At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders
In Brief
A clinical study evaluating EA-KAFO for Incomplete Spinal Cord Injury and 3 related conditions. Completed, enrolled 24 participants across 1 site.
Signals
Detailed Summary
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: * Children 5 17 years old with CP. * Healthy volunteers 5 17 years old. Design: * All participants will be screened with medical history and physical exam. * Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below. * Participants with CP will have 6 visits. * Visit 1: \<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. * Visit 2: * Participants will wear their new braces and have them adjusted. * Steps 1 3 will be repeated. * EEG: Small metal discs will be placed on the participants scalp. They record brain waves. * Participants will have electrical stimulation of their knees and practice extending them. * Participants will take several walks with the braces in different settings. * Visits 3 5: participants will repeat the walking and some other steps from visit 2. * Visit 6 will repeat visit 2.
Study Details
Timeline
Arms & Interventions
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.
Interventions
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.