MedTrace Logo

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

NCT06593886 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-08-05

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Physical Therapy Modalities
  • Brain Injuries

Interventions

DEVICE

BabyG

This involves wearing a harness connected to the overhead device while in a 10 X 10 play area filled with toys and equipment commonly used for infants to promote mobility skills (e.g. crawling and walking). Families can choose to come for 3 30-minute or 2 45-minute sessions per week. Half of the children will participate in the training immediately after enrollment in the study, the others will wait for 12 weeks before starting training. All will receive a comprehensive assessment at 0, 12 and 24 weeks, with additional developmental assessments at 6 and 18 weeks

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Diane L Damiano, Ph.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2024-09-11
Completion
2024-09-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593886 on ClinicalTrials.gov