An interventional study of EA-KAFO in Cerebral Palsy, Muscular Dystrophy and Spina Bifida, sponsored by National Institutes of Health Clinical Center (CC). Recruiting at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Device feasibility
Background:
People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.
Objective:
To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.
Eligibility:
People aged 3 to 17 years with a gait disorder involving the knee joint.
Design:
Participants will be screened. They will have a physical exam. Their walking ability will be tested.
Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.
The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.
During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.
During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.
Participants walking ability will be retested after each phase....
Study Description:
This randomized crossover trial will determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting has a beneficial effect on walking ability, muscle activity, and overall gross motor function. Participants will be randomized into two groups, one that receives the exoskeleton therapy first before crossing over to continue standard therapy and one that continues standard therapy before completing the exoskeleton intervention. An in-lab training and accommodation period will be completed prior to the exoskeleton being sent home for use outside the clinical setting. We will monitor exoskeleton use during the intervention period for compliance and safety. Assessments of gait biomechanics, neuromuscular activity and functional mobility will be completed before and after the intervention and at 6 weeks post- intervention. It is hypothesized that the 12-week exoskeleton intervention outside the clinic setting will show greater improvements than the standard therapy.
Objectives:
Primary Objective: To evaluate the effectiveness of a longitudinal robotic exoskeleton gait training paradigm in improving crouch gait from CP or knee extension deficiency from SB, iSCI or MD in children, assessed as improvement in knee angle during walking before and after the intervention period.
Secondary Objectives:
To evaluate changes in muscle strength and gait speed following longitudinal intervention with robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to evaluate the primary endpoint of knee joint range of motion at multiple time points to assess for order effect and persistence of any observed effect.
Exploratory Objectives:
To assess the effect of exoskeleton dosage (i.e., time spent using the device) on the primary endpoint.
Additionally, to evaluate change in knee extensor and flexor muscle spasticity following longitudinal intervention with a robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to asses improvement in gross motor function following the same intervention. Finally, to evaluate the safety and feasibility of a community-based protocol for rehabilitation using a pediatric robotic exoskeleton.
Endpoints:
Primary Endpoint: Knee extension as assessed by peak knee angle during midstance phase of walking.
Secondary Endpoints: Change in knee extensor muscle activation and strength after exoskeleton intervention; Change in average gait speed after exoskeleton intervention; Persistence of the primary endpoint (change in knee angle) at 6 weeks post intervention; Effect of order of standard therapy and exoskeleton intervention.
Exploratory Endpoints:
Effect of exoskeleton intervention dosage on change in peak knee angle during walking; Change in knee extensor and flexor spasticity after exoskeleton intervention; Improvement in gross motor function after exoskeleton intervention; Feasibility and safety of exoskeleton use outside clinical setting assessed by participant compliance and occurrence of adverse events, respectively.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 44 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 weeks-study intervention
Device: EA-KAFO
12 weeks the control first.
This study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee.
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.
The primary endpoint will be knee extension range of motion. This will be assessed using knee angle at two positions in the gait cycle: knee angle at initial contact and peak knee angle during stance
Time frame: 36 Weeks
To evaluate improvement in overground walking of children with CP, SB, iSCI or MD as a function of average gait speed while walking with the robotic exoskeleton
This outcome will be measured using peak and mean activation of knee extensor and knee flexor muscles during walking.
Time frame: 15 Weeks
Plan to share: Undecided — Undecided: It is not yet known if there will be a plan to make IPD available
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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