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Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

Primary Purpose

Cerebral Palsy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Trexo Plus Pediatric Exoskeleton
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cerebral Palsy focused on measuring Pediatric exoskeleton, Robot assisted gait therapy

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trexo Plus Pediatric Exoskeleton

Arm Description

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

Outcomes

Primary Outcome Measures

Gross Motor Function Measure (GMFM)-88 - changes from Baseline
Standard for measuring gross motor skills in children with CP and related neuromotor disorders
Mechanomyography (MMG) - changes from Baseline
Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)
Structural Magnetic resonance Imaging (MRI) - changes from Baseline
T1 anatomical scan - grey and white matter volumes
Diffusion Magnetic resonance imaging (MRI) - changes from Baseline
Multi shell diffusion imaging - kurtosis fractional anisotropy measures
Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline
Whole-brain analysis based on BOLD signal changes
Canadian Occupational Performance Measure (COPM) - changes from Baseline
Parent reported qualitative questionnaire for gait related goals
Goal Attainment Scaling (GAS) - changes from Baseline
Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2

Secondary Outcome Measures

Passive range of motion (ROM) - changes from Baseline
Range of motion with selected movements measured by the Tardieu Spasticity Scale
Directional Mobility Assessment (DMA) - changes from Baseline
Simple 10-item functional walking course; scoring key from 0-4
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
PEDI-CAT Questionnaire - changes from Baseline
Qualitative parent-report for child's physical and social communication function domains

Full Information

First Posted
June 8, 2022
Last Updated
February 6, 2023
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05463211
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
University of Toronto

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Pediatric exoskeleton, Robot assisted gait therapy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trexo Plus Pediatric Exoskeleton
Arm Type
Experimental
Arm Description
Experimental lower-limb wearable pediatric exoskeleton used biweekly in clinical and school settings.
Intervention Type
Device
Intervention Name(s)
Trexo Plus Pediatric Exoskeleton
Intervention Description
Wearable pediatric robotic walker for the lower extremities
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM)-88 - changes from Baseline
Description
Standard for measuring gross motor skills in children with CP and related neuromotor disorders
Time Frame
Baselines, following 6 weeks of intervention, 1 month post-intervention
Title
Mechanomyography (MMG) - changes from Baseline
Description
Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)
Time Frame
Baselines, following 6 weeks of intervention, 1 month post-intervention
Title
Structural Magnetic resonance Imaging (MRI) - changes from Baseline
Description
T1 anatomical scan - grey and white matter volumes
Time Frame
Baseline, following 6 weeks of intervention, 1 month post-intervention
Title
Diffusion Magnetic resonance imaging (MRI) - changes from Baseline
Description
Multi shell diffusion imaging - kurtosis fractional anisotropy measures
Time Frame
Baseline, following 6 weeks of intervention, 1 month post-intervention
Title
Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline
Description
Whole-brain analysis based on BOLD signal changes
Time Frame
Baseline, following 6 weeks of intervention, 1 month post-intervention
Title
Canadian Occupational Performance Measure (COPM) - changes from Baseline
Description
Parent reported qualitative questionnaire for gait related goals
Time Frame
Weekly check-ins for 6 weeks
Title
Goal Attainment Scaling (GAS) - changes from Baseline
Description
Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2
Time Frame
Weekly check-ins for 6 weeks
Secondary Outcome Measure Information:
Title
Passive range of motion (ROM) - changes from Baseline
Description
Range of motion with selected movements measured by the Tardieu Spasticity Scale
Time Frame
Baselines, following 6 weeks of intervention, 1 month post-intervention
Title
Directional Mobility Assessment (DMA) - changes from Baseline
Description
Simple 10-item functional walking course; scoring key from 0-4
Time Frame
Baselines, following 6 weeks of intervention, 1 month post-intervention
Title
The Sitting Assessment for Children with Neuromotor Dysfunction (SACND) - changes from Baseline
Description
Evaluates postural tone, proximal stability, postural alignment and balance in sitting on a scale of 1-4
Time Frame
Baselines, following 6 weeks of intervention, 1 month post-intervention
Title
PEDI-CAT Questionnaire - changes from Baseline
Description
Qualitative parent-report for child's physical and social communication function domains
Time Frame
Baselines, following 6 weeks of intervention, 1 month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Chau
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginia Wright
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
At this time, IPD will remain anonymous unless a data sharing agreement is made.

Learn more about this trial

Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

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