What this study is
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's being tested
- Robotic Trunk-Support-Trainer (TruST)
Intervention · DEVICE
This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training. - Twelve 2hr training sessions (3 times per week for 4 weeks)
- Static Trunk Support
Intervention · DEVICE
This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training. - Twelve 2hr training sessions (3 times per week for 4 weeks)
Study details
- Official title
- Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
- Sponsor
- Teachers College, Columbia University
- Conditions
- Cerebral Palsy
- Enrolling
- 82 people
- Starts
- 2022-02-26
- Est. completion
- 2027-06
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify 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 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
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openColumbia University
New York, New York, United States
- Victor Santamaria, PT, PhD · Contact212-678-3332vs2578@columbia.edu
RecruitingTeachers College, Columbia University
New York, New York, United States
- Karen Chin, MA · Contact212-678-3332cpresearch@tc.columbia.edu
Recruiting
Study team
Sponsor
Teachers College, Columbia University
Study ID AAAS7804
Principal investigator
Sunil Agrawal, PhD
Columbia University
Principal investigator
Andrew Gordon, PhD
Teachers College, Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.