Recruiting

Exoskeleton Use

Sponsor:

NIH

Code:

NCT06998134

Conditions

Muscle Weakness

Problems Moving Their Arms and Legs

Eligibility Criteria

Sex: All

Age: 5 - 25

Healthy Volunteers: Not accepted

Interventions

Extension assist knee ankle foot orthosis (EA-KAFO)

Study Details

Brief summary:

People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs. The NIH designed a new brace device, called an exoskeleton, that is worn on the legs and helps people walk. This study is investigating new ways the exoskeleton can be used in multiple settings while performing different walking or movement tasks, which we call ubiquitous use. For example, we will ask you to walk on a treadmill at different speeds, walk up and down a ramp, or walk through an obstacle course. Optionally, the exoskeletons may also use functional electrical stimulation (FES), a system that sends electrical pulses to the muscle to help it move the limb.

Conditions

Muscle Weakness

Problems Moving Their Arms and Legs

Study ID

NCT06998134

Start date

Jun 23, 2026

Status verified date

Jul 17, 2026

Completion date

Aug 18, 2028

Anticipated

Primary completion date

Aug 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 25

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • 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 CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • 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.

Study Design

Enrollment

23 participants

Anticipated

Interventions and Outcome Measures

Arms

Cerebral Palsy (CP)

Male and female age 5-25

Incomplete Spinal Cord Injury

Male and female age 5-25

Muscular Dystrophy

Male and female age 5-25

Spina Bifida

Male and female age 5-25

Interventions

Extension assist knee ankle foot orthosis (EA-KAFO)

A lower limb exoskeleton that has one actuated degree of freedom at the knee (flexion/extension) and a passive degree of freedom at the ankle (plantar/dorsiflexion).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jesse H Matsubara

(301) 451-7530jesse.matsubara@nih.gov

Thomas C Bulea, Ph.D.

(301) 451-7533buleatc@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institutes of Health Clinical Center (CC)

Last update posted

Jul 23, 2026

Last verified

Jul 17, 2026

Keywords

  • Cerebral Palsy (CP)
  • muscular dystrophy (MD)
  • Spina Bifida
  • incomplete spinal cord injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC) on 2026-07-23.