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

Primary Purpose

Paraplegia, Spinal Cord Injuries (SCI)

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

ReWalk - a motorized exoskeleton suit

About this trial

This is an interventional supportive care trial for Paraplegia focused on measuring ReWalk, Paraplegia, Spinal Cord Injuries (SCI)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Albert Einstein Medical Center, Moss Rehabilitation Center
Ospedale Valduce di Como, Centro Villa Beretta Italy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: A

Arm Description

A group of paraplegics.

Outcomes

Primary Outcome Measures

Safety of use

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

Secondary Outcome Measures

Efficacy

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

Full Information

NCT ID

NCT01251549

First Posted

November 28, 2010

Last Updated

October 4, 2016

Sponsor

ReWalk Robotics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01251549

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ReWalk Robotics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paraplegia, Spinal Cord Injuries (SCI)

Keywords

ReWalk, Paraplegia, Spinal Cord Injuries (SCI)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: A

Arm Type

Experimental

Arm Description

A group of paraplegics.

Intervention Type

Device

Intervention Name(s)

ReWalk - a motorized exoskeleton suit

Other Intervention Name(s)

Exoskeleton suit

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety of use

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Efficacy

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberto Esquenazi, MD

Organizational Affiliation

Albert Einstein Medical Center, Moss Rehabilitation Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Albert Einstein Medical Center, Moss Rehabilitation Center

City

Elkins Park

State/Province

Pennsylvania

ZIP/Postal Code

19027

Country

United States

Facility Name

Ospedale Valduce di Como, Centro Villa Beretta Italy

City

Como

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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