Locomotor Learning in Infants at High Risk for Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Gross Motor Function Measure-66
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 6 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •less than 6 weeks of age (corrected for prematurity, if applicable)
- •have a history of an early brain injury associated with high risk for cerebral palsy including periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures, or intracranial cystic lesion
- •family is able to commit to study visits
Exclusion Criteria
- •* known genetic condition unrelated to cerebral palsy (CP) or congenital abnormalities
- •Infants with fidgety movements on the General Movements Assessments (GMA) at 3 months of age or a score greater than -0.5sd below the mean on the Test of Infant Motor Performance at 4 months of age will not progress in the study because these infants are unlikely to have CP.
Arms & Interventions
Locomotor Learning
This study has three phases. The first phase of the study will be the observation of early spontaneous leg movements which will be measured monthly from 1-4 months of age.
The prone locomotor intervention phase using the Self-Initiated Prone Progression Crawler (SIPPC) will occur from 5-9 months of post-term age, or end earlier if the child achieves the ability to crawl six feet. Treatment will occur at an intensity of 3 times per week for 15-30 minutes. Infants will use the SIPPC for the duration of each therapy session
The upright locomotor intervention phase using DWS will occur from 9-18 months of age, or begin earlier if the child achieves the ability to crawl six feet before 9 months of age, and end earlier if the child achieves independent walking before 18 months of age. Treatment will occur at an intensity of 3 times per week for 30 minutes. Infants will receive dynamic weight support (DWS) for the duration of the 30-minute therapy session.
Intervention: Prone and Upright Locomotor Training (Behavioral)
Outcomes
Primary Outcomes
Gross Motor Function Measure-66
Time Frame: Up to 18 months
The Gross Motor Function Measure-66 (GMFM-66) is a Rasch-analyzed measure of gross motor function designed for children with cerebral palsy (CP). Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. Scores range from 0 to 100 with higher scores indicating more functional ability.
Movement Observation Coding System
Time Frame: Up to 18 months
The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.
Secondary Outcomes
- Error rate - prone(Up to 18 months)
- Error rate - upright(Up to 18 months)
- Movement index(Up to 18 months)
- Movement variability - prone(Up to 18 months)
- Postural control(Up to 18 months)
- Early spontaneous movement(Up to 4 months)
- Movement variability - upright(Up to 18 months)