Movement-based Infant Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/3/2019 |
| Start Date: | September 1, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Beth A Smith, PT, PhD |
| Email: | beth.smith@usc.edu |
| Phone: | 3234424072 |
Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay
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.
positive neurodevelopmental outcomes in infants at risk for developmental delay. The
intervention promotes movement experience from 3 months to sitting onset.
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.
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.
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.
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