Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT06998134
Status
Recruiting
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Conditions

  • Muscle Weakness
  • Problems Moving Their Arms and Legs

Eligibility Criteria

Sex
ALL
Age
5 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Extension assist knee ankle foot orthosis (EA-KAFO) — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Feb 2026
Primary completion
Aug 18, 2028
Completion
Aug 18, 2028

Study Design

Enrollment
23 participants (estimated)

Arms

  • Arm: Cerebral Palsy (CP)
    Male and female age 5-25
  • Arm: Incomplete Spinal Cord Injury
    Male and female age 5-25
  • Arm: Muscular Dystrophy
    Male and female age 5-25
  • Arm: Spina Bifida
    Male and female age 5-25

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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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National Institutes of Health Clinical Center· Bethesda, MD

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