Trials / Completed
CompletedNCT03082313
Movement-based Infant Intervention
Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 3 Months – 9 Months
- Healthy volunteers
- Not accepted
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.
Conditions
- Infant Development
- Infant,Premature
- Infant, Very Low Birth Weight
- Infant, Small for Gestational Age
- Infant Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2017-09-01
- Primary completion
- 2019-12-17
- Completion
- 2019-12-17
- First posted
- 2017-03-17
- Last updated
- 2022-04-05
- Results posted
- 2022-04-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03082313. Inclusion in this directory is not an endorsement.