Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

Holland Bloorview Kids Rehabilitation Hospital

Status

Invitation-only

Conditions

Cerebral Palsy

Treatments

Device: Trexo Plus Pediatric Exoskeleton

Study type

Interventional

Funder types

Other

Identifiers

NCT05463211

REB 0523

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

4 to 7 years old

Volunteers

No 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)