Knee-Ankle-Foot Brace for Cerebral Palsy

No longer recruiting at 1 trial location

Overseen By Thomas C Bulea, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Seizure history, 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: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of knee-ankle-foot brace, known as EA-KAFO, designed to help children with cerebral palsy walk better. The main goal is to determine if this adjustable brace can improve movement in kids with crouch gait, a common walking issue in cerebral palsy. The trial will explore different brace settings to find the best fit for each child and assess if a universally effective option exists. Children aged 5 to 17 with cerebral palsy who can walk at least 10 feet, with or without assistance, may qualify for this study. As an unphased trial, this study offers children a unique opportunity to potentially enhance their mobility with a new, adjustable brace.

Do I need to stop taking my current medications for the trial?

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 brace is safe for children with cerebral palsy?

Research has shown that the EA-KAFO, a powered brace for the knee, ankle, and foot, is safe for children with cerebral palsy. This brace aids walking by supporting the knees. Studies have found that such devices are usually well-tolerated, with no major reports of serious side effects.

Other studies have tested the brace to confirm its safety and effectiveness. While minor discomfort or skin irritation might occur, serious issues are rare. This suggests that the brace is a safe option for helping children with cerebral palsy improve their walking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EA-KAFO because it offers a novel approach to improving mobility in individuals with cerebral palsy. Unlike traditional braces, which are often passive and rely on fixed structures to provide support, the EA-KAFO incorporates active motorized components and a Powerwalk Knee Exoskeleton. This means it can dynamically assist movement, potentially enhancing walking ability more effectively than standard braces. By allowing each participant to use different configurations of this advanced technology, the EA-KAFO aims to tailor support to individual needs, which could lead to significant improvements in mobility and quality of life.

What evidence suggests that this brace is effective for improving crouch gait in children with cerebral palsy?

Research has shown that exoskeletons, such as the EA-KAFO, can help children with cerebral palsy improve their walking. Studies have found that these devices enable children to walk faster and take longer steps. They also help straighten the knees during walking, reducing crouching. These benefits suggest that the EA-KAFO may allow children with cerebral palsy to walk more easily and comfortably. ^{1 4 6 7 8}

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?

This trial is for children aged 5-17 with movement disorders like CP, muscular dystrophy, spina bifida, or incomplete spinal cord injury who can walk at least 10 feet and follow simple directions. It's also open to healthy volunteers of the same age. Participants should not have other conditions affecting their ability to walk and must not consume caffeine before EEG assessments.

Inclusion Criteria

I am healthy or have a condition affecting my walking due to cerebral palsy, muscular dystrophy, spina bifida, or spinal cord injury.

My foot can almost fully straighten.

I have trouble fully straightening my knee when I walk.

Exclusion Criteria

I can walk short distances unless I have conditions like cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.

I have cerebral palsy and haven't had a seizure in the last year.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Initial Assessment and Casting

Initial assessment and casting for custom leg brace

1 visit

1 visit (in-person)

EA-KAFO Configuration and Practice

Participants will wear their new braces, have them adjusted, and practice with different configurations

2 visits

2 visits (in-person)

Accommodation to Brace Configurations

Participants will accommodate to brace configurations and repeat walking and other steps

2-4 visits

2-4 visits (in-person)

Final Data Collection

Final data collection and assessment of outcomes

1 visit

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

• EA-KAFO

Trial Overview The study tests a new knee-ankle-foot brace (EA-KAFO) designed to improve walking in kids with crouch gait due to CP and similar conditions. Over six visits, participants will undergo motion analysis, muscle activity measurements (EMG), brain wave recordings (EEG), knee testing, walking trials, and custom brace fittings.

How Is the Trial Designed?

Group I: There is a single study arm in this feasibility study. Experimental Treatment 1 Intervention

All participants will be evaluated using the different configurations of the EA-KAFO (see Table 1 in the protocol), which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton. Each subject will serve as their own control to assess the effect of each configuration of the EA-KAFO interventions.

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 study involving nine adults with poliomyelitis showed that using heel-to-toe rocker-soled footwear with knee-ankle-foot orthoses (KAFOs) significantly increased maximum hip joint extension and stride length, suggesting improved gait mechanics.

While the rocker sole adaptation did not significantly increase walking speed or cadence, it reduced hip abduction and adduction, indicating potential benefits for ambulation in patients using KAFOs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of footwear adapted with a multi-curved rocker sole in conjunction with knee-ankle-foot orthoses on walking in poliomyelitis subjects: a pilot study. Mojaver, A., Arazpour, M., Aminian, G., et al.[2018]

In a study of 21 children with spastic diplegic cerebral palsy, both fixed and articulated ankle-foot orthoses (AFOs) improved dorsiflexion at initial contact compared to using shoes alone, indicating enhanced gait mechanics.

Articulated AFOs (AAFOs) were particularly effective, allowing for greater dorsiflexion at terminal stance and preserving plantarflexor power during preswing, making them suitable for children with varying calf spasticity, provided they have adequate passive range of motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of fixed and articulated ankle-foot orthoses on gait patterns in subjects with cerebral palsy. Rethlefsen, S., Kay, R., Dennis, S., et al.[2019]

The clinical evaluation of a new knee-ankle-foot-orthosis (KAFO) was conducted on 120 hemiplegic patients over a six-year period, demonstrating its practical application in improving mobility.

The KAFO features a genucentric knee joint and a specially designed ankle joint, which may enhance the functional outcomes for patients with hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical study of a knee-ankle-foot-orthosis for hemiplegic patients. Morinaka, Y., Matsuo, Y., Nojima, M., et al.[2017]

In a study involving 15 children with spastic diplegic cerebral palsy, wearing either hinged or dynamic ankle-foot orthoses significantly improved gait metrics compared to walking barefoot, indicating that braces can enhance walking ability in these children.

However, there were no significant differences in effectiveness between the two types of braces, suggesting that both options are equally viable for improving ankle movement in children with a jump gait pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brace evaluation in children with diplegic cerebral palsy with a jump gait pattern. Smith, PA., Hassani, S., Graf, A., et al.[2016]

In a study of 26 children with cerebral palsy, those wearing hinged ankle-foot orthoses (HAFO) demonstrated better standing reach, longer stride length, and faster walking speed compared to those wearing solid ankle-foot orthoses (SAFO).

Parents preferred HAFO due to better cost-to-benefit ratios, although overall mobility scores did not significantly differ between the two orthosis types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional Effects of Solid and Hinged Ankle-Foot Orthosis in Children With Cerebral Palsy. Limpaninlachat, S., Prasertsukdee, S., Palisano, RJ., et al.[2023]

In a study of 14 children with spastic diplegic cerebral palsy, different types of ankle-foot orthoses (AFOs) were evaluated, revealing that while AFOs showed abnormal ankle movement, shoes alone approached normal kinematic data.

Most children preferred articulated or posterior leaf-spring braces over solid braces, indicating a potential preference for more flexible support options in improving comfort and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effects of solid, articulated, and posterior leaf-spring ankle-foot orthoses and shoes alone on gait and energy expenditure in children with spastic diplegic cerebral palsy. Smiley, SJ., Jacobsen, FS., Mielke, C., et al.[2022]

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]

Citations

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

A randomized cross-over study protocol to evaluate long ... These methods have shown a range of results demonstrating effectiveness for children with cerebral palsy at improving gait speed [6] and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05746871

NCT05746871 | Safety and Performance of Agilik in CP The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), ...

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

Effectiveness of robotic exoskeletons for improving gait in ... The review suggests that robotic exoskeletons have some beneficial effects on gait in children with CP. Improvements in gait seemed highly dependent on the ...

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

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

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

Researcher View | NCT05726591 | Evaluating Long-term ... It is hypothesized that the 12-week exoskeleton intervention outside the clinic setting will show greater improvements than the standard therapy. Objectives:.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05746871/safety-and-performance-of-agilik-in-cp

Safety and Performance of Agilik in CP | Clinical Research ... The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot ...

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

RePORT RePORTER - National Institutes of Health (NIH) | This is a study of pediatric outpatients split into two participant pools, one with crouch gait from cerebral palsy (CP) and the other knee extension deficiency ...

8. clinconnect.io clinconnect.io/trials/NCT05746871

Safety and Performance of Agilik in CP (NCT05746871) The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), ...