]
    leg movements produced per hour of awake time, assessed using wearable sensors


Secondary Outcome Measures :
  1. Motor development rate [ Time Frame: Change from 3 months in Alberta Infant Motor Scale at 9 months ]
    assessed using Alberta Infant Motor Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082313


Contacts
Contact: Beth A Smith, PT, PhD 3234424072 beth.smith@usc.edu

Locations
United States, California
Infant Neuromotor Control Laboratory Recruiting
Los Angeles, California, United States, 90089
Contact: Beth A Smith, PhD, PT    323-442-4072    beth.smith@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Beth A Smith, PT, PhD University of Southern California

Responsible Party: Beth A. Smith, Assistant Professor of Research, University of Southern California
ClinicalTrials.gov Identifier: NCT03082313     History of Changes
Other Study ID Numbers: HS-16-00959
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beth A. Smith, University of Southern California:
infant
leg movement
wearable sensors
early intervention

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms