Ankle Exoskeletons for Cerebral Palsy

Overseen By Zach Lerner, PhD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northern Arizona University

Disqualifiers: Neurological, Musculoskeletal, Cardiorespiratory, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of ankle exoskeletons in improving walking for people with cerebral palsy in their daily lives. Participants will walk either with the ankle exoskeleton or under normal conditions without it to determine if the device makes a difference. It suits those with cerebral palsy who can walk for at least 20 minutes, with or without assistance. The trial seeks to assess whether wearing this device can enhance walking ability in community settings. As an Early Phase 1 trial, this research focuses on understanding how the ankle exoskeleton functions in people, offering participants a chance to be among the first to experience this innovative device.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ankle exoskeleton is safe for individuals with cerebral palsy?

Research has shown that ankle exoskeletons are generally safe and comfortable for users. For instance, one study found that training with these devices was both safe and comfortable for participants. Another study demonstrated that people with cerebral palsy could easily adapt to using the exoskeleton on different surfaces without major problems. Most users did not experience significant negative effects while using the device.

Although this trial is in the early stages, these findings suggest that using an ankle exoskeleton could safely improve walking. However, more research is needed to fully understand any long-term effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ankle exoskeletons for cerebral palsy because they offer a unique way to assist walking by providing mechanical support directly to the ankles. Unlike standard treatments, which often include physical therapy, medication, or surgery, the exoskeletons aim to enhance mobility through wearable technology that can adapt to the user's movement. This approach not only potentially improves walking efficiency but also encourages more natural movement patterns, which could significantly enhance the quality of life for individuals with cerebral palsy.

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

Research has shown that ankle exoskeletons, which participants in this trial may use, can help people with cerebral palsy move better. Studies have found that these exoskeletons can increase walking speed and improve walking efficiency. For instance, one study discovered that participants walked an average of 42 meters farther in a six-minute walk test when using an ankle exoskeleton. These devices support the ankle, making movement easier. Overall, early findings suggest that ankle exoskeletons might make walking less tiring and more efficient for those with cerebral palsy. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with cerebral palsy who can walk at least 20 minutes with or without help. They must fit into the exoskeleton device and not have knee issues while walking. Participants should be able to say yes to joining, or if non-verbal, show agreement through gestures interpreted by parents.

Inclusion Criteria

I can say 'yes' to join, or my parents can interpret my gestures if I can't speak.

I can walk with or without walking aids or assistance.

I can use a walking aid without my knee bending backward.

Exclusion Criteria

I have no health issues, besides cerebral palsy, affecting my ability to walk.

Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Device Fitting and Initial Assessment

Participants undergo consent, history/physical/activity questionnaire, and orthotic device fitting. Initial walking tests with and without the device are conducted.

1-2 hours

1 visit (in-person)

Independent Walking Practice

Participants complete a pre-determined walking route every day for 1 week with or without ankle exoskeleton assistance.

1 week

Washout Period

Participants undergo a washout period before switching conditions.

2-6 weeks

Second Walking Practice and Assessment

Participants complete another week of community walking practice under the remaining condition, followed by pre- and post-assessments.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ankle Exoskeleton

Trial Overview

The study is testing a wearable ankle exoskeleton against normal walking to see how it helps in daily life for those with cerebral palsy. It's a practical test of the technology outside of lab conditions.

How Is the Trial Designed?

Group I: Exoskeleton Walking Experimental Treatment 1 Intervention

Walking with ankle exoskeleton assistance

Group II: Normal walking Placebo Group 1 Intervention

Walking under normal conditions (no exoskeleton)

Ankle Exoskeleton is already approved in United States for the following indications:

Approved in United States as Ankle Exoskeleton for:

• Mobility assistance for individuals with cerebral palsy

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

Published Research Related to This Trial

A clinical feasibility study involving five individuals with cerebral palsy demonstrated that using a novel untethered ankle exoskeleton significantly improved gait mechanics, including a clinically meaningful 14.4° improvement in lower-extremity flexion deformity.

The powered ankle assistance not only enhanced biological function, leading to a 19% reduction in metabolic cost of transport, but also increased ankle power by 44%, suggesting it could be a valuable tool for improving mobility in individuals with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Battery-Powered Ankle Exoskeleton Improves Gait Mechanics in a Feasibility Study of Individuals with Cerebral Palsy. Lerner, ZF., Harvey, TA., Lawson, JL.[2019]

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 use of battery-powered ankle exoskeleton assistance significantly improved walking distance in the six-minute walk test by an average of 42 meters compared to walking without the device, which is clinically meaningful for children and young adults with cerebral palsy.

While the exoskeleton improved walking performance, it did not enhance walking efficiency, indicating that while users can walk further, they may not be using less energy to do so.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ankle Exoskeleton Assistance Increases Six-Minute Walk Test Performance in Cerebral Palsy. Conner, B., Orekhov, G., Lerner, Z.[2023]

The Rutgers Ankle CP, a new rehabilitation device, was tested on a 7-year-old boy with cerebral palsy over 36 sessions, showing significant improvements in ankle strength, motor control, and gait function.

The training led to enhanced overall function and quality of life, surpassing minimal clinical importance, suggesting that this device could be beneficial for children with cerebral palsy, although further studies with more participants are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ankle control and strength training for children with cerebral palsy using the Rutgers Ankle CP: a case study. Cioi, D., Kale, A., Burdea, G., et al.[2013]

Ankle foot orthoses (AFOs) significantly improve gait parameters in children with cerebral palsy, with notable increases in stride length and ankle dorsiflexion, particularly in those with hemiplegia.

The study involved 56 children with cerebral palsy, showing that AFOs enhanced walking stability and symmetry, with a tripling of patients achieving symmetry during double support phases, indicating effective support for mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of community-prescribed ankle-foot orthoses on gait parameters in children with spastic cerebral palsy. Hayek, S., Hemo, Y., Chamis, S., et al.[2021]

In a study involving seven participants with cerebral palsy, the use of an untethered ankle exoskeleton providing plantar-flexor assistance did not significantly improve dynamic stability during walking, whether unperturbed or perturbed.

Despite the lack of impact on stability, the study highlights the need for further research in real-world settings to explore the potential benefits of exoskeletons for mobility in individuals with movement disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Ankle Exoskeleton Assistance Impair Stability During Walking in Individuals with Cerebral Palsy? Harvey, TA., Conner, BC., Lerner, ZF.[2022]

The study involving 7 individuals with cerebral palsy demonstrated that using an untethered ankle exoskeleton significantly improved ankle mechanics during incline walking, with a 7° increase in peak ankle dorsiflexion and an 8% increase in total ankle plantarflexor moment.

The exoskeleton also reduced muscle activity in key muscles during walking, indicating that it can assist with mobility by decreasing the effort required from the user's muscles, while also enhancing performance during stair ascent with a 17% increase in ankle moment and a 40% increase in knee extensor moment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Ankle Exoskeleton Assistance Affects the Mechanics of Incline Walking and Stair Ascent in Cerebral Palsy. Fang, Y., Lerner, ZF.[2022]

The lightweight untethered ankle exoskeleton demonstrated a significant 9.9% reduction in metabolic power during inclined walking in unimpaired users, indicating improved walking efficiency.

Individuals with cerebral palsy were able to ascend significantly more floors (38.4% more) without increasing metabolic power or perceived exertion, showcasing the device's potential to enhance mobility in users with walking impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and performance validation of an ultra-lightweight and versatile untethered robotic ankle exoskeleton. Orekhov, G., Fang, Y., Cuddeback, CF., et al.[2022]

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]

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