Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593886
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
Status:
RECRUITING
Status Verified Date:
2024-09-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BabyG is a soft harness attached to a robotic system mounted overhead While wearing the harness the infant is free to move around a 10-by-10-foot play area with a padded floor The harness helps support the infant s weight it also slows any falls and catches the body before it hits the floor BabyG can be adjusted to support 5 to 50 of the infant s weight
Participants will be in the study for 24 weeks including 12 weeks with BabyG training and 12 weeks without Training will be 90 minutes per week either two 45-minute sessions or three 30-minute sessions
All participants will undergo tests during the 24 weeks such as
A test to measure an infant s ability to perform tasks such as rolling sitting crawling and walking
A test to assess nerve function movements reflexes posture and muscle tone
A test of brain activity while moving The infant will be fitted with a snug cap with 64 electrodes Then the infant will be placed in the BabyG harness and encouraged to take steps on a motorized treadmill Their movements will be filmed
Participants will be in the study for 24 weeks including 12 weeks with BabyG training and 12 weeks without Training will be 90 minutes per week either two 45-minute sessions or three 30-minute sessions
All participants will undergo tests during the 24 weeks such as
A test to measure an infant s ability to perform tasks such as rolling sitting crawling and walking
A test to assess nerve function movements reflexes posture and muscle tone
A test of brain activity while moving The infant will be fitted with a snug cap with 64 electrodes Then the infant will be placed in the BabyG harness and encouraged to take steps on a motorized treadmill Their movements will be filmed
Detailed Description:
Study Description
This phase IIb randomized crossover trial will evaluate the effects of 12 weeks of mobility training while in a computer-controlled robotic unweighting system BabyG on motor development rate in infants diagnosed with or at high risk for cerebral palsy CP who are less than 18 months old at enrollment compared to a 12-week period when they are not participating in training
Objectives
Primary 1 Evaluate the effects of mobility training with the BabyG robotic unweighting system on motor developmental rate in infants from 5 -18 months compared to an equivalent amount of time when they are not doing the training
Primary 2 Evaluate the effects of BabyG mobility training on EEG brain activation patterns during treadmill stepping with the least amount of support needed in infants 5 -18 months as compared to an equivalent amount of time when they are not doing the training
Secondary 1 Evaluate changes in muscle size of the rectus femoris and gastrocnemius muscles as assessed by muscle ultrasound before and after training and compared across training and no-training periods
Secondary 2 Relate the age at which the infant starts and their compliance with the BabyG training total training time with their
post-training outcomes
Endpoints
Primary Endpoint 1 Compare change in the Bayley IV age equivalents and the GMFM-66 during the training and no-training periods
Primary Endpoint 2 Changes in EEG brain activity during supported stepping on an infant treadmill as a result of training We will quantify and compare changes in the magnitude of activation in multiple EEG frequency bands in motor-related brain regions after
training and no-training periods
Secondary Endpoint 1 Changes in brain activation will be correlated w changes in Bayley IV and GMFM-66
Secondary Endpoint 2 The absolute and percent change in muscle size of two muscle groups as a result of training
Secondary Endpoint 3 The infant age in months and the total training time in minutes will be correlated with the pre-post change scores on motor EEG and muscle outcomes
This phase IIb randomized crossover trial will evaluate the effects of 12 weeks of mobility training while in a computer-controlled robotic unweighting system BabyG on motor development rate in infants diagnosed with or at high risk for cerebral palsy CP who are less than 18 months old at enrollment compared to a 12-week period when they are not participating in training
Objectives
Primary 1 Evaluate the effects of mobility training with the BabyG robotic unweighting system on motor developmental rate in infants from 5 -18 months compared to an equivalent amount of time when they are not doing the training
Primary 2 Evaluate the effects of BabyG mobility training on EEG brain activation patterns during treadmill stepping with the least amount of support needed in infants 5 -18 months as compared to an equivalent amount of time when they are not doing the training
Secondary 1 Evaluate changes in muscle size of the rectus femoris and gastrocnemius muscles as assessed by muscle ultrasound before and after training and compared across training and no-training periods
Secondary 2 Relate the age at which the infant starts and their compliance with the BabyG training total training time with their
post-training outcomes
Endpoints
Primary Endpoint 1 Compare change in the Bayley IV age equivalents and the GMFM-66 during the training and no-training periods
Primary Endpoint 2 Changes in EEG brain activity during supported stepping on an infant treadmill as a result of training We will quantify and compare changes in the magnitude of activation in multiple EEG frequency bands in motor-related brain regions after
training and no-training periods
Secondary Endpoint 1 Changes in brain activation will be correlated w changes in Bayley IV and GMFM-66
Secondary Endpoint 2 The absolute and percent change in muscle size of two muscle groups as a result of training
Secondary Endpoint 3 The infant age in months and the total training time in minutes will be correlated with the pre-post change scores on motor EEG and muscle outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None