Clinical trial NCT05463211: Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments
Official title: Quantifying the User Experience, as Well as Neural, Muscular, and Functional Gait Changes Following Exoskeleton-powered Gait Rehabilitation in Children With Mobility Impairments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Pediatric exoskeleton
Robot assisted gait therapy
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2022-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Gross Motor Function Measure (GMFM)-88 - changes from Baseline
timeFrame: Baselines, following 6 weeks of intervention, 1 month post-intervention
measure: Mechanomyography (MMG) - changes from Baseline
timeFrame: Baselines, following 6 weeks of intervention, 1 month post-intervention
measure: Structural Magnetic resonance Imaging (MRI) - changes from Baseline
timeFrame: Baseline, following 6 weeks of intervention, 1 month post-intervention
measure: Diffusion Magnetic resonance imaging (MRI) - changes from Baseline
timeFrame: Baseline, following 6 weeks of intervention, 1 month post-intervention
measure: Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline
timeFrame: Baseline, following 6 weeks of intervention, 1 month post-intervention
measure: Canadian Occupational Performance Measure (COPM) - changes from Baseline
timeFrame: Weekly check-ins for 6 weeks
measure: Goal Attainment Scaling (GAS) - changes from Baseline
timeFrame: Weekly check-ins for 6 weeks
Secondary outcomes:
measure: Passive range of motion (ROM) - changes from Baseline
timeFrame: Baselines, following 6 weeks of intervention, 1 month post-intervention
measure: Directional Mobility Assessment (DMA) - changes from Baseline
timeFrame: Baselines, following 6 weeks of intervention, 1 month post-intervention
measure: The Sitting Assessment for Children with Neuromotor Dysfunction (SACND) - changes from Baseline
timeFrame: Baselines, following 6 weeks of intervention, 1 month post-intervention
measure: PEDI-CAT Questionnaire - changes from Baseline
timeFrame: Baselines, following 6 weeks of intervention, 1 month post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Tom Chau
role: PRINCIPAL_INVESTIGATOR
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Virginia Wright
role: PRINCIPAL_INVESTIGATOR
References: