Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

ConditionsMuscle Weakness Problems Moving Their Arms and Legs

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age5-25

SponsorNational Institutes of Health Clinical Center (CC)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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).

Treatment groups

23 Participants

are divided into 4 treatment groups

Group A: Cerebral Palsy (CP)1 intervention

Group B: Incomplete Spinal Cord Injury1 intervention

Group C: Muscular Dystrophy1 intervention

Group D: Spina Bifida1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

4 months

Secondary outcomes

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

To ensure controllers are appropriately developed for ubiquitous use, it is vital to determine whether their intended behavior is consistent with design specifications across tasks.

Time frame

4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institutes of Health Clinical Center (CC)

Lead sponsor

Source ClinicalTrials.gov

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