Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Salamanca
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- EEG (Alpha, Beta, Theta)
Study Overview
Brief Summary
Experimental cross-sectional study of a single application (vojta therapy or massage) in preterm and non-preterm infants to test whether there are differences in brain activation and oxygenation that occur with both techniques between term and preterm infants.
Secondly, the brain activation and oxygenation produced by both physiotherapy techniques will be tested separately to establish comparisons between the two groups.
Finally, between 3 - 6 months, we will analyse whether there are changes in gaze fixation (eye tracker) in the 4 study arms to see if there are differences between term and preterm infants but also the differences between the immediate effectiveness of both techniques.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Investigator)
Masking Description
Invesigator will not know which infants are premature or not
Eligibility Criteria
- Ages
- 7 Days to 1 Month (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •term and preterm babys
- •first month after birth
Exclusion Criteria
- •intrumental delivery
- •pathology associated
Arms & Interventions
Preterm group 1
To analize the brain activation and oxigenation using the Vojta Therapy
Intervention: Vojta Therapy (Other)
Preterm Group 2
To analize the brain activation and oxigenation using massotherapy
Intervention: Massotherapy (Other)
Term group 1
To analize the brain activation and oxigenation using the Vojta Therapy
Intervention: Vojta Therapy (Other)
Term group 2
To analize the brain activation and oxigenation using massotherapy
Intervention: Massotherapy (Other)
Outcomes
Primary Outcomes
EEG (Alpha, Beta, Theta)
Time Frame: Change from Baseline brain activation at 3 months
Brain activation
NIRS
Time Frame: Change from Baseline brain oxigenation at 3 months
Brain oxigenation
Secondary Outcomes
- Eye tracker(Change from Baseline gaze fization at 6 months)
Investigators
Rocío Llamas-Ramos
Associate Professor
University of Salamanca