Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

NCT06998134 | Recruiting

• 2 other identifiers: 10002278002278-CC
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  4 months

Secondary Outcomes (1)

• Assess whether controller behavior and performance align with the intent of its prescribed design consistently across tasks.

  4 months

Study Arms (4)

Cerebral Palsy (CP)

Male and female age 5-25

Device: Extension assist knee ankle foot orthosis (EA-KAFO)

Incomplete Spinal Cord Injury

Male and female age 5-25

Device: Extension assist knee ankle foot orthosis (EA-KAFO)

Muscular Dystrophy

Male and female age 5-25

Device: Extension assist knee ankle foot orthosis (EA-KAFO)

Spina Bifida

Male and female age 5-25

Device: Extension assist knee ankle foot orthosis (EA-KAFO)

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).

Cerebral Palsy (CP); Incomplete Spinal Cord Injury; Muscular Dystrophy; Spina Bifida

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient age 5-25 cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (5)

• Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the "common" neurologic disorders? Neurology. 2007 Jan 30;68(5):326-37. doi: 10.1212/01.wnl.0000252807.38124.a3.

  PMID: 17261678 BACKGROUND

• Emery AE. The muscular dystrophies. Lancet. 2002 Feb 23;359(9307):687-95. doi: 10.1016/S0140-6736(02)07815-7.

  PMID: 11879882 BACKGROUND

• Mitchell LE, Adzick NS, Melchionne J, Pasquariello PS, Sutton LN, Whitehead AS. Spina bifida. Lancet. 2004 Nov 20-26;364(9448):1885-95. doi: 10.1016/S0140-6736(04)17445-X.

  PMID: 15555669 BACKGROUND

• McDonald JW, Sadowsky C. Spinal-cord injury. Lancet. 2002 Feb 2;359(9304):417-25. doi: 10.1016/S0140-6736(02)07603-1.

  PMID: 11844532 BACKGROUND

• Damiano DL, Abel MF. Relation of gait analysis to gross motor function in cerebral palsy. Dev Med Child Neurol. 1996 May;38(5):389-96. doi: 10.1111/j.1469-8749.1996.tb15097.x.

  PMID: 8698147 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Muscle Weakness; Cerebral Palsy; Muscular Dystrophies; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Disorders, Atrophic; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities

Study Officials

• Thomas C Bulea, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse H Matsubara

CONTACT

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

Thomas C Bulea, Ph.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: May 31, 2025
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): August 18, 2028
• Study Completion (Estimated): August 18, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-02-27

Locations

US (1)