Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Trexo Plus Pediatric Exoskeleton

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

Group Type EXPERIMENTAL

Trexo Plus Pediatric Exoskeleton

Intervention Type DEVICE

Wearable pediatric robotic walker for the lower extremities

Interventions

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Trexo Plus Pediatric Exoskeleton

Wearable pediatric robotic walker for the lower extremities

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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).

* 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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No