Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Trexo Plus Pediatric Exoskeleton

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 1R8
      • Holland Bloorview Kids Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Holland Bloorview Kids Rehabilitation Hospital
• Collaborators: University of Toronto

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (ACTUAL): July 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric exoskeleton; Robot assisted gait therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: REB 0523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, IPD will remain anonymous unless a data sharing agreement is made.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No