← Back to Search

BabyG Harness for Cerebral Palsy

Phase 2
Recruiting
Led By Diane L Damiano, Ph.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 5 months and no more than 18 months of age at enrollment (adjusted for prematurity for those 37 weeks of gestation or less and based on their due date)
Diagnosis of CP or high risk of CP
Must not have
Seizure disorder that is not controlled by medication
History of surgery to the upper or lower extremities in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial involves testing a harness called BabyG that supports infants as they move around a play area. The study will last for 24 weeks, with participants using BabyG for 12 weeks and not

Who is the study for?
This trial is for infants with conditions like cerebral palsy or traumatic brain injury that affect movement. It's designed to help them move more easily and safely in a controlled play area using the BabyG robotic unweighting system.
What is being tested?
The study tests the BabyG system, which supports part of an infant's weight while they move around. Infants will use this system for 12 weeks and then go without it for another 12 weeks, with their mobility skills and nerve functions being assessed throughout.
What are the potential side effects?
Since this intervention involves physical support during movement, potential side effects may include skin irritation from the harness or discomfort due to unfamiliarity with the equipment. However, risks are likely minimal as safety measures are in place.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 5 to 18 months old, adjusted for early birth if applicable.
Select...
I have been diagnosed with cerebral palsy or am at high risk for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My seizures are not controlled by medication.
Select...
I have had surgery on my arms or legs in the last 6 months.
Select...
I am currently taking baclofen for muscle stiffness.
Select...
I can walk 10 steps on my own, with or without support like a cane.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Bayley IV age equivalents and the GMFM-66
Changes in EEG brain activity
Secondary study objectives
Changes in brain activation
Infant age in months and the total training time in minutes
The absolute and percent change in muscle size of two muscle groups as a result of training

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
This group will participate in BabyG training after a 12 week baseline period
Group II: Group AExperimental Treatment1 Intervention
This group will participate in active motor training at NIH while using the BabyG device immediately

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,879,782 Total Patients Enrolled
Diane L Damiano, Ph.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
10 Previous Clinical Trials
8,284 Total Patients Enrolled
~40 spots leftby Jul 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top