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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the BabyG Harness for Cerebral Palsy treatment?

Research on robotic-assisted gait training (RAGT) for children with cerebral palsy shows that it can improve walking abilities, balance, and motor functions. Studies indicate that RAGT helps children walk faster and farther, with better balance and less energy use, suggesting that similar robotic systems like the BabyG Harness could be effective. ^{1 2 3 4 5}

Is the BabyG Harness for Cerebral Palsy safe for use in humans?

The BabyG Harness, also known as a portable body weight support system, has been studied for in-home use and is considered feasible and safe for children with cerebral palsy, even those with severe motor impairments. ^{2 6 7 8 9}

How does the BabyG Harness treatment for cerebral palsy differ from other treatments?

The BabyG Harness is unique because it is a portable body weight support system designed for in-home use, allowing for early, high-dose, and variable movement training outside of clinical settings. This makes it more accessible and manageable for parents compared to traditional treatments that often require clinical environments. ^{8 10 11 12 13}

Research Team

Diane L Damiano, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a wheelchair-mounted rigid pelvic stabilizer on caregiver assistance for children with cerebral palsy. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Robotic-assisted gait training improves walking abilities in diplegic children with cerebral palsy. [2018]

4. England 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. [2023]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Hip subluxation in Italian cerebral palsy children and its determinants: a retrospective cohort study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Conservative treatment for equinus deformity in children with cerebral palsy using an adjustable splint-assisted ankle-foot orthosis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

In-Home Mobility Training With a Portable Body Weight Support System of an Infant With Down Syndrome. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of robotic exoskeletons for improving gait in children with cerebral palsy: A systematic review. [2023]

12. England 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. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

An Untethered Ankle Exoskeleton Improves Walking Economy in a Pilot Study of Individuals With Cerebral Palsy. [2023]