Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural...

Area of Science:

• Rehabilitation Engineering
• Motor Learning
• Pediatric Physical Therapy

Background:

• Children with cerebral palsy (CP) classified under Gross Motor Function Classification System (GMFCS) levels III-IV often experience significant challenges with sitting and reaching control, impacting their functional performance.
• Existing interventions for improving sitting-related activities in this population are limited.
• A novel motor learning-based intervention utilizing a robotic Trunk-Support-Trainer (TruST) with individualized force field technology for sitting balance support has been developed.

Purpose of the Study:

• To evaluate the efficacy of a motor learning-based intervention delivered via a robotic TruST compared to a static trunk support system.
• To assess the impact of the TruST intervention on sitting balance, reaching control, and overall functional performance in children with CP (GMFCS III-IV).

Main Methods:

• A randomized controlled trial involving 82 participants with CP (GMFCS III-IV), aged 6-17 years.
• Interventions included 2 hours/session, 3 times/week for 4 weeks, with progressive task difficulty and support reduction.
• Outcomes measured at baseline, midpoint, post-intervention, and 3-month follow-up, including modified functional reach test, kinematic sitting workspace, Box and Block test, and various functional/participation measures.

Main Results:

• Primary outcomes included modified functional reach test, kinematic sitting workspace evaluation, and the Box and Block test.
• Secondary outcomes encompassed The Segmental Assessment of Trunk Control, 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.
• Data collection occurred at baseline, training midpoint, 1-week post-intervention, and 3-month follow-up.

Conclusions:

• The study aims to determine if the robotic TruST intervention offers superior benefits compared to traditional static support for children with CP.
• Findings will inform the development of more effective rehabilitation strategies for improving functional abilities in children with severe motor impairments.
• This research contributes to the field of assistive technology and motor rehabilitation for pediatric populations.