Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

Study Overview
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Brief Summary
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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.

Official Title
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Quantifying the User Experience, as Well as Neural, Muscular, and Functional Gait Changes Following Exoskeleton-powered Gait Rehabilitation in Children With Mobility Impairments

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Trexo Plus Pediatric Exoskeleton


Participation Criteria
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Eligibility Criteria
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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). Exclusion Criteria: Any weightbearing restrictions Fixed knee contracture (passive) > 20 degrees, knee valgus >40 degrees such that orthosis will not be adaptable to lower limbs. Note: Fixed hip and ankle contractures in themselves are not a contraindication for Trexo Hip subluxation > 40% unless with orthopedic clearance for weight bearing with the Trexo Orthopaedic surgery within the last 9 months (if muscle) or 12 months (if bone) Severe spasticity may be a contraindication (still OK to consider) Seizure disorder that is not controlled by medication. For a child on seizure medication, must not have had a seizure in the last 12 months (as verified by the child's treating physician) Open skin lesions or vascular disorder of lower extremities Osteogenesis imperfecta Not able to co-operate for positioning/adjustments within the Trexo Involved in another intervention study (any type). May be concurrently enrolled though in a single point assessment study (e.g., annual follow-up of status, measurement study)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trexo Plus Pediatric Exoskeleton<br>Experimental lower-limb wearable pediatric exoskeleton used biweekly in clinical and school settings. | Device: Trexo Plus Pediatric Exoskeleton<br>* Wearable pediatric robotic walker for the lower extremities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2 | Weekly check-ins for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric exoskeleton, Robot assisted gait therapy