Knee-Ankle-Foot Brace for Cerebral Palsy

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Thomas C Bulea, Ph.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Seizure history, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: - Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group. Objective: - To evaluate a new brace to improve crouch gait in children with CP. Eligibility: * Children 5 17 years old with CP. * Healthy volunteers 5 17 years old. Design: * All participants will be screened with medical history and physical exam. * Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below. * Participants with CP will have 6 visits. * Visit 1: \<TAB\>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement. \<TAB\>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity. \<TAB\>3. Participants knee movement will be tested. \<TAB\>4. Participants will walk 50 meters. \<TAB\>5. Participants legs will be cast to make custom braces. * Visit 2: * Participants will wear their new braces and have them adjusted. * Steps 1 3 will be repeated. * EEG: Small metal discs will be placed on the participants scalp. They record brain waves. * Participants will have electrical stimulation of their knees and practice extending them. * Participants will take several walks with the braces in different settings. * Visits 3 5: participants will repeat the walking and some other steps from visit 2. * Visit 6 will repeat visit 2.

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 data supports the effectiveness of the treatment EA-KAFO, P.REX, Agilik, EA-KAFO for cerebral palsy?

Research shows that different types of ankle-foot orthoses (braces) can improve walking patterns in children with cerebral palsy, although no single type is proven to be the best. Articulated braces, which allow some movement, are often preferred by children and can help maintain power in the foot during walking. ^{1 2 3 4 5}

What makes the EA-KAFO treatment unique for cerebral palsy?

The EA-KAFO (P.REX, Agilik) is a unique treatment for cerebral palsy as it combines a knee-ankle-foot brace with advanced joint designs that may offer improved support and mobility compared to traditional braces. This treatment is particularly novel because it incorporates a genucentric knee joint and a similarly designed ankle joint, which are not typically found in standard braces. ^{1 2 4 6 7}

Research Team

Thomas C Bulea, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• EA-KAFO (Brace)

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.

Participant Groups

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 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

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]

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]

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]

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]

References

1. United States 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. [2022]

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

The effects of fixed and articulated ankle-foot orthoses on gait patterns in subjects with cerebral palsy. [2019]

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

Multidimensional Effects of Solid and Hinged Ankle-Foot Orthosis in Children With Cerebral Palsy. [2023]

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

Brace evaluation in children with diplegic cerebral palsy with a jump gait pattern. [2016]

5. England pubmed.ncbi.nlm.nih.gov

The effect of community-prescribed ankle-foot orthoses on gait parameters in children with spastic cerebral palsy. [2021]

6. France pubmed.ncbi.nlm.nih.gov

Biomechanical study of a knee-ankle-foot-orthosis for hemiplegic patients. [2017]

7. England 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. [2018]