Status:
RECRUITING
Robotic TruST-Postural Intervention for Children With Cerebral Palsy
Lead Sponsor:
Teachers College, Columbia University
Collaborating Sponsors:
Columbia University
Conditions:
Cerebral Palsy
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
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 mot...
Detailed Description
This study is a prospective Clinical Randomized Control Trial (RCT) in a group of 82 children with cerebral palsy. The experimental and control groups will receive effective postural-reaching training...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04897347
Start Date
February 26 2022
End Date
June 1 2027
Last Update
December 22 2023
Active Locations (2)
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1
Columbia University
New York, New York, United States, 10027
2
Teachers College, Columbia University
New York, New York, United States, 10027