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
INTRODUCTION: Children with cerebral palsy (CP) classified as gross motor function classification system (GMFCS) levels III-IV demonstrate impaired sitting and reaching control abilities that hamper their overall functional performance. Yet, efficacious interventions for improving sitting-related activities are scarce. We recently designed a motor learning-based intervention delivered with a robotic Trunk-Support-Trainer (TruST-intervention), in which we apply force field technology to individualise sitting balance support. We propose a randomised controlled trial to test the efficacy of the motor intervention delivered with robotic TruST compared with a static trunk support system.
METHODS AND ANALYSIS: We will recruit 82 participants with CP, GMFCS III-IV, and aged 6-17 years. Randomisation using concealed allocation to either the TruST-support or static trunk-support intervention will be conducted using opaque-sealed envelopes prepared by someone unrelated to the study. We will apply an intention-to-treat protocol. The interventions will consist of 2 hours/sessions, 3/week, for 4 weeks. Participants will start both interventions with pelvic strapping. In the TruST-intervention, postural task progression will be implemented by a progressive increase of the force field boundaries and then by removing the pelvic straps. In the static trunk support-intervention, we will progressively lower the trunk support and remove pelvic strapping. Outcomes will be assessed at baseline, training midpoint, 1-week postintervention, and 3-month follow-up. Primary outcomes will include the modified functional reach test, a kinematic evaluation of sitting workspace, and the Box and Block test. Secondary outcomes will include The Segmental Assessment of Trunk Control test, Seated Postural & Reaching Control test, Gross Motor Function Measure-Item Set, Canadian Occupational Performance Outcome, The Participation and Environment Measure and Youth, and postural and reaching kinematics.
ETHICS AND DISSEMINATION: The study was approved by the Columbia University Institutional Review Board (AAAS7804). This study is funded by the National Institutes of Health (1R01HD101903-01) and is registered at clinicaltrials.gov.
TRIAL REGISTRATION NUMBER: NCT04897347; clinicaltrials.gov.
Santamaria, V., Ai, X., Chin, K., Dutkowsky, J., Gordon, A., & Agrawal, S. (2023). 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, 13 (8), 073166-073166. Retrieved from https://touroscholar.touro.edu/nymc_fac_pubs/4634