Robotic Walking Device for Child Movement Disorders

Recruiting in Palo Alto (17 mi)

Overseen by Thomas C Bulea, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Uncontrolled seizures, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a robotic exoskeleton that helps children with walking difficulties due to conditions like cerebral palsy or spinal cord injury. The device can either assist or challenge their walking to strengthen muscles and improve movement. Children will use the exoskeleton in different settings to see if it improves their ability to walk. Robotic exoskeletons have been increasingly used in pediatric rehabilitation to assist children with cerebral palsy in improving their walking abilities.

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 data supports the effectiveness of the treatment EA-KAFO, P.REX, Agilik, EA-KAFO for child movement disorders?

Research shows that robotic exoskeletons, similar to EA-KAFO, can improve walking in children with cerebral palsy by enhancing knee extension and overall gait. These devices have been found to be safe, well-tolerated, and effective in improving mobility, which suggests potential benefits for children with movement disorders. ^{1 2 3 4 5}

Is the robotic walking device safe for children with movement disorders?

Research shows that robotic exoskeletons, like those used for children with cerebral palsy, are generally safe and well-tolerated. In studies, children were able to walk independently with the device, and no significant adverse events were reported. ^{1 5 6 7 8}

How is the EA-KAFO treatment different from other treatments for child movement disorders?

The EA-KAFO treatment is unique because it is a wearable robotic exoskeleton that helps children with cerebral palsy improve their walking by providing knee extension assistance during specific parts of the walking cycle, unlike traditional therapies that may require invasive surgery or are limited to short-term clinic-based programs. ^{1 2 9 10 11}

Research Team

Thomas C Bulea, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• EA-KAFO (Robotic Exoskeleton)

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.

Participant Groups

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 Canada for the following indications:

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+

Pius Aiyelawo

National Institutes of Health Clinical Center (CC)

Chief Executive Officer

MPA, FACHE

Dr. Karen Frank

National Institutes of Health Clinical Center (CC)

Chief Medical Officer

MD

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

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

A lower-extremity exoskeleton improves knee extension in children with crouch gait from cerebral palsy. [2023]

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

WAKE-Up Exoskeleton to Assist Children With Cerebral Palsy: Design and Preliminary Evaluation in Level Walking. [2018]

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

Exoskeleton Assistance Improves Crouch during Overground Walking with Forearm Crutches: A Case Study. [2023]

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

Improved gait parameters after robotic-assisted locomotor treadmill therapy in a 6-year-old child with cerebral palsy. [2008]

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

A Robotic Exoskeleton for Treatment of Crouch Gait in Children With Cerebral Palsy: Design and Initial Application. [2021]

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

Safety of robotic-assisted treadmill therapy in children and adolescents with gait impairment: a bi-centre survey. [2010]

7. England pubmed.ncbi.nlm.nih.gov

Kinematic and muscle demand similarities between motor-assisted elliptical training and walking: Implications for pediatric gait rehabilitation. [2018]

8. United States 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? [2019]

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

Design and preliminary evaluation of a multi-robotic system with pelvic and hip assistance for pediatric gait rehabilitation. [2018]

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

Promoting step responses of children with multiple disabilities through a walker device and microswitches with contingent stimuli. [2018]

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

Pediatric anklebot. [2012]