Safety and Performance Evaluation of ReWalk Reciprocating... | NCT01251549

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

NCT01251549

Sponsor

ReWalk Robotics, Inc.

Status

Completed

Last Update Posted

Oct 5, 2016Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Paraplegia
Spinal Cord Injuries (SCI)

Interventions

ReWalk - a motorized exoskeleton suit

Countries

United States
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 28, 2010

First Submission Date that Met QC Criteria

Nov 30, 2010

First Posted Date

Dec 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2016

Last Update Posted Date

Oct 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: A	Experimental	A group of paraplegics.	Device: ReWalk - a motorized exoskeleton suit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ReWalk - a motorized exoskeleton suit	Device	The subject will wear the ReWalk suit and have training sessions for walking with the device	Experimental: A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alberto Esquenazi, MD	Albert Einstein Medical Center, Moss Rehabilitation Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albert Einstein Medical Center, Moss Rehabilitation Center		Elkins Park	Pennsylvania	19027	United States

Condition Browse Module

MeSH Terms

ID	Term
D010264	Paraplegia
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D010243	Paralysis
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided