An interventional study of EA-KAFO in Incomplete Spinal Cord Injury, Muscular Dystrophy and Spina Bifida, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 5 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Device feasibility
Background:
- Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group.
Objective:
- To evaluate a new brace to improve crouch gait in children with CP.
Eligibility:
Design:
\<TAB>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement.
\<TAB>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity.
\<TAB>3. Participants knee movement will be tested.
\<TAB>4. Participants will walk 50 meters.
\<TAB>5. Participants legs will be cast to make custom braces.
Objective
The purpose of this protocol is to evaluate several configurations of a prototype Extension Assist Knee-Ankle-Foot Orthosis (EA-KAFO) in patients with cerebral palsy (CP), muscular dystrophy (MD), spina bifida (SB), or incomplete spinal cord injury (iSCI) who have knee extension deficiency. Three forms of assistance will be provided at the knee joint including a passive-damper component, functional electrical stimulation (FES) to the quadriceps, and a motorized assist. One form will provide controllable resistance at the knee to strengthen muscles and promote knee extension after the resistance is removed. These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints. We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions. We further hypothesize that a best solution for each participant will exist, but may vary across subjects due to the heterogeneity of these movement disorders. Preliminary data on brain activation using EEG will be collected during all walking conditions.
Study population
Thirty (30) subjects, age 5 and above, diagnosed with crouch gait from diplegic CP, (30) subjects, age 5 and above, with knee extension deficiency from MD, SB, or iSCI (15 from each group) and 10 age-matched healthy volunteers will be recruited.
Design
This protocol will evaluate an EA-KAFO prototype consisting of a custom fabricated brace combined with a modular knee joint with three modes of operation: hinge (no assist), a passive spring-damper, and an active motorized assist. Since crouch can also be precipitated at the ankle, the orthotic ankle joint has an adjustable dynamic resistance (ADR) mechanism that can be locked (passive assist) to simulate a standard brace, free, or provide variable resistance to assist knee extension. Additionally, we will combine quadriceps FES with the hinge and the passive damper to create two hybrid configurations. The hinge and the passive damper (Ultraflex ) knee modules, and ADR ankle brace are FDA-approved (Class I), commercially available devices. This protocol for evaluation of the active motorized joint module, the two hybrid configurations, and the controllable resistance device (PowerWalk by Agilik Technologies) has been reviewed by the FDA as a medical device study and was determined by the FDA to be non-significant risk. Healthy controls will come for one visit, and participants with movement disorders will complete 6-10 visits: 1) initial assessment and casting for custom leg brace; 2) EA-KAFO configuration; 3) initial data collection and practice; 4-5) accommodation to brace configurations; 6) final data collection. Additional accommodation visits may be added if necessary, up to the maximum of 10 total visits. Participants with movement disorders will be permitted to re-enroll in the protocol is a minimum of 1 year has passed from their prior final visit. Motion capture, force plates, and electromyography (EMG) will be used for gait analysis while electroencephalography (EEG) will measure brain activity during walking.
Outcome measures
The primary outcome is the amount of knee flexion during gait. The optimal solution for each individual will be that which provides the greatest reduction in peak knee angle. Secondary outcomes will include gait speed, knee extensor moment, and EEG activation profiles.
224 studies on the registry are indexed under Muscular Dystrophies; 48 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 140 interventional studies indexed under Muscular Dystrophies.
Browse Muscular Dystrophies 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.
Counted across the registry records on this site, refreshed daily.
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.
EXCLUSION CRITERIA:
ADDITIONAL EXCLUSION CRITERIA FOR INDIVIDUALS WITH CEREBRAL PALSY:
All participants will be evaluated using the different configurations of the EA-KAFO (see Table 1 in the protocol), which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton. Each subject will serve as their own control to assess the effect of each configuration of the EA-KAFO interventions.
Device: EA-KAFO
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.
Peak knee angle
The primary outcome measure will be the effect of the intervention on crouch, as measured by peak knee angle during walking with the EA-KAFO. the outcome description refers to the general Extension Assist Knee Ankle Foot Orthosis (EA-KAFO). The outcome measure will be assessed across the different configurations of the EA-KAFO, which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton.
Time frame: This outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.
Secondary outcome measures
Secondary outcome measures, assessed at the same time frame and across the same configurations of the EA-KAFO as the primary outcome measure, include Gait Speed and Knee Joint Moment.
Time frame: At the same time
Plan to share: Undecided — Protocol is silent about sharing IPD.
Ran from Jul 2015 to primary completion in Jun 2025, 119 months.
Of 46 non-industry interventional studies with no phase under Muscular Dystrophies, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's 119 months is above that.
Counting every sponsor, half of 48 studies reached it within 33 months; a quarter within 11 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institutes of Health Clinical Center (CC) →