Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498596
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-11
Brief Title:
Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Natural History Study Evaluating the Use of Multimodal Signal Acquisition Techniques to Characterize Movement in Children and Young Adults With Movement Disorders
Status:
RECRUITING
Status Verified Date:
2024-07-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 3 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
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 3 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
Detailed 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 flexionextension 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
1 The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee ankle and wrist
2 The correlation between virtual cursor dynamics and the minimum jerk trajectory during the virtual cursor target acquisition task with and without FES
Secondary Endpoints
1 To evaluate the relationship between the dynamics of sEMG activation and ultrasound-derived joint kinematics during a single degree of freedom movement task of the knee ankle and wrist - with and without FES - in children and young adults with CP
2 To evaluate the correlation between kinematics derived from US imaging of muscles as well as sEMG and the measured joint kinematics during treadmill walking in children and young adults with CP
Exploratorytertiary Endpoints
1 To evaluate the feasibility of using continuous real-time dynamic ultrasound imaging for control of a single degree of freedom task while wearing a robotic exoskeleton in children and young adults with CP
2 To evaluate the feasibility of using real-time continuous ultrasound imaging to guide closed loop control of functional electrical stimulation parameters during a single degree of freedom movement task
3 To evaluate the feasibility of using real-time continuous ultrasound imaging to guide the stimulation properties during FES and cause intended movement while a robotic exoskeleton is used to provide resistance against such movement
4 To characterize the time delays between cortical activation muscular electrical activation muscular mechanical deformation and resulting kinematics of the joint during volitional movement
5 To characterize the electrical muscular activation profiles and mechanical muscle deformation profiles in children and young adults with CP during a full range of motion single degree of freedom task
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 flexionextension 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
1 The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee ankle and wrist
2 The correlation between virtual cursor dynamics and the minimum jerk trajectory during the virtual cursor target acquisition task with and without FES
Secondary Endpoints
1 To evaluate the relationship between the dynamics of sEMG activation and ultrasound-derived joint kinematics during a single degree of freedom movement task of the knee ankle and wrist - with and without FES - in children and young adults with CP
2 To evaluate the correlation between kinematics derived from US imaging of muscles as well as sEMG and the measured joint kinematics during treadmill walking in children and young adults with CP
Exploratorytertiary Endpoints
1 To evaluate the feasibility of using continuous real-time dynamic ultrasound imaging for control of a single degree of freedom task while wearing a robotic exoskeleton in children and young adults with CP
2 To evaluate the feasibility of using real-time continuous ultrasound imaging to guide closed loop control of functional electrical stimulation parameters during a single degree of freedom movement task
3 To evaluate the feasibility of using real-time continuous ultrasound imaging to guide the stimulation properties during FES and cause intended movement while a robotic exoskeleton is used to provide resistance against such movement
4 To characterize the time delays between cortical activation muscular electrical activation muscular mechanical deformation and resulting kinematics of the joint during volitional movement
5 To characterize the electrical muscular activation profiles and mechanical muscle deformation profiles in children and young adults with CP during a full range of motion single degree of freedom task
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001994-CC | None | None | None |