Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 5:49 PM
Study NCT ID:
NCT04561232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Locomotor Learning in Infants at High Risk for Cerebral Palsy
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Locomotor Learning in Infants at High Risk for Cerebral Palsy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).
Detailed Description:
Early spontaneous leg movements will be measured monthly from 1-4 months of age. Infants who remain at high risk for CP by month 4 as measured by the General Movements Assessment and the Test of Infant Motor Performance (TIMP) at 4 months of age will continue to locomotor training phases. Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC) will be delivered from 5-9 months of age. Upright locomotor training with dynamic weight support (DWS) will be delivered from 9-18 months of age. Repeated assessments of locomotor skill, movement quality, training characteristics, and variables that may mediate locomotor learning will be collected at time points from 1 month to 18 months of post-term age.
Investigators will examine the relationships between motor error and locomotor skill acquisition over time, anticipating that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP; the contribution of other training characteristics (movement time, movement variability, and postural control) to locomotor learning; and how learning is mediated by neurobehavioral factors outside of training. Investigators will develop comprehensive models of training predictors and mediators for prone and upright locomotor learning.
Investigators will examine the relationships between motor error and locomotor skill acquisition over time, anticipating that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP; the contribution of other training characteristics (movement time, movement variability, and postural control) to locomotor learning; and how learning is mediated by neurobehavioral factors outside of training. Investigators will develop comprehensive models of training predictors and mediators for prone and upright locomotor learning.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD098364-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |