Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)

ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.

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Key information

Conditions

Paraplegia Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injuries (SCI) Trauma, Nervous System Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Valduce di Como, Centro Villa Beretta Italy, Como, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Complete cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal Injury Association (ASIA) guidelines
Male and non-pregnant non-lactating female Age 18-55
At least 6 months after injury
Regular use of RGO (Reciprocating Gait Orthosis) or KAFO's (Knee Ankle Foot Orthoses) or able to stand using a standing device (e.g., 'Easy stand')
Patients must be capable of providing informed consent
Height of 160 to 190 cm
Weight of <100 kg

Exclusion criteria

History of severe neurological injuries other than SCI (Spinal Cord Injuries)(MS (Multiple Sclerosis), CP (Cerebral Palsy), ALS (Amyotrophic Lateral Sclerosis) , TBI (Traumatic Brain Injury) etc)
Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
Severe spasticity (Ashworth 4) or uncontrolled clonus
Unstable spine or unhealed limbs or pelvic fractures
Heterotopic ossification
Significant contractures
Psychiatric or cognitive situations that may interfere with the trial

Treatment and study plan

ReWalk - a motorized exoskeleton suit

Device

The subject will wear the ReWalk suit and have training sessions for walking with the device

Other names: Exoskeleton suit

Primary outcomes

Safety of use

Time frame: 3 months

Number of participants with related adverse events as a Measure of Safety and Tolerability

Secondary outcomes

Efficacy

Time frame: 3 months

Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals

Sponsors and collaborators

Lead sponsor

ReWalk Robotics, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Dec 2, 2010
Registry last updated: Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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