Robotic intervention for improving posture and reaching in children with cerebral palsy
Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
This study is testing a robotic device to see if it can help children with cerebral palsy improve their posture and reaching skills better than regular support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Teachers College, Columbia University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04897347 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a robotic device called the Trunk-Support-Trainer (TruST) in enhancing postural and reaching control in children with cerebral palsy. It involves a randomized control trial with 82 participants aged 6 to 17 years, comparing the TruST intervention to traditional static trunk support. Both groups will engage in play and functional activities designed to improve motor skills, but the TruST group will receive tailored assistance to progress their postural tasks. The study focuses on children classified as GMFCS levels III and IV, who have specific trunk control abilities.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-17 years with bilateral cerebral palsy classified as GMFCS levels III or IV.
Not a fit: Patients with absent head control, severe dyskinesia, or significant spinal deformities may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve motor control and functional abilities in children with cerebral palsy.
How similar studies have performed: Other studies have shown promise in using robotic devices for motor learning in children with cerebral palsy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York and 1 other locations
- Columbia University — New York, New York, United States (Recruiting)
- Teachers College, Columbia University — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sunil Agrawal, PhD — Columbia University
- Study coordinator: Victor Santamaria, PT, PhD
- Email: vs2578@columbia.edu
- Phone: 212.678.3332
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.