Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
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
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 design
Treatments tested in this trial
- Extension assist knee ankle foot orthosis (EA-KAFO)
Treatment groups
23 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov