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Locomotor Learning in Infants at High Risk for Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prone and Upright Locomotor Training
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, infant, physical therapy, motor learning, robotics

Eligibility Criteria

undefined - 6 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Locomotor Learning

Arm Description

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.

Outcomes

Primary Outcome Measures

Gross Motor Function Measure-66
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
The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.

Secondary Outcome Measures

Early spontaneous movement
Wearable sensor data will be analyzed to describe leg movements produced across in the natural environment.
Error rate - prone
Error during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Error rate - upright
Error during upright locomotor training will measured using the dynamic weight support (DWS) technology.
Movement index
Movement index is the percent of time moving during each therapy session which will be recorded by sensors.
Postural control
Postural control will be measured from video coding of therapy sessions.
Movement variability - prone
Movement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Movement variability - upright
Movement variability during upright locomotor training will be measured by video coding.

Full Information

First Posted
September 10, 2020
Last Updated
March 7, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Hospital Los Angeles, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04561232
Brief Title
Locomotor Learning in Infants at High Risk for Cerebral Palsy
Official Title
Locomotor Learning in Infants at High Risk for Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Hospital Los Angeles, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, infant, physical therapy, motor learning, robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Locomotor Learning
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Prone and Upright Locomotor Training
Other Intervention Name(s)
Crawling therapy, Walking therapy
Intervention Description
During the movement observation phase, infants will wear a wireless movement sensor at each ankle for two days. Research staff will show the caregivers how to place the sensors in the morning and charge them overnight. The training protocol for the prone training will consist of: 1) Warm-up. 2) Assisted movement of the arms and legs. 3) Calibration of the infant's arm and leg positions. 4) Self-initiated mobility for up to five minutes. For upright training, the environment will be arranged to encourage active motor exploration and variability in walking activities.The therapist will assist the child as needed to encourage upright locomotor activities, but only the minimum amount needed to perform the task. Weight assistance will be gradually reduced as postural control and coordination improve.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure-66
Description
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.
Time Frame
Up to 18 months
Title
Movement Observation Coding System
Description
The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Early spontaneous movement
Description
Wearable sensor data will be analyzed to describe leg movements produced across in the natural environment.
Time Frame
Up to 4 months
Title
Error rate - prone
Description
Error during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Time Frame
Up to 18 months
Title
Error rate - upright
Description
Error during upright locomotor training will measured using the dynamic weight support (DWS) technology.
Time Frame
Up to 18 months
Title
Movement index
Description
Movement index is the percent of time moving during each therapy session which will be recorded by sensors.
Time Frame
Up to 18 months
Title
Postural control
Description
Postural control will be measured from video coding of therapy sessions.
Time Frame
Up to 18 months
Title
Movement variability - prone
Description
Movement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Time Frame
Up to 18 months
Title
Movement variability - upright
Description
Movement variability during upright locomotor training will be measured by video coding.
Time Frame
Up to 18 months
Other Pre-specified Outcome Measures:
Title
Cognition
Description
The cognition age equivalent obtained from the Bayley Scales of Infant and Toddler Development- Fourth Edition (BSID-IV). This value describes what age the child is currently similar to in their cognitive performance, and all values are reported in months of age. The range of values on the scale 0-42 months of age. A higher number value means a greater cognitive ability.
Time Frame
Up to 18 months
Title
Motivation to Move Scale
Description
The Motivation to Move Scale is scored from video data of infant behavior during treatment sessions. Children are classified on a scale of 1 to 5 with higher scoring indicating increased motivation to move.
Time Frame
Up to 18 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Prosser, PhD
Phone
215-590-2495
Email
prosserl@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Prosser, PhD
Organizational Affiliation
Research Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Prosser, PhD
Phone
215-590-2495
Email
prosserl@chop.edu
First Name & Middle Initial & Last Name & Degree
Noor Ruwaih
Phone
267-426-7032
Email
ruwaihn@chop.edu

12. IPD Sharing Statement

Learn more about this trial

Locomotor Learning in Infants at High Risk for Cerebral Palsy

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