Non-ambulatory children with cerebral palsy (CP) and similar childhood-onset neuromotor conditions face many challenges to fulsome participation in everyday life. Recent initial phase research suggests that physiotherapy paired with use of robotic exoskeletons, such as the Trexo exoskeleton ("The Trexo"; Trexo Robotics, Canada) provides a novel opportunity for children with severe mobility challenges to experience active walking that is individualized to their movement potential (guiding and powering leg movements) and upright support needs. This before-and-after study will assess the first-time experience of 10 non-ambulatory children (ages 4-7) using the Trexo for 6 weeks of twice weekly physiotherapy sessions, and evaluate associated brain, muscle and functional outcomes including accomplishment of individualized goals. To study clinical utility, we will simultaneously capture physiotherapists' (PTs) and PT assistants' (PTAs) training/learning/user experiences with the Trexo's first time use within our center's out-patient program and on-site affiliated school. This project will contribute evidence-based knowledge to guide clinical decisions about introduction of the Trexo within pediatric rehabilitation settings (target demographic, potential goals, integration into physiotherapy) and be a foundation for a progressive program of multi-centre research. Overall, we hope that this research will lead to better opportunities for children's meaningful participation within the community, including family and peers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Wearable pediatric robotic walker for the lower extremities
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
Gross Motor Function Measure (GMFM)-88 - changes from Baseline
Standard for measuring gross motor skills in children with CP and related neuromotor disorders
Time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention
Mechanomyography (MMG) - changes from Baseline
Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)
Time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention
Structural Magnetic resonance Imaging (MRI) - changes from Baseline
T1 anatomical scan - grey and white matter volumes
Time frame: Baseline, following 6 weeks of intervention, 1 month post-intervention
Diffusion Magnetic resonance imaging (MRI) - changes from Baseline
Multi shell diffusion imaging - kurtosis fractional anisotropy measures
Time frame: Baseline, following 6 weeks of intervention, 1 month post-intervention
Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline
Whole-brain analysis based on BOLD signal changes
Time frame: Baseline, following 6 weeks of intervention, 1 month post-intervention
Canadian Occupational Performance Measure (COPM) - changes from Baseline
Parent reported qualitative questionnaire for gait related goals
Time frame: Weekly check-ins for 6 weeks
Goal Attainment Scaling (GAS) - changes from Baseline
Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2
Time frame: Weekly check-ins for 6 weeks
Passive range of motion (ROM) - changes from Baseline
Range of motion with selected movements measured by the Tardieu Spasticity Scale
Time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention
Directional Mobility Assessment (DMA) - changes from Baseline
Simple 10-item functional walking course; scoring key from 0-4
Time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention
The Sitting Assessment for Children with Neuromotor Dysfunction (SACND) - changes from Baseline
Evaluates postural tone, proximal stability, postural alignment and balance in sitting on a scale of 1-4
Time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention
PEDI-CAT Questionnaire - changes from Baseline
Qualitative parent-report for child's physical and social communication function domains
Time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention
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