Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05463211
• Other study ID #: REB 0523
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2023
• Est. completion date: September 2023

Study information

• Verified date: February 2023
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Trexo Plus Pediatric Exoskeleton
Wearable pediatric robotic walker for the lower extremities

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mechanomyography (MMG) - changes from Baseline	Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)	Baselines, following 6 weeks of intervention, 1 month post-intervention
Primary	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
Primary	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
Primary	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
Primary	Canadian Occupational Performance Measure (COPM) - changes from Baseline	Parent reported qualitative questionnaire for gait related goals	Weekly check-ins for 6 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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