Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

NCT05463211 | Unknown

• 1 other identifier: REB 0523
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Pediatric exoskeleton; Robot assisted gait therapy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Passive range of motion (ROM) - changes from Baseline

  Baselines, following 6 weeks of intervention, 1 month post-intervention

• Directional Mobility Assessment (DMA) - changes from Baseline

  Baselines, following 6 weeks of intervention, 1 month post-intervention

• The Sitting Assessment for Children with Neuromotor Dysfunction (SACND) - changes from Baseline

  Baselines, following 6 weeks of intervention, 1 month post-intervention

• PEDI-CAT Questionnaire - changes from Baseline

  Baselines, following 6 weeks of intervention, 1 month post-intervention

Study Arms (1)

Trexo Plus Pediatric Exoskeleton

EXPERIMENTAL

Experimental lower-limb wearable pediatric exoskeleton used biweekly in clinical and school settings.

Device: Trexo Plus Pediatric Exoskeleton

Interventions

Trexo Plus Pediatric Exoskeleton DEVICE

Wearable pediatric robotic walker for the lower extremities

Trexo Plus Pediatric Exoskeleton

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Weight of 50-100 lbs (23- 46 kgs), leg length (hip to floor): 40-56c
• GMFCS Level IV equivalent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• University of Toronto: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

• Bradley SS, de Holanda LJ, Chau T, Wright FV. Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments. Front Neurosci. 2024 Jul 31;18:1398459. doi: 10.3389/fnins.2024.1398459. eCollection 2024.

  PMID: 39145294 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tom Chau

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Virginia Wright

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: July 18, 2022
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CA (1)