RecruitingNot ApplicableNCT04897347

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial

Sponsor

Teachers College, Columbia University

Enrollment

82 participants

Start Date

Feb 26, 2022

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy

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 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).

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Inclusion Criteria5

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 Criteria9

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)

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Interventions

DEVICERobotic Trunk-Support-Trainer (TruST)

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)

DEVICEStatic Trunk Support

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)