Robotic Walking Device for Child Movement Disorders

Overseen By Thomas C Bulea, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Uncontrolled seizures, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a robotic device worn on the legs can improve walking in children with certain movement disorders. The device, called an exoskeleton, offers a new method to train walking for children with conditions such as cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injuries. Participants will use the device, known as EA-KAFO, in various settings to observe changes in their walking. Children aged 3 to 17 who have difficulty walking due to knee joint issues may be suitable for this study. As an unphased trial, this study provides a unique opportunity for children to potentially enhance their mobility with innovative technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this robotic walking device is safe for children with movement disorders?

Research shows that robotic exoskeletons, like the one tested in this study, are safe and effective for children with movement problems. These devices aim to improve mobility, and past studies have demonstrated their effectiveness. Although specific results from this study are not yet available, similar devices have shown positive outcomes without major safety concerns. This suggests they could benefit children with conditions such as cerebral palsy, spina bifida, and muscular dystrophy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EA-KAFO treatment for child movement disorders because it involves a cutting-edge robotic walking device. Unlike traditional methods like physical therapy and standard orthotic devices that mainly focus on passive support, this device actively assists in walking. Its innovative design aims to improve mobility and independence by providing dynamic movement support, potentially leading to better outcomes and faster progress for children. This approach represents a significant leap forward in how we can help children with movement challenges.

What evidence suggests that this robotic device is effective for improving walking ability in children with gait disorders?

This trial will evaluate the effectiveness of a robotic walking device, EA-KAFO, for children with movement disorders. Studies have shown that robotic exoskeletons can improve walking in children with conditions like cerebral palsy and spinal cord injury. Research indicates that these devices can strengthen muscles and help children walk faster and more steadily. Specifically, one study found that children using the robotic device could straighten their knees better, aiding in standing up straighter while walking. Initial findings also suggest the device can help children take bigger steps. These improvements can ease daily activities and enhance overall mobility. Participants in this trial will be divided into two groups: Group A will receive the 12-week study intervention with the EA-KAFO device, while Group B will serve as a control group for the first 12 weeks. ^{1 3 4 5 6}

Who Is on the Research Team?

Thomas C Bulea, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

Children aged 3-17 with knee-related gait disorders from cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury. They must be able to walk at least 10 feet and commit to the study's duration. Pregnant individuals or those with other conditions affecting walking ability are excluded.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.

I am between 3 and 17 years old.

Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.

Exclusion Criteria

I have no health issues affecting my walking except for cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.

I have not had uncontrolled seizures in the last year.

Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

In-lab Training and Accommodation

Participants undergo in-lab training and accommodation with the exoskeleton to ensure proper fit and operation

12 weeks

Multiple visits (in-person)

Exoskeleton Intervention

Participants use the exoskeleton at home for 1 hour per day, 5 days per week

12 weeks

Home-based

Standard Therapy

Participants continue with their standard therapy regimen

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• EA-KAFO

Trial Overview The trial tests a pediatric robotic exoskeleton (P.REX/Agilik) designed for children with movement disorders. It involves three phases: standard therapy continuation, lab-based exoskeleton training with customized fitting, and home use of the device for walking practice.

How Is the Trial Designed?

Group I: Group A Experimental Treatment 1 Intervention

12 weeks-study intervention

Group II: Group B Active Control 1 Intervention

12 weeks the control first.

EA-KAFO is already approved in United States, Canada for the following indications:

Approved in United States as Agilik for:

• Cerebral Palsy
• Spina Bifida
• Muscular Dystrophy
• Incomplete Spinal Cord Injury

Approved in Canada as Agilik for:

• Cerebral Palsy
• Knee Extension Deficiency

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 multi-robot system designed to assist children with developmental delays in learning to walk includes a pelvic module and a hip module, providing customizable support for gait with high precision in motion tracking (2 mm RMS error for the pelvic module and <0.1 mm RMS error for the hip module).

Both modules can operate independently or together, allowing for flexible configurations that adapt to the specific needs of each child, making the system highly effective for personalized gait assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and preliminary evaluation of a multi-robotic system with pelvic and hip assistance for pediatric gait rehabilitation. Park, EJ., Kang, J., Su, H., et al.[2018]

The study demonstrated that using a walker device combined with microswitches and preferred stimuli effectively increased locomotion in two children with severe disabilities, showing positive results in their step responses during the intervention phases.

This research replicates previous pilot studies, reinforcing the idea that such interventions can motivate children with disabilities to engage in more movement, which is crucial for their development and social interaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting step responses of children with multiple disabilities through a walker device and microswitches with contingent stimuli. Lancioni, GE., De Pace, C., Singh, NN., et al.[2018]

In a study of 89 children and adolescents undergoing robotic-assisted treadmill therapy, 42.7% experienced mild adverse events, primarily skin irritation and muscle pain, but no severe side effects were reported.

The therapy was deemed safe overall, allowing for extended gait training periods despite some patients experiencing minor issues that occasionally limited their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of robotic-assisted treadmill therapy in children and adolescents with gait impairment: a bi-centre survey. Borggraefe, I., Klaiber, M., Schuler, T., et al.[2010]

A powered exoskeleton designed for knee extension assistance showed promising results in improving knee extension by 18.1° and total knee range of motion by 21.0° in a six-year-old boy with cerebral palsy and crouch gait.

The device did not significantly reduce knee extensor muscle activity, suggesting that the child was able to use his muscles effectively while benefiting from the exoskeleton, indicating its potential for long-term gait training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Robotic Exoskeleton for Treatment of Crouch Gait in Children With Cerebral Palsy: Design and Initial Application. Lerner, ZF., Damiano, DL., Park, HS., et al.[2021]

The WAKE-up exoskeleton, designed for pediatric patients with neurological conditions like Cerebral Palsy, effectively assists ankle and knee mobility during walking, demonstrating its potential for rehabilitation.

In pre-clinical tests with children, including those with CP, the device provided appropriate torque assistance, particularly improving foot landing during the gait cycle, which is crucial for effective locomotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WAKE-Up Exoskeleton to Assist Children With Cerebral Palsy: Design and Preliminary Evaluation in Level Walking. Patane, F., Rossi, S., Del Sette, F., et al.[2018]

A 3-week trial of robotic-assisted treadmill therapy in a 6-year-old boy with bilateral spastic cerebral palsy showed significant improvements in walking function, speed, and endurance.

The therapy is thought to enhance spinal network modulation and muscle energy consumption, suggesting that robotic interventions could be beneficial for children with central gait impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved gait parameters after robotic-assisted locomotor treadmill therapy in a 6-year-old child with cerebral palsy. Borggraefe, I., Meyer-Heim, A., Kumar, A., et al.[2008]

A wearable exoskeleton was found to be safe and well-tolerated by ambulatory children with cerebral palsy (CP), effectively reducing crouch gait during walking, which is a common and debilitating issue in CP.

The exoskeleton improved knee extensor muscle activity and showed postural improvements in six out of seven participants, with benefits increasing over the course of a multiweek trial, suggesting its potential as a long-term treatment strategy for enhancing mobility in children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lower-extremity exoskeleton improves knee extension in children with crouch gait from cerebral palsy. Lerner, ZF., Damiano, DL., Bulea, TC.[2023]

The Pedi-ICARE, a modified motor-assisted elliptical trainer, allows children as young as three years old with physical disabilities to engage in effective walking and fitness training, showing strong similarities in movement patterns to natural walking.

The device's ability to adjust motor assistance levels enables tailored muscle demands, making it versatile for various children's abilities and promoting task-specific training to improve walking skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic and muscle demand similarities between motor-assisted elliptical training and walking: Implications for pediatric gait rehabilitation. Burnfield, JM., Cesar, GM., Buster, TW., et al.[2018]

A case study of a wearable robotic exoskeleton for a child with cerebral palsy (CP) at GMFCS III showed that the device effectively synchronized assistance to different phases of the gait cycle, leading to improved knee extension during walking with crutches.

The exoskeleton provided assistance without reducing muscle activity, suggesting that state-based control for robotic assistance could be a promising rehabilitation strategy for children with CP who have limited mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton Assistance Improves Crouch during Overground Walking with Forearm Crutches: A Case Study. Bulea, TC., Chen, J., Damiano, DL.[2023]

The alpha-prototype of a novel pediatric ankle robot was developed to assist in the recovery of ankle function in children aged 5 to 8 years with cerebral palsy, indicating a targeted approach to rehabilitation for this specific age group and condition.

Pilot testing of the robot will begin at multiple children's hospitals, and initial data with healthy children suggests that the device has promising characteristics for effective therapy, following established design principles for robotic rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric anklebot. Krebs, HI., Rossi, S., Kim, SJ., et al.[2012]

In a study of 76 children with cerebral palsy, those using seating systems with medial knee support (MKS) experienced a significant increase in hip displacement, as measured by the Reimer's migration index, from 26.89% to 44.18%.

The rate of hip displacement progression was notably higher in the MKS group at 14.72% per year compared to 7.82% per year in the control group, suggesting that MKS may worsen hip displacement in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Seating Systems With a Medial Knee Support Really Helpful for Hip Displacement in Children With Spastic Cerebral Palsy GMFCS IV and V? Kim, IS., Park, D., Ko, JY., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11230531/

A randomized cross-over study protocol to evaluate long ... A study of ambulatory children with bilateral cerebral palsy found decreased volition in motor control and muscle activation of the legs when ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05726591/evaluating-long-term-use-of-a-pediatric-robotic-exoskeleton-prex-agilik-to-improve-gait-in-children-with-movement-disorders

Evaluating Long-term Use of a Pediatric Robotic ... This randomized crossover trial will determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical ...

3. reporter.nih.gov reporter.nih.gov/search/IOgP0rajz0CjrOoZEV2lVw/project-details/11194692

Evaluating a pediatric exoskeleton to improve ... - NIH RePORTER The primary outcome measure is peak knee extension during midstance during walking, with secondary outcome measures including gait speed, step length, knee ...

4. withpower.com withpower.com/trial/phase-muscular-dystrophies-1-2023-6cec8?condition=spina+bifida&hasNoPlacebo=false&overallStatus=Recruiting

Robotic Walking Device for Child Movement Disorders This trial tests a robotic exoskeleton that helps children with walking difficulties due to conditions like cerebral palsy or spinal cord injury.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05726591?tab=table

Researcher View | NCT05726591 | Evaluating Long-term ... To evaluate changes in muscle strength and gait speed following longitudinal intervention with robotic exoskeleton in children with crouch gait from CP or knee ...

6. reporter.nih.gov reporter.nih.gov/search/Z_5c2BimP0uAkXMXFW5R2g/project-details/11194693

Project Details - NIH RePORTER The aim of the study is to investigate the safety and effectiveness of a robotic exoskeleton for overground gait training targeting improvements to knee angle ...