Cerebral PalsyNCT06498596
Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.
An observational study of Cerebral Palsy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Age 5-25 years old male and female. Two groups. 1. Pediatric and young adult outpatients with cerebral palsy (CP) 2. Healthy volunteer the same age as CP.
Who may be able to join
- 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.
Show all 11Show fewer
- Sufficient range of motion to perform the target acquisition task, specifically:
- Knee joint range of motion of at least 50 degrees in the sagittal plane (knee extension/flexion) assessed with hip extended in supine position. Limited hamstring flexibility as assessed by straight leg raising test does not limit ability to participate in the study.
- Ankle joint range of motion of at least 40 degrees in the sagittal plane (dorsiplantar- flexion) with the foot in neutral alignment.
- Wrist joint range of motion of at least 50 degrees in the frontal plane (wrist extension/flexion) assessed with hip extended in standing position.
- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to move the required joints through the necessary range of motion or walk as directed on a treadmill.
- A history of multiple seizures that have occurred in the past year that are not controlled by medication.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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
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.
Read more
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.
Read the 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 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:
- The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee, ankle, and wrist.
- The correlation between virtual cursor dynamics and the minimum jerk trajectory during the virtual cursor target acquisition task, with and without FES.
Secondary Endpoints:
- 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
- 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
Exploratory/tertiary Endpoints:
- 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
- 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
- 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.
- To characterize the time delays between cortical activation, muscular electrical activation, muscular mechanical deformation, and resulting kinematics of the joint during volitional movement.
- 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.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Ultrasound, EEG, Exoskeleton, Functional Electrical Stimulation, Walking
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy volunteer | |
| Patient | cerebral palsy (CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effectiveness of continuous real-time dynamic ultrasound imaging for tracking joint kinematics in children and young adults with CP.
The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee, ankle, and wrist.
Measured: 3-5 visits
Secondary outcomes (1)
To use the 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 me...
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 CP2) 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
Measured: 3-5 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start20 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas C Bulea, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498596
- Sponsor's protocol ID
- 10001994
- Other IDs
- 001994-CC
- Status last verified
- 15 Jun 2026
- First submitted
- 11 Jul 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06498596
- Acronym / sponsor ID
- 10001994
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Ultrasound, EEG, Exoskeleton, Functional Electrical Stimulation, Walking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee, ankle, and wrist.
- The correlation between virtual cursor dynamics and the minimum jerk trajectory during the virtual cursor target acquisition task, with and without FES.
Secondary Endpoints:
- 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
- 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
Exploratory/tertiary Endpoints:
- 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
- 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
- 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.
- To characterize the time delays between cortical activation, muscular electrical activation, muscular mechanical deformation, and resulting kinematics of the joint during volitional movement.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy volunteer |
| Patient | – | –cerebral palsy (CP) |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Age 5-25 years old male and female. Two groups. 1. Pediatric and young adult outpatients with cerebral palsy (CP) 2. Healthy volunteer the same age as CP.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to move the required joints through the necessary range of motion or walk as directed on a treadmill.
- A history of multiple seizures that have occurred in the past year that are not controlled by medication.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the effectiveness of continuous real-time dynamic ultrasound imaging for tracking joint kinematics in children and young adults with CP.
Time frame: 3-5 visits
The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee, ankle, and wrist.
1 secondary outcome
To use the 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 me...
Time frame: 3-5 visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas C Bulea, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesse H Matsubara ((301) 451-7530, jesse.matsubara@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effectiveness of continuous real-time dynamic ultrasound imaging for tracking joint kinematics in children and young adults with CP. (time frame: 3-5 visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.