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New treatment option for Cerebral Palsy
Official title Robotic TruST-Postural Intervention for Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT04897347
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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")
You likely can't join if
- 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
See the full eligibility 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")
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.