Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Teachers College, Columbia University

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Device: Robotic Trunk-Support-Trainer (TruST); Device: Static Trunk Support

Study type: Interventional

Funder types: Other

Identifiers

NCT04897347

AAAS7804

1R01HD101903-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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 based on motor learning and control principles. In both groups, participants will engage in play and functional activities that elicit arm movement and challenge trunk postural control, and the motor tasks and activities will be progressed. The main difference is that the experimental group will be trained with TruST in order to add postural task-progression via assistive force fields; which will be tailored to the child's sitting control balance status across training sessions. However, in the control group, postural task-progression will be addressed by lowering the level of rigid trunk support segment by segment across training sessions. The trunk subregion where the support is placed will depend on the child's trunk control ability. Participants will be recruited from the United States.

Enrollment: 82 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Robotic Trunk-Support-Trainer (TruST)

Experimental group

Description:

Postural-reaching control intervention with TruST

Treatment:

Device: Robotic Trunk-Support-Trainer (TruST)

Static Trunk Support

Active Comparator group

Description:

Postural-reaching control intervention with Rigid Trunk Support

Treatment:

Device: Static Trunk Support