Bambini Teens Exoskeleton for Cerebral Palsy

Not yet recruiting at 1 trial location

Overseen By Karen J Nolan, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: COSMO ROBOTICS CO., Ltd

Must not be taking: Baclofen, Botox

Disqualifiers: Severe spasticity, Seizure disorder, others

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

Compensation: Varies

Number of Visits: 8

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Bambini Teens exoskeleton, designed to help children with cerebral palsy improve their walking. Researchers aim to determine its safety and effectiveness for children aged 5 to 14 who can walk with some assistance. Participants will use the exoskeleton during six sessions over about three weeks, and researchers will measure their walking speed and overall mobility. Children with cerebral palsy who can walk 10 meters with help and have normal joint movement may be suitable for this study. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could enhance mobility for children with cerebral palsy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had Botox injections in the past 4 months or have a Baclofen pump, you cannot participate in the trial.

What prior data suggests that the Bambini Teens exoskeleton is safe for children with cerebral palsy?

Research has shown that robotic exoskeletons, such as the Bambini Teens Exoskeleton, are generally safe for children with cerebral palsy. One study found that using the ATLAS 2030 exoskeleton improved children's mobility, reduced muscle tightness, and increased strength, with no major safety issues reported. Another study involving a similar robotic device demonstrated significant improvements in motor skills, balance, and walking for children, with no serious safety concerns noted.

While these studies focused on devices similar to the Bambini Teens Exoskeleton, they suggest that such exoskeletons are generally well-tolerated by children with cerebral palsy. Although each device differs, these findings offer a positive outlook for the safety of the Bambini Teens Exoskeleton. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bambini Teens Exoskeleton is unique because it offers a new way to improve mobility in teens with cerebral palsy through advanced gait training. Unlike traditional therapies, which often rely on physical therapy and medication, this exoskeleton provides direct support and movement assistance to the legs, which can enhance walking ability more effectively. Researchers are excited because this wearable technology allows for more intensive and targeted training sessions, potentially leading to faster and more significant improvements in gait and overall mobility.

What evidence suggests that the Bambini Teens exoskeleton is effective for cerebral palsy?

Studies have shown that robotic exoskeletons can help children with cerebral palsy (CP) improve movement. Research indicates that these devices enhance walking, potentially increasing participation in activities and improving overall quality of life. In this trial, participants will undergo gait training with the Bambini Teens Exoskeleton, designed to assist walking by supporting movements. Previous users of similar exoskeletons experienced better movement control and performance. Early evidence suggests that the Bambini Teens Exoskeleton may lead to faster walking speeds in children with CP. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 5 to 14 with cerebral palsy. They'll use the Bambini Teens exoskeleton for gait training in sessions led by physical therapists. The study checks if it's safe, feasible, and improves walking speed.

Inclusion Criteria

Patients able and willing to comply with study procedures, including follow-up requirements

My joints move well enough for me to walk normally.

I can think clearly and talk well enough to do physical therapy.

Exclusion Criteria

I cannot walk or bear weight fully due to a medical issue.

Patients with pre-existing conditions that cause exercise intolerance

I have skin problems that prevent me from wearing medical devices.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline evaluations to assess initial mobility and other health metrics

1 day

1 visit (in-person)

Treatment

Participants complete 6 gait training sessions using the Bambini Pediatric Exoskeleton, monitored by a licensed physical therapist

3 weeks

6 visits (in-person)

Post-intervention Evaluation

Participants undergo evaluations to assess changes in mobility and other health metrics after the intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bambini Teens Exoskeleton

Trial Overview The Bambini Teens exoskeleton is being tested as a tool to help kids with CP walk better. It involves six 30-minute training sessions over three weeks, plus evaluations before and after the intervention to measure any improvements.

How Is the Trial Designed?

Group I: Bambini Teens Exoskeleton Gait Training Experimental Treatment 1 Intervention

Participants in this arm will receive gait training using the Bambini Teens Exoskeleton. Each participant will complete six training sessions, each lasting 30 minutes, conducted 2-3 times per week over approximately 3 weeks.

Who Is Running the Clinical Trial?

COSMO ROBOTICS CO., Ltd

Lead Sponsor

Trials

3

Recruited

30+

Kessler Foundation

Collaborator

Trials

190

Recruited

11,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07146932

Evaluating the Bambini Teens Exoskeleton for Pediatric ... The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41054899/

Effectiveness of Upper Extremity Exoskeletons in Children ... Recent advances in exoskeleton technology offer promising potential for enhancing rehabilitation outcomes. This systematic review investigates the impact of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0966636222005914

Effectiveness of robotic exoskeletons for improving gait in ... Robotic exoskeletons have the potential to improve the mobility of CP children and may therefore increase community participation and improve quality of life.

4. kesslerfoundation.org kesslerfoundation.org/research/studies/evaluating-bambini-exoskeleton-pediatric-cerebral-palsy

Evaluating the Bambini Exoskeleton for Pediatric Cerebral ... This study aims to assess the safety and effectiveness of the Bambini robotic exoskeleton as a walking training tool for children with cerebral palsy.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cch.70163?af=R

Effectiveness of Upper Extremity Exoskeletons in Children ... Exoskeleton-based interventions improve upper limb movement accuracy, motor control and functional performance in children with cerebral palsy.

6. ctv.veeva.com ctv.veeva.com/study/evaluating-the-bambini-teens-exoskeleton-for-pediatric-cerebral-palsy

Evaluating the Bambini Teens Exoskeleton for Pediatric ... The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8652111/

ATLAS2030 Pediatric Gait Exoskeleton: Changes on Range of ... Conclusion: The ROM, spasticity and strength were improved after RAGT with ATLAS2030 exoskeleton in these children with CP. However, further studies with larger ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821278

Overground Gait Training With a Wearable Robot in ... This randomized clinical trial of 90 children with CP found significant improvements in gross motor function, balance control, and gait pattern

9. mdpi.com mdpi.com/2227-9067/11/12/1500

Usability and Safety of the ATLAS 2030 Robotic Gait ... The purpose of this study was to evaluate the safety and usability of the ATLAS 2030 in children with Cerebral Palsy (CP) and Spinal Muscular Atrophy (SMA).