Indications and safety information

Indication for Use

The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients 12 years and older with cerebral palsy.

The Trexo Theo is intended to be used in a community setting under the supervision of a trained companion who has been certified to the companion training program prior to use of the device. The device is also intended to be used in a clinical setting under the supervision of a trained therapist who has been certified to the therapist training program prior to use of the device.

The Trexo Theo is not intended for sports or stair climbing.

Prescription device. Federal law restricts this device to sale by or on the order of a physician. Users are re-evaluated by a physical or occupational therapist at least annually.

Contraindications

Trexo Theo must not be used by a person with any of the following:

• Knee flexion contracture greater than 30°
• Severe knee valgus that cannot be corrected
• Hip flexion contracture (unable to reach 0° hip extension)
• Severe spasticity (Modified Ashworth grade 4)
• Weight-bearing restrictions, including recent orthopaedic surgery or hip subluxation concerns
• History or suspicion of lower-limb fragility fracture (e.g. osteogenesis imperfecta, osteoporosis, osteopenia)
• Unable to communicate discomfort or pain, including through non-verbal cues

Precautions

The following require clinical judgement before use and should be discussed with the prescribing physician:

• Hip dysplasia or subluxation with pain
• Severe scoliosis
• Severe joint or bony deformities
• Significant involuntary movement disorders, or uncontrolled epilepsy/seizures
• Severe concurrent illness or pressure sores
• Psychiatric or behavioural conditions that make supervised use unsafe
• Implanted programmable devices or feeding tubes (positioning and strap placement reviewed by a clinician)

Supervision, sizing and training

Every session is supervised by a companion or therapist who has completed Trexo's certification, within arm's reach for the whole session. The device is fitted by a Trexo Certified Trainer from measurements taken by the child's own therapist, and adjusted as the child grows, up to 150 lb. Trexo Theo is not intended for sports or stair climbing. See sizing and how it works for the process.

Individual results vary. Talk to your child's clinician about whether Trexo Theo is appropriate. Full Instructions for Use ship with the device and are available on request at hello@trexorobotics.com. Clinicians: see for clinicians.