NCT04897347 Robotic TruST-Postural Intervention for Children With Cerebral Palsy
| NCT ID | NCT04897347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Teachers College, Columbia University |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-02-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2022-02-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).
Eligibility Criteria
Inclusion Criteria: * Age 6-17 years * Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia * Gross Motor Function Classification Systems-Expanded \& Review (GMFCS) levels III or IV * Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7) * Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy") Exclusion Criteria: * Absent head control (SATCo = 1) * Current medical illness unrelated to CP at the time of the study * Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements * History of recurrent seizures (daily) or drug-resistance epilepsy * Severe Spinal Deformities: scoliosis \>40◦ and/or kyphosis \>45◦ * Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months * Severe spasticity of biceps/triceps in both upper extremities (Modified Ashworth Scale = 4) * Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study * Other major surgeries in the previous 6 months (if medically contraindicated)
Contact & Investigator
Sunil Agrawal, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT04897347 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04897347 currently recruiting?
Yes, NCT04897347 is actively recruiting participants. Contact the research team at vs2578@columbia.edu for enrollment information.
Where is the NCT04897347 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT04897347 clinical trial?
NCT04897347 is sponsored by Teachers College, Columbia University. The principal investigator is Sunil Agrawal, PhD at Columbia University. The trial plans to enroll 82 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.