Back to search results

Observational Study of the EA-KAFO Exoskeleton for Muscle Weakness

This study is looking at how a special leg brace called an Extension assist knee ankle foot orthosis (EA-KAFO) works for children and young adults (ages 5-25) who have muscle weakness and difficulty moving their arms and legs. This can be due to conditions like cerebral palsy, muscular dystrophy, spina bifida, or spinal cord injury. The EA-KAFO is a device worn on the legs that helps with walking. Researchers want to see how this device can be used in many different everyday activities, like walking on a treadmill, going up a ramp, or navigating an obstacle course. They will evaluate the immediate effects of different ways the exoskeleton can help your knee move. The study plans to enroll 23 participants. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and record how the EA-KAFO works during different tasks. It is not specified if the study is randomized or blinded, and it plans to enroll 23 participants.
What's involved
You would undergo screening and calibration, then have an acclimation period to the exoskeleton. Each control mode will be tested across various daily activities, and outcomes will be compared to your abilities without the exoskeleton.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, evaluating biomechanical and neuromuscular effects, is measured at 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06998134

Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

Recruiting
Not specifiedAges 5–25Observational
National Institutes of Health Clinical Center (CC)
~23 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Extension assist knee ankle foot orthosis (EA-KAFO)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate acute biomechanical and neuromuscular effects of pediatric exoskeleton control paradigms on knee extension deficiency across ubiquitous tasks.
Measured over 4 months

Conditions

Muscle Weakness
Problems Moving Their Arms and Legs

Explore related trials

Cerebral PalsyIncomplete spinal cord injuryMuscular DystrophySpina Bifida

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Thomas C Bulea, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institutes of Health Clinical Center (CC)

Who to contact

Jesse H Matsubara
[email protected]
(301) 451-7530
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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.
Age 5 to 25 years old. Importantly, we included young adults (18-25 years old) because longterm outcomes for adults with cerebral palsy include loss of ambulatory ability. While studies of conventional gait training in this population have been conducted, use of exoskeletons in this population is very limited. Given the potential benefit of exoskeletons to reduce knee extension deficiency, it is important to determine whether novel controllers we develop are also tolerated and effective in this age group.
Either has a gait pathology arising from a diagnosis of CP, MD, SB, or iSCI or has no gait pathology.
Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension/flexion) assessed with the hip extended in a supine position. Hamstring contracture as assessed by the straight leg raising test does not limit ability to participate in the study.
Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantarflexion) with the foot in neutral alignment.
Able to walk at least 10 feet without stopping with or without a walking aid.

Exclusion

Any neurological, musculoskeletal, or cardiorespiratory injury, health condition, or diagnosis other than CP, MD, SB, or iSCI that would affect the ability to walk as directed with the robotic exoskeleton.
A history of uncontrolled seizures in the past year.
Pregnancy based on self-reporting. We excluded pregnancy due to confounding factors of pregnancy on gait.
Adult unable to consent for themselves at screening visit.

What this trial measures

  • Evaluate acute biomechanical and neuromuscular effects of pediatric exoskeleton control paradigms on knee extension deficiency across ubiquitous tasks.4 months

    To evaluate knee extension deficiency, we will use:1) Peak knee extension and2) Range of knee angle excursion (difference between maximum extension and flexion).These endpoints will be measured and compared between each control strategy within each task during the assessment visit.