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

NCT06593886 | Withdrawn Phase 2 FDA Device

• 2 other identifiers: 10001897001897-CC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Physical Therapy Modalities; Brain Injuries

Keywords

Mobility; INFANTS; Robotic Unweighting System

Outcome Measures

Primary Outcomes (2)

• Change in the Bayley IV age equivalents and the GMFM-66

  Compare change in the Bayley IV age equivalents and the GMFM-66 during the training and no-training periods.

  48 months

• Changes in EEG brain activity

  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.

  48 months

Secondary Outcomes (3)

• Changes in brain activation

  48 months

• The absolute and percent change in muscle size of two muscle groups as a result of training

  48 months

• Infant age in months and the total training time in minutes

  48 months

Study Arms (2)

Group A

EXPERIMENTAL

This group will participate in active motor training at NIH while using the BabyG device immediately

Device: BabyG

Group B

EXPERIMENTAL

This group will participate in BabyG training after a 12 week baseline period

Device: BabyG

Interventions

BabyG DEVICE

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

Group A; Group B

Eligibility Criteria

• Age: 5 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• At least 5 months (adjusted for prematurity for those 37 weeks of gestation or less and is based on their due date) and no more than 18 months of age at enrollment
• A diagnosis of CP or high risk of CP
• Ability to push up on extended arms in prone for at least 10 seconds or demonstrates an interest in moving from one place to another by rolling, scooting or other means
• Availability to return to NIH CC with parent or caregiver for training and assessment sessions.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Secondary orthopedic, neuromuscular or cardiovascular conditions unrelated to CP that would impede mobility such as hip dysplasia, clubfeet, uncorrected heart defect that affects exertion levels, brachial plexus palsy, among others
• History of surgery to the upper or lower extremities in the past 6 months
• Seizure disorder that is not controlled by medication
• Currently taking baclofen to reduce hypertonia
• Enrolled in another clinical trial during the study period that involves motor training or other intervention that could influence the outcomes of this study
• Walk independently for 10 steps on a consistent basis with or without handheld assistive devices.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Diane L Damiano, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 11, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

US (1)