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

Paraplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251549
• Other study ID #: RW003 ver. 4
• Status: Completed
• Phase: N/A
• First received: November 28, 2010
• Last updated: October 4, 2016
• Start date: March 2009
• Est. completion date: March 2013

Study information

• Verified date: October 2016
• Source: ReWalk Robotics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Paraplegia
• Spinal Cord Injuries
• Spinal Cord Injuries (SCI)

Intervention

Device:
• ReWalk - a motorized exoskeleton suit
The subject will wear the ReWalk suit and have training sessions for walking with the device

Locations

Country	Name	City	State
Italy	Ospedale Valduce di Como, Centro Villa Beretta Italy	Como
United States	Albert Einstein Medical Center, Moss Rehabilitation Center	Elkins Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ReWalk Robotics, Inc.

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of use	Number of participants with related adverse events as a Measure of Safety and Tolerability	3 months	Yes
Secondary	Efficacy	Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals	3 months	No