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Cerebral PalsyNCT05463211

Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

A study testing Trexo Plus Pediatric Exoskeleton in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 4 to 7 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Trexo Plus Pediatric Exoskeleton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
Mar 2023to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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)
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G 1R8

Other trials in Canada

About this study

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

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
Being tested
Trexo Plus Pediatric Exoskeleton
Keywords
Pediatric exoskeleton, Robot assisted gait therapy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trexo Plus Pediatric ExoskeletonDevice

    Wearable pediatric robotic walker for the lower extremities

Study groups in NCT05463211
Study groupRoleWhat they receive
Trexo Plus Pediatric ExoskeletonExperimentalExperimental lower-limb wearable pediatric exoskeleton used biweekly in clinical and school settings.
Receives: Device: Trexo Plus Pediatric Exoskeleton

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gross Motor Function Measure (GMFM)-88 - changes from Baseline

    Standard for measuring gross motor skills in children with CP and related neuromotor disorders

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

  2. Mechanomyography (MMG) - changes from Baseline

    Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)

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

  3. Structural Magnetic resonance Imaging (MRI) - changes from Baseline

    T1 anatomical scan - grey and white matter volumes

    Measured: Baseline, following 6 weeks of intervention, 1 month post-intervention

  4. Diffusion Magnetic resonance imaging (MRI) - changes from Baseline

    Multi shell diffusion imaging - kurtosis fractional anisotropy measures

    Measured: Baseline, following 6 weeks of intervention, 1 month post-intervention

  5. Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline

    Whole-brain analysis based on BOLD signal changes

    Measured: Baseline, following 6 weeks of intervention, 1 month post-intervention

  6. Canadian Occupational Performance Measure (COPM) - changes from Baseline

    Parent reported qualitative questionnaire for gait related goals

    Measured: Weekly check-ins for 6 weeks

  7. Goal Attainment Scaling (GAS) - changes from Baseline

    Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2

    Measured: Weekly check-ins for 6 weeks

Secondary outcomes (4)

  1. Passive range of motion (ROM) - changes from Baseline

    Range of motion with selected movements measured by the Tardieu Spasticity Scale

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

  2. Directional Mobility Assessment (DMA) - changes from Baseline

    Simple 10-item functional walking course; scoring key from 0-4

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

  3. 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

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

  4. PEDI-CAT Questionnaire - changes from Baseline

    Qualitative parent-report for child's physical and social communication function domains

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study startMar 2023 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463211
Sponsor's protocol ID
REB 0523
Status last verified
Feb 2023
First submitted
8 Jun 2022
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: At this time, IPD will remain anonymous unless a data sharing agreement is made.

Publications

  • 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.

    PubMed 39145294

Questions about this trial

What is this clinical trial studying?

A study testing Trexo Plus Pediatric Exoskeleton in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross Motor Function Measure (GMFM)-88 - changes from Baseline (time frame: Baselines, following 6 weeks of intervention, 1 month post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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Clinical Trial NCT05463211 | AzTrials