BabyG Harness for Cerebral Palsy

Overseen By Jesse H Matsubara

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institutes of Health Clinical Center (CC)

Must not be taking: Baclofen

Disqualifiers: Orthopedic, Neuromuscular, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 45

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called BabyG, a harness designed to help babies with cerebral palsy (CP) move safely. The goal is to determine if BabyG can support babies in practicing movements like rolling, sitting, crawling, and walking, while also catching them if they fall. Infants with CP or those at high risk for CP who can push up on their arms or show interest in moving might be suitable candidates. Participants will use the harness for 12 weeks and undergo tests to assess their progress. As a Phase 2 trial, this research measures how well the BabyG device works in an initial, smaller group of babies, offering a chance to contribute to important advancements in CP care.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking baclofen to reduce hypertonia (muscle stiffness). If your child is on this medication, they would need to stop taking it to participate.

What prior data suggests that the BabyG harness is safe for infants with cerebral palsy?

Research has shown that the BabyG harness is both practical and safe for children with cerebral palsy. Testing for home use supports its safety in everyday situations. The BabyG is a soft harness connected to a robotic system, designed to support a child's weight and prevent falls.

Previous studies did not report any major side effects, indicating that the device is generally well-accepted. Children use the harness during sessions to help improve their movement skills. This focus on safety and real-world use may reassure parents considering this trial for their child. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cerebral palsy, which often involve medications or surgical interventions, the BabyG harness offers a unique approach by using a wearable device to promote active motor training. Researchers are excited about BabyG because it provides a hands-on method that may enhance motor skills through guided movement and muscle engagement. This device is particularly promising as it allows for an immersive, immediate intervention strategy that could potentially accelerate improvements in motor function, offering a new avenue of hope for children with cerebral palsy.

What evidence suggests that the BabyG harness is effective for cerebral palsy?

Research has shown that robotic-assisted gait training (RAGT), such as the BabyG harness, can help children with cerebral palsy improve walking, balance, and movement skills. Studies indicate that robotic-assisted treadmill therapy enhances walking and standing abilities in children and teenagers with this condition. In this trial, participants in Group A will immediately use the BabyG system, which employs a soft harness to support some of the infant's weight, allowing free and safe movement in a play area. This setup aids in improving posture and motor development in infants. Group B will begin BabyG training after a 12-week baseline period. The harness creates a supportive environment that encourages infants to practice movements like rolling, sitting, crawling, and walking. These findings suggest that BabyG may effectively promote motor skills in infants with cerebral palsy. ^{1 2 3 5 6}

Who Is on the Research Team?

Diane L Damiano, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Availability to return to NIH CC with parent or caregiver for training and assessment sessions.

My child is between 5 to 18 months old, adjusted for early birth if applicable.

I can push myself up with my arms or show interest in moving around by myself.

Exclusion Criteria

My seizures are not controlled by medication.

I have had surgery on my arms or legs in the last 6 months.

I am not enrolled in any other clinical trials that involve motor training or could affect this study's results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a 12-week baseline period without BabyG training

12 weeks

Regular assessments

Treatment

Participants receive 12 weeks of mobility training with the BabyG robotic unweighting system

12 weeks

Weekly sessions (either two 45-minute sessions or three 30-minute sessions)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BabyG

Trial Overview 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.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

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

Group II: Group A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Published Research Related to This Trial

The portable body weight support system (PBWSS) was used effectively by a family for an average of 4 days a week, helping an infant with Down syndrome improve her mobility during training sessions.

Frequent use of the PBWSS allowed the infant to practice motor skills in a natural environment, suggesting that this method could positively influence her overall development, although more research with larger samples is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Home Mobility Training With a Portable Body Weight Support System of an Infant With Down Syndrome. Kokkoni, E., Stoner, T., Galloway, JC.[2021]

A novel portable body weight support system (PBWSS) was successfully used by 16 infants in both home and lab settings, with parents reporting positive behavioral changes in their infants, including the initiation of new movements.

Parents found the device easy to set up and use, expressed satisfaction with its design, and suggested improvements for comfort, indicating strong acceptability and potential for ongoing use in promoting mobility in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centred assistive technology assessment of a portable open-area body weight support system for in-home use. Kokkoni, E., Galloway, JC.[2021]

Robotic exoskeletons can significantly improve gait in children with cerebral palsy by enhancing walking speed, reducing the metabolic cost of walking, and promoting normal ankle function, as shown in a systematic review of 13 studies.

The effectiveness of these exoskeletons is maximized when there is careful optimization of torque and adequate practice time for each child, highlighting the need for future studies to focus on larger controlled trials with sufficient adaptation periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of robotic exoskeletons for improving gait in children with cerebral palsy: A systematic review. Hunt, M., Everaert, L., Brown, M., et al.[2023]

In a study involving 41 nonambulatory children with cerebral palsy, intramuscular botulinum toxin A (BoNT-A) injections did not increase the risk of moderate or serious adverse events compared to a sham procedure, indicating its safety for this population.

The study found that even after multiple injections of BoNT-A, there was no significant difference in the incidence of adverse events, suggesting that repeated treatments are also safe for children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy. Edwards, P., Sakzewski, L., Copeland, L., et al.[2017]

The use of a rigid pelvic stabilizer (RPS) significantly reduced the need for caregiver assistance in 30% of functional tasks for children with cerebral palsy, compared to a traditional lap belt.

During the intervention phase with the RPS, five out of six children required less frequent repositioning, indicating improved stability and independence while performing tasks from their wheelchair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a wheelchair-mounted rigid pelvic stabilizer on caregiver assistance for children with cerebral palsy. Rigby, P., Reid, D., Schoger, S., et al.[2019]

Robotic-assisted gait training therapy (RAGT) significantly improves dynamic balance control and locomotor functions in children with bilateral spastic cerebral palsy, as evidenced by kinematic data and Gross Motor Function Measure test results after 20 sessions of treatment.

Children receiving RAGT demonstrated enhanced upper body control and improved lower limb movement strategies compared to a control group that only received standard physiotherapy, highlighting the effectiveness of RAGT in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted gait training improves walking abilities in diplegic children with cerebral palsy. Wallard, L., Dietrich, G., Kerlirzin, Y., et al.[2018]

A meta-analysis of eight studies involving 188 individuals with cerebral palsy found that robotic gait training did not significantly improve mobility compared to standard care methods like physical therapy.

The study assessed various mobility outcomes, including walking speed and endurance, and concluded that tethered robotic devices do not offer additional benefits over traditional treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is robotic gait training effective for individuals with cerebral palsy? A systematic review and meta-analysis of randomized controlled trials. Conner, BC., Remec, NM., Lerner, ZF.[2023]

Robotic-assisted gait training (RAGT) significantly improves walking distance in children with cerebral palsy (CP), with these improvements maintained over the long term, as shown in a systematic review of seven studies.

While RAGT showed large clinical effects on gait speed and functionality, the specific results for gait speed were not statistically significant, indicating that while RAGT is beneficial, its impact on speed may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of assisted robotic gait training in walking distance, speed, and functionality are maintained over the long term in individuals with cerebral palsy: a systematic review and meta-analysis. Volpini, M., Aquino, M., Holanda, AC., et al.[2022]

The CPWalker robotic platform showed potential to improve gait parameters in children with Cerebral Palsy, with significant changes observed in spatio-temporal parameters and pelvic angles during rehabilitation.

While the intervention did not significantly affect symmetry indexes, it indicated a reduction in pelvic angle ranges and propulsion, suggesting that the CPWalker may enhance muscular strength and gait patterns over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of biomechanical gait parameters of patients with Cerebral Palsy at three different levels of gait assistance using the CPWalker. Aycardi, LF., Cifuentes, CA., Múnera, M., et al.[2020]

The untethered ankle exoskeleton significantly reduced the metabolic cost of walking by 19% in children and young adults with cerebral palsy, indicating improved walking efficiency.

The device was designed to minimize added weight and provided real-time assistance during walking, showing promise for enhancing mobility and quality of life in individuals with gait pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Untethered Ankle Exoskeleton Improves Walking Economy in a Pilot Study of Individuals With Cerebral Palsy. Lerner, ZF., Gasparri, GM., Bair, MO., et al.[2023]

In a study of nonambulatory children with cerebral palsy (CP), it was found that spastic CP patients experience a faster increase in hip subluxation compared to dyskinetic CP, with GMFCS level V patients showing consistently higher migration percentages.

The use of weight relief walking and standing assistive devices, along with targeted botulinum injections, was effective in reducing the progression of hip subluxation, highlighting their importance in managing nonambulatory CP patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip subluxation in Italian cerebral palsy children and its determinants: a retrospective cohort study. Faccioli, S., Sassi, S., Ferrari, A., et al.[2023]

The pilot study involving three children with bilateral spastic cerebral palsy demonstrated that overground robot-assisted gait training (RAGT) using a torque-assisted exoskeleton significantly improved gross motor function and walking performance after 17-20 training sessions.

All participants showed positive outcomes, including increased walking speed and endurance, with one child achieving independent walking with a platform walker, indicating that this intervention is both safe and effective even for those with severe motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy. Kim, SK., Park, D., Yoo, B., et al.[2021]

The study involved 88 children, including 28 with cerebral palsy using adjustable splint-assisted ankle-foot orthoses (AFO), and showed that this method significantly improved the heel/forefoot ratio, indicating a reduction in equinus deformity over 12 months.

In comparison, children using static AFOs showed less improvement, suggesting that the adjustable splint-assisted AFO is a more effective treatment option for managing equinus deformities in children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatment for equinus deformity in children with cerebral palsy using an adjustable splint-assisted ankle-foot orthosis. Chen, W., Liu, X., Pu, F., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06593886

Promoting Upright Mobility in Infants With Cerebral Palsy ... 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 ...

2. app.trialscreen.org app.trialscreen.org/trials/phase-2-promoting-upright-mobility-infants-cerebral-palsy-using-robotic-trial-nct06593886

Promoting Upright Mobility in Infants With Cerebral Palsy Study Goals. The study aims to assess the effectiveness of a robotic unweighting system called BabyG in improving upright mobility, posture ...

3. withpower.com withpower.com/trial/phase-2-brain-injuries-8-2024-521e6?condition=brain+injury&overallStatus=Recruiting&hasNoPlacebo=false

BabyG Harness for Cerebral Palsy · Info for Participants Research on robotic-assisted gait training (RAGT) for children with cerebral palsy shows that it can improve walking abilities, balance, and motor functions.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S109037981000022X

Robotic-assisted treadmill therapy improves walking and ... Original article. Robotic-assisted treadmill therapy improves walking and standing performance in children and adolescents with cerebral palsy.

5. cpresource.org cpresource.org/topic/clinical-trials-geographic-location

Clinical Trials by Geographic Location Purpose: To evaluate the effects of 12 weeks of mobility training while in a computer-controlled (robotic) unweighting system (BabyG) on motor development rate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8453102/

Pilot evaluation of changes in motor control after wearable ... The findings from this study suggest that ankle exoskeleton resistance therapy shows promise for rapidly improving neuromuscular control for children with CP, ...