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Background:
Cerebral palsy (CP) is the most common motor disorder that affects children. People with CP have weak muscles; they may have trouble controlling the movements of their arms and legs. Researchers have been developing braces called robotic exoskeletons for people with CP. These devices can adapt to the person s movements and help them move better. This natural history study will explore new technologies that may tell us more about how people with CP move and improve how these exoskeletons work.
Objective:
To test new technologies to measure people s movements and brain function while they move with and without a robotic exoskeleton.
Eligibility:
People aged 5 to 25 years with CP. Healthy volunteers are also needed.
Design:
Participants will have 3 to 5 clinic visits in 2 months.
Participants will be fitted with an exoskeleton that will be worn on one of their legs.
At each visit, participants will be asked to move their wrist, ankle, and knee while the following measurements are taken:
Ultrasound. A bar will be placed against the skin. It will send soundwaves into the body to take pictures of the muscles.
Electroencephalography (EEG). Participants will wear a cap with sensors. Their brain waves will be recorded.
Electromyography (EMG). Small metal discs will be taped to the skin. They will measure electrical activity of muscle.
Participants will flex and extend each joint (wrist, ankle, or knee) on one side of their body. These movements will be done on their own and while assisted by two devices:
Functional electrical stimulation (FES). Small adhesive pads will be placed on the skin and electric. Pulses will stimulate muscles to help move the limb. This will be done for the wrist, ankle and knee.
Robotic Exoskeleton. A leg brace will be placed on one limb with a motor that will help move the knee. The exoskeleton can be used with or without FES.
Participants will also walk on a treadmill at their own pace.
Photographs and videos will record how they move.
Full description
Study Description:
This protocol will explore the use of multimodal signal acquisition techniques such as surface electromyography (sEMG), electroencephalography (EEG), dynamic ultrasound imaging (US), and motion capture for characterizing and modulating movement in children and young adults with cerebral palsy (CP). The protocol is divided into two parts. In Part I, participants will perform single degree of freedom movement tasks using three joints (ankle plantar flexion-dorsiflexion, knee flexion-extension, and wrist flexion/extension) with or without FES assistance, as well as walking on a treadmill. Real-time ultrasound imaging will be used to monitor their muscle movement during these tasks and they will perform a target achievement task based on this measured muscle movement. The hypothesis is that the ultrasound imaging technique will enable us to extract movement intent in real-time from the participants, and hence characterize (and correlate) their movement in multiple signal domains - brain activity, electrical muscle activity, muscle deformations, as well as resulting kinematics. In Part II, they will perform a knee flexion-extension task with or without FES assistance and with or without robotic exoskeleton assistance. The exploratory aim of this part is to investigate the feasibility of using real-time ultrasound imaging for control of a robotic exoskeleton and FES.
Objectives:
Primary Objectives: The primary objectives of this study are (1) to investigate the effectiveness of continuous real-time dynamic ultrasound imaging for tracking joint kinematics and (2) to evaluate its initial feasibility as a control signal for wearable exoskeletons and functional electrical stimulation through control of a virtual cursor in children and young adults with CP.
Secondary Objective: The secondary objective is to use this same multimodal data to characterize the temporal and magnitude relationships between movement initiation in the cortex measured by EEG, muscle electrical activation measured by sEMG, muscle deformation measured by US, and limb movement measured by motion capture, in children and young adults with CP and healthy controls.
Endpoints:
Primary Endpoints:
Secondary Endpoints:
Exploratory/tertiary Endpoints:
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Inclusion and exclusion criteria
In order to be eligible to participate in this study, an individual must meet criteria 1-4 and 5a as given below. If they also meet 5b, 5c or 6, they will perform the tasks related to the respective joint(s) for which criteria are met, and/or walking.:
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.
Group A: Have a gait pathology arising from a diagnosis of cerebral palsy.
Group B: Healthy volunteers who are age and sex matched to individuals recruited in Group A.
Sufficient range of motion to perform the target acquisition task, specifically:
Able to walk at least 1 minute on a treadmill without stopping with or without holding onto side or front support rails. This assessment will be completed by the physician during the medical history and physical exam.
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
30 participants in 2 patient groups
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Central trial contact
Thomas C Bulea, Ph.D.; Jeffrey A Fairman
Data sourced from clinicaltrials.gov
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