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

NCT ID: NCT01251549

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-03-31

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.

Conditions

Paraplegia; Spinal Cord Injuries (SCI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental: A

A group of paraplegics.

Group Type: EXPERIMENTAL

ReWalk - a motorized exoskeleton suit

Intervention Type: DEVICE

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

Interventions

ReWalk - a motorized exoskeleton suit

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

Intervention Type: DEVICE

Other Intervention Names

Exoskeleton suit

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReWalk Robotics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Esquenazi, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Medical Center, Moss Rehabilitation Center

Locations

Albert Einstein Medical Center, Moss Rehabilitation Center

Elkins Park, Pennsylvania, United States

Ospedale Valduce di Como, Centro Villa Beretta Italy

Como, , Italy

Countries

United States; Italy

Other Identifiers

RW003 ver. 4

Identifier Type: -

Identifier Source: org_study_id