Cerebral PalsyPhase 2NCT06593886
Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
A Phase 2 study testing BabyG in people with Cerebral Palsy and Physical Therapy Modalities, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 months
- Conditions the study is for
- Cerebral Palsy, Physical Therapy Modalities, Brain Injuries
- What is being tested?
- BabyG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 11 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Conditions
- Cerebral Palsy, Physical Therapy Modalities, Brain Injuries
- Being tested
- BabyG
- Keywords
- Mobility, INFANTS, Robotic Unweighting System
- Medical subject headings
- Cerebral Palsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyGDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group will participate in active motor training at NIH while using the BabyG device immediately Receives: Device: BabyG |
| Group B | Experimental | This group will participate in BabyG training after a 12 week baseline period Receives: Device: BabyG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 months
Secondary outcomes (3)
Changes in brain activation
Changes in brain activation will be correlated w/ changes in Bayley IV and GMFM-66
Measured: 48 months
The absolute and percent change in muscle size of two muscle groups as a result of training
The absolute and percent change in muscle size of two muscle groups as a result of training
Measured: 48 months
Infant age in months and the total training time in minutes
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
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Sep 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Why it stopped: PI left NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Diane L Damiano, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593886
- Sponsor's protocol ID
- 10001897
- Other IDs
- 001897-CC
- Status last verified
- Jul 2025
- First submitted
- 11 Sep 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
- ClinicalTrials.gov ID
- NCT06593886
- Acronym / sponsor ID
- 10001897
- Conditions
- Cerebral Palsy, Physical Therapy Modalities, Brain Injuries
- Keywords
- Mobility, INFANTS, Robotic Unweighting System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left NIH
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: BabyGThis group will participate in active motor training at NIH while using the BabyG device immediately |
| Group B | Experimental | Device: BabyGThis group will participate in BabyG training after a 12 week baseline period |
Who may qualify
- Ages
- 5 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BabyGThis 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 | Device | Group A, Group B |
Primary outcome
Change in the Bayley IV age equivalents and the GMFM-66
Time frame: 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
Time frame: 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.
3 secondary outcomes
Changes in brain activation
Time frame: 48 months
The absolute and percent change in muscle size of two muscle groups as a result of training
Time frame: 48 months
Infant age in months and the total training time in minutes
Time frame: 48 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane L Damiano, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BabyG in people with Cerebral Palsy and Physical Therapy Modalities, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Bayley IV age equivalents and the GMFM-66 (time frame: 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.