Cerebral Palsy
Conditions
Keywords
Pediatric exoskeleton, Robot assisted gait therapy
Brief summary
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.
Interventions
DEVICETrexo Plus Pediatric Exoskeleton
Wearable pediatric robotic walker for the lower extremities
Sponsors
University of Toronto
Holland Bloorview Kids Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Weight of 50-100 lbs (23- 46 kgs), leg length (hip to floor): 40-56c * GMFCS Level IV equivalent * Knee and hip range of motion sufficient to allow exoskeleton fit (see
Exclusion criteria
) * Able to follow GMFM testing instructions, and able to participate in a minimum of 30 minutes of active PT * Able to reliably signal pain, fear and discomfort * At least 2 months after any lower limb Botulinum Toxin (BTX) injections * Will be safe for BTX to be put on hold during their study participation (i.e., a period of 6 months which is equivalent to one BTX treatment cycle).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scaling (GAS) - changes from Baseline | Weekly check-ins for 6 weeks | Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2 |
| Structural Magnetic resonance Imaging (MRI) - changes from Baseline | Baseline, following 6 weeks of intervention, 1 month post-intervention | T1 anatomical scan - grey and white matter volumes |
| Diffusion Magnetic resonance imaging (MRI) - changes from Baseline | Baseline, following 6 weeks of intervention, 1 month post-intervention | Multi shell diffusion imaging - kurtosis fractional anisotropy measures |
| Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline | Baseline, following 6 weeks of intervention, 1 month post-intervention | Whole-brain analysis based on BOLD signal changes |
| Canadian Occupational Performance Measure (COPM) - changes from Baseline | Weekly check-ins for 6 weeks | Parent reported qualitative questionnaire for gait related goals |
| Gross Motor Function Measure (GMFM)-88 - changes from Baseline | Baselines, following 6 weeks of intervention, 1 month post-intervention | Standard for measuring gross motor skills in children with CP and related neuromotor disorders |
| Mechanomyography (MMG) - changes from Baseline | Baselines, following 6 weeks of intervention, 1 month post-intervention | Non-invasive acoustic skeletal muscle recordings (frequency and amplitude) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Directional Mobility Assessment (DMA) - changes from Baseline | Baselines, following 6 weeks of intervention, 1 month post-intervention | Simple 10-item functional walking course; scoring key from 0-4 |
| The Sitting Assessment for Children with Neuromotor Dysfunction (SACND) - changes from Baseline | Baselines, following 6 weeks of intervention, 1 month post-intervention | Evaluates postural tone, proximal stability, postural alignment and balance in sitting on a scale of 1-4 |
| PEDI-CAT Questionnaire - changes from Baseline | Baselines, following 6 weeks of intervention, 1 month post-intervention | Qualitative parent-report for child's physical and social communication function domains |
| Passive range of motion (ROM) - changes from Baseline | Baselines, following 6 weeks of intervention, 1 month post-intervention | Range of motion with selected movements measured by the Tardieu Spasticity Scale |
Countries
Canada
Outcome results
None listed