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

Overview

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.

Interventions

• Device Robotic 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)
• Device Static 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)

Primary outcome measures

• Change in Modified Functional Reach Test (mFRT) after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Postural Star-Sitting Test (PSST) after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Box and Blocks Test (BBT) after intervention [Time frame: Through study completion, an average of 4 months]

Secondary outcome measures (6)

• Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Canadian Occupational Performance Measure (COPM) after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Seated Postural & Reaching Control (SP&R-co) after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Postural and Reaching Kinematics after intervention [Time frame: Through study completion, an average of 4 months]
• Change in Segmental Assessment of Trunk Control (SATCo) after intervention [Time frame: Through study completion, an average of 4 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Columbia University — New York
• Teachers College, Columbia University — New York

Publications

• Santamaria V, Ai X, Chin K, Dutkowsky JP, Gordon AM, Agrawal SK. Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems. BMJ Open. 2023 Aug 17;13(8):e073166. doi: 10.1136/bmjopen-2023-073166. PMID 37591642

Identifiers

NCT: NCT04897347 · AAAS7804 · 1R01HD101903-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗