Cerebral Palsy Clinical Trial
Official title:
Does Timing Matter? Efficacy of Parent Provided, Therapist Supported, Motor and Cognitive Intervention for Infants Born Very Preterm in the First Months of Life
Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. Impairment including reduced postural control, movement variability, visual motor skills, and motor learning are common during the first months of life and are associated with later developmental disabilities. However, infant born very preterm rarely receive evidence based therapeutic intervention in the first months of life when basic science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment in services delay the onset of services and delivery models rarely support targeted preventative intervention or enhanced parent engagement during in the transition from the neonatal intensive care unit (NICU) to home. Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes. Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation to empower parents in reading infant's behavioral cues, identifying ideal times for interaction, and enriching the environment and learning opportunities. Parents participate in 5 session in 3 weeks while learning principles of engagement, readiness for interaction, and to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical therapist support. The parent is empowered to determine the infant's current abilities and advance the activities to the "Just Right Challenge" throughout the 12 weeks, likely continuing after the intervention. The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the infants due date). Ninety infants will be randomly assigned to a Usual Care group, SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure at the end of each intervention period, 12 and 24 months of age.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05317234 -
Genetic Predisposition in Cerebral Palsy
|
N/A | |
Recruiting |
NCT05576948 -
Natural History of Cerebral Palsy Prospective Study
|
||
Completed |
NCT04119063 -
Evaluating Wearable Robotic Assistance on Gait
|
Early Phase 1 | |
Completed |
NCT03264339 -
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
|
N/A | |
Completed |
NCT05551364 -
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT03902886 -
Independent Walking Onset of Children With Cerebral Palsy
|
||
Recruiting |
NCT05571033 -
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
|
N/A | |
Not yet recruiting |
NCT04081675 -
Compliance in Children With Cerebral Palsy Supplied With AFOs
|
||
Completed |
NCT02167022 -
Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
|
N/A | |
Completed |
NCT04012125 -
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
|
N/A | |
Enrolling by invitation |
NCT05619211 -
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
|
Phase 1 | |
Completed |
NCT04489498 -
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
|
||
Completed |
NCT03677193 -
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
|
N/A | |
Recruiting |
NCT06450158 -
Robot-assisted Training in Children With CP
|
N/A | |
Completed |
NCT04093180 -
Intensive Neurorehabilitation for Cerebral Palsy
|
N/A | |
Completed |
NCT02909127 -
The Pediatric Eating Assessment Tool
|
||
Not yet recruiting |
NCT06377982 -
Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
|
Phase 1 | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT03183427 -
Corpus Callosum Size in Patients With Pineal Cyst
|
N/A | |
Active, not recruiting |
NCT03078621 -
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
|
Phase 1/Phase 2 |