Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System

Phase 2

Recruiting

• Conditions: Cerebral Palsy; Physical Therapy Modalities; Brain Injuries
• Interventions: Device: BabyG

• Registration Number: NCT06593886
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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.

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

Study Timeline

• Study Start: 2024-09-11
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Status Verified: 2025-05-23
• Last Update Submitted: 2025-05-24
• Last Update Posted: 2025-05-28
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	BabyG	This group will participate in active motor training at NIH while using the BabyG device immediately
Group B	BabyG	This group will participate in BabyG training after a 12 week baseline period

Primary Outcome Measures

Name	Time	Method
Change in the Bayley IV age equivalents and the GMFM-66	48 months	Compare change in the Bayley IV age equivalents and the GMFM-66 during the training and no-training periods.
Changes in EEG brain activity	48 months	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 Outcome Measures

Name	Time	Method
Changes in brain activation	48 months	Changes in brain activation will be correlated w/ changes in Bayley IV and GMFM-66
The absolute and percent change in muscle size of two muscle groups as a result of training	48 months	The absolute and percent change in muscle size of two muscle groups as a result of training
Infant age in months and the total training time in minutes	48 months	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

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States