Robotic intervention for improving posture and reaching in children with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.