Cerebral PalsyNCT06533293
Improving Neck Control in Children With Cerebral Palsy Using Robotics
A study testing Neck Brace Device in people with Cerebral Palsy and Neck Disorder, run by Columbia University at 2 sites in United States.
Trial summary
The goal of this study is to characterize the head-neck motion of children with cerebral palsy and investigate how robotics can be used to improve the head-neck coordination of these children. Aim 1 is a cross-sectional study. Read more about this study
- Who is it for?
- Ages 11 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Neck Disorder
- What is being tested?
- Neck Brace Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2025to 30 Dec 2026
- Phase
- Interventional
- 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 11 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- CP, as medical diagnosis
- GMFCS IV-V classification
Who cannot join
- severe cognitive deficits
- uncontrolled epilepsy
- severe dyskinesia
- spinal cord malformations
- severe vertebral column deformities (scoliosis >40° and/or kyphosis >45º)
- blindness
- chemo-denervation 3 months before study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Victor Santamaria contact
United States2 sites, 2 recruiting
- Recruiting
ROAR Lab, Mudd Hall
New York, New York, 10027
Sunil Agrawal, PhD, 212-854-2841, sunil.agrawal@columbia.edu
- Not yet recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Sunil Agrawal, 212-854-2841, sunil.agrawal@columbia.edu
About this study
Official title: Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace
The goal of this study is to characterize the head-neck motion of children with cerebral palsy and investigate how robotics can be used to improve the head-neck coordination of these children.
Aim 1 is a cross-sectional study. In this single-session, kinematic and muscle activity data will be collected during the postural static, active-proactive, and reactive postural head tasks. Gross Motor Functional Classification System (GMFCS) levels will also be collected to categorize the sample into subgroups.
Read more
Aim 2 is a prospective cohort quasi-experimental study. The data will be collected at baseline, across 12 intervention sessions, 1 week post-intervention, and 3 months follow-up.
Functional assessments will be used to compare across the pre, mid, and post training. Participants will be assessed in Gross Motor Functional Measures (GMFM), Seated Posture and Reaching Control (SP\&R-co), and Canadian Occupational and Performance Measure (COPM). The primary outcomes will be SP\&R-co test and COPM pre- and post-intervention.
Read the detailed description
The study investigators plan to recruit a sample of 30 children and adults (10 able-bodied children/young adults for the characterization phase and 20 children/young adults with bilateral cerebral palsy: 10 classified as GMFCS IV and 10 classified as GMFCS V). These participants will be aged 11-21 years.
A motion capture/body mounted sensors and Electromyography (EMG) system will be used for measurement. This study will utilize specialized robotics that can apply gentle forces on the head-neck during movement training using the principles of motor learning.
- Conditions
- Cerebral Palsy, Neck Disorder
- Being tested
- Neck Brace Device
- Keywords
- Motor training, Robotics
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck Brace DeviceDevice
The neck brace device will be manufactured in the Mechanical Department at Columbia University. The device measures head motion and EMG by electronic sensors, passively supports the head in certain configurations by springs, and actively assists head movement by motors.
Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training. Receives: Device: Neck Brace Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Postural and Reaching Control (SP&R-co)
Measurement of head-trunk and reaching control of children and young adults with CP while sitting static, active, proactive, and reactive postural dimensions while providing support at different regions of the torso.
Measured: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
Secondary outcomes (2)
Gross Motor Functional Measure-items set (GMFM-IS)
This is an abbreviated version of the original GMFM-66 to measure the gross motor status of the children with CP across 5 dimensions: A) lying and rolling, B) Sitting, C) Crawling and Kneeling, D) Standing and E) Walking, Running and Jumping.
Measured: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
Canadian Occupational Performance Outcome (COPM)
Measurement of perceived parent- and child-based goals and preferences that are specific to motor impediments that restrict participation.
Measured: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start6 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (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.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Medical College
- Responsible party
- Principal investigator, Sunil Agrawal, Columbia University
- Investigators
- Sunil Agrawal, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533293
- Sponsor's protocol ID
- AAAV1209
- Status last verified
- Sep 2025
- First submitted
- 8 Jun 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a exploratory study at this point.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace
- ClinicalTrials.gov ID
- NCT06533293
- Acronym / sponsor ID
- AAAV1209
- Conditions
- Cerebral Palsy, Neck Disorder
- Keywords
- Motor training, Robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York Medical College
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Aug 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.
The goal of this study is to characterize the head-neck motion of children with cerebral palsy and investigate how robotics can be used to improve the head-neck coordination of these children.
Aim 1 is a cross-sectional study. In this single-session, kinematic and muscle activity data will be collected during the postural static, active-proactive, and reactive postural head tasks. Gross Motor Functional Classification System (GMFCS) levels will also be collected to categorize the sample into subgroups.
Aim 2 is a prospective cohort quasi-experimental study. The data will be collected at baseline, across 12 intervention sessions, 1 week post-intervention, and 3 months follow-up.
Functional assessments will be used to compare across the pre, mid, and post training. Participants will be assessed in Gross Motor Functional Measures (GMFM), Seated Posture and Reaching Control (SP\&R-co), and Canadian Occupational and Performance Measure (COPM). The primary outcomes will be SP\&R-co test and COPM pre- and post-intervention.
Detailed description
The study investigators plan to recruit a sample of 30 children and adults (10 able-bodied children/young adults for the characterization phase and 20 children/young adults with bilateral cerebral palsy: 10 classified as GMFCS IV and 10 classified as GMFCS V). These participants will be aged 11-21 years.
A motion capture/body mounted sensors and Electromyography (EMG) system will be used for measurement. This study will utilize specialized robotics that can apply gentle forces on the head-neck during movement training using the principles of motor learning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Neck Brace DeviceMotor learning principles will be combined with robotics to apply gentle forces on the head-neck during training. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- CP, as medical diagnosis
- GMFCS IV-V classification
Key exclusion criteria (7 listed)
- severe cognitive deficits
- uncontrolled epilepsy
- severe dyskinesia
- spinal cord malformations
- severe vertebral column deformities (scoliosis >40° and/or kyphosis >45º)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck Brace DeviceThe neck brace device will be manufactured in the Mechanical Department at Columbia University. The device measures head motion and EMG by electronic sensors, passively supports the head in certain configurations by springs, and actively assists head movement by motors. Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training. | Device | Device |
Primary outcome
Seated Postural and Reaching Control (SP&R-co)
Time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
Measurement of head-trunk and reaching control of children and young adults with CP while sitting static, active, proactive, and reactive postural dimensions while providing support at different regions of the torso.
2 secondary outcomes
Gross Motor Functional Measure-items set (GMFM-IS)
Time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
Canadian Occupational Performance Outcome (COPM)
Time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
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 9 Sep 2025.
- Amyotrophic lateral sclerosis patients regain head-neck control using a powered neck exoskeletonLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a exploratory study at this point.
Related trials for Cerebral Palsy
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Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
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Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruitingObservational study
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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.
Victor Santamaria contact
Sunil Agrawal principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck Brace Device in people with Cerebral Palsy and Neck Disorder, run by Columbia University at 2 sites 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 2 inclusion and 7 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sunil K Agrawal, PhD (2128542841, sunil.agrawal@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seated Postural and Reaching Control (SP&R-co) (time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.). 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 9 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.