Clinical trial NCT04897347: Robotic TruST-Postural Intervention for Children With Cerebral Palsy
Official title: Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Posture
Reaching
Robotics
Motor Learning
Motor Control
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2021-05-21
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Modified Functional Reach Test (mFRT) after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Postural Star-Sitting Test (PSST) after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Box and Blocks Test (BBT) after intervention
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Canadian Occupational Performance Measure (COPM) after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Seated Postural & Reaching Control (SP&R-co) after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Postural and Reaching Kinematics after intervention
timeFrame: Through study completion, an average of 4 months
measure: Change in Segmental Assessment of Trunk Control (SATCo) after intervention
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Sunil Agrawal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Teachers College, Columbia University
name: Andrew Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: