Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments
- Conditions
- Cerebral Palsy
- Interventions
- Device: Trexo Plus Pediatric Exoskeleton
- Registration Number
- NCT05463211
- Lead Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10
- 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).
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trexo Plus Pediatric Exoskeleton Trexo Plus Pediatric Exoskeleton Experimental lower-limb wearable pediatric exoskeleton used biweekly in clinical and school settings.
- Primary Outcome Measures
Name Time Method 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
Mechanomyography (MMG) - changes from Baseline Baselines, following 6 weeks of intervention, 1 month post-intervention Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)
Canadian Occupational Performance Measure (COPM) - changes from Baseline Weekly check-ins for 6 weeks Parent reported qualitative questionnaire for gait related goals
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
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
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
- Secondary Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Holland Bloorview Kids Rehabilitation Hospital
🇨🇦Toronto, Ontario, Canada