Robotic training to improve neck control in children and young adults with cerebral palsy.
Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace
NA · Columbia University · NCT06533293
This project will try a gentle robotic system to see if it helps young people (ages 11–21) with bilateral cerebral palsy and GMFCS IV–V improve head and neck coordination.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 11 Years to 21 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06533293 on ClinicalTrials.gov |
What this trial studies
The study first records head-neck motion and muscle activity in a single session using motion capture, body-mounted sensors, and EMG to characterize kinematics across children with bilateral cerebral palsy (GMFCS IV–V) and able-bodied controls. In a second phase, a prospective quasi-experimental cohort of participants will receive 12 robotic-assisted training sessions with measurements at baseline, during training, one week after training, and at three months. Functional outcomes include the Seated Posture and Reaching Control (SP&R-co) test as the primary outcome, with GMFM and COPM as secondary measures. The study plans to recruit about 30 participants aged 11–21, including 20 with CP (10 GMFCS IV, 10 GMFCS V) and 10 able-bodied controls for the characterization phase.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 11–21 with bilateral cerebral palsy classified GMFCS IV or V who can tolerate testing and training and do not have the listed exclusions.
Not a fit: Patients with severe cognitive impairment, uncontrolled epilepsy, severe dyskinesia, major spinal malformations or extreme vertebral deformities, blindness, recent chemo-denervation, or those outside the age range are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the robotic training could improve head-neck coordination and seated posture, which may enhance reaching ability, daily function, and caregiver support needs.
How similar studies have performed: Robotic motor-training has shown promise for limb and trunk control in cerebral palsy, but using robotics specifically to train head-neck coordination is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CP, as medical diagnosis * GMFCS IV-V classification Exclusion Criteria: * 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
Where this trial is running
New York, New York and 1 other locations
- ROAR Lab, Mudd Hall — New York, New York, United States (RECRUITING)
- Columbia University Irving Medical Center — New York, New York, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Sunil Agrawal — Columbia University
- Study coordinator: Sunil K Agrawal, PhD
- Email: sunil.agrawal@columbia.edu
- Phone: 2128542841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Neck Disorder, Motor training, Robotics