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Robotic TruST-Postural Intervention for Children With Cerebral Palsy
Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
Who can join
Ages 6 to 17 · All sexes
Full 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)
About the study
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).
What is being tested
- Robotic Trunk-Support-Trainer (TruST) (device)
- Static Trunk Support (device)
Sponsor: Teachers College, Columbia University · Participants: 82 · Started: Feb 26, 2022
Contact the study team
- Victor Santamaria, PT, PhD · Phone: 212.678.3332
- Karen Chin, MA · Phone: 212.678.3332
Official record on ClinicalTrials.gov — NCT04897347
Locations in the U.S.
| New York | Columbia University, New York Teachers College, Columbia University, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.