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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trexo Plus Pediatric Exoskeleton | Experimental | Experimental lower-limb wearable pediatric exoskeleton used biweekly in clinical and school settings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trexo Plus Pediatric Exoskeleton | Device | Wearable pediatric robotic walker for the lower extremities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Measure (GMFM)-88 - changes from Baseline | Standard for measuring gross motor skills in children with CP and related neuromotor disorders | Baselines, following 6 weeks of intervention, 1 month post-intervention |
| Mechanomyography (MMG) - changes from Baseline | Non-invasive acoustic skeletal muscle recordings (frequency and amplitude) | 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 | 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 | 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 | 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 | Weekly check-ins for 6 weeks |
| Goal Attainment Scaling (GAS) - changes from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Passive range of motion (ROM) - changes from Baseline | Range of motion with selected movements measured by the Tardieu Spasticity Scale | Baselines, following 6 weeks of intervention, 1 month post-intervention |
| Directional Mobility Assessment (DMA) - changes from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Chau | Holland Bloorview Kids Rehabilitation Hospital | Principal Investigator |
| Virginia Wright | Holland Bloorview Kids Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G 1R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39145294 | Derived | Bradley SS, de Holanda LJ, Chau T, Wright FV. Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments. Front Neurosci. 2024 Jul 31;18:1398459. doi: 10.3389/fnins.2024.1398459. eCollection 2024. |
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At this time, IPD will remain anonymous unless a data sharing agreement is made.
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2 |
| Weekly check-ins for 6 weeks |
Simple 10-item functional walking course; scoring key from 0-4 |
| 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 | 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 | Baselines, following 6 weeks of intervention, 1 month post-intervention |