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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01251549

Enrollment

Registered

2010-12-02

Start date

2009-03-31

Completion date

2013-03-31

Last updated

2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraplegia, Spinal Cord Injuries (SCI)

Keywords

ReWalk, Paraplegia, Spinal Cord Injuries (SCI)

Brief summary

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.

Interventions

DEVICEReWalk - a motorized exoskeleton suit

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of use	3 months	Number of participants with related adverse events as a Measure of Safety and Tolerability

Secondary

Measure	Time frame	Description
Efficacy	3 months	Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals

Countries

Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026