NCT01251549

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

November 28, 2010

Last Update Submit

October 4, 2016

Conditions

ParaplegiaSpinal Cord Injuries (SCI)

Keywords

ReWalkParaplegiaSpinal Cord Injuries (SCI)

Outcome Measures

Primary Outcomes (1)

  • Safety of use

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

    3 months

Secondary Outcomes (1)

  • Efficacy

    3 months

Study Arms (1)

Experimental: A

EXPERIMENTAL

A group of paraplegics.

Device: ReWalk - a motorized exoskeleton suit

Interventions

ReWalk - a motorized exoskeleton suitDEVICE

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

Also known as: Exoskeleton suit
Experimental: A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albert Einstein Medical Center, Moss Rehabilitation Center

Elkins Park, Pennsylvania, 19027, United States

Location

Ospedale Valduce di Como, Centro Villa Beretta Italy

Como, Italy

Location

MeSH Terms

Conditions

ParaplegiaSpinal Cord Injuries

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Alberto Esquenazi, MD

    Albert Einstein Medical Center, Moss Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2010

First Posted

December 2, 2010

Study Start

March 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

US(1)IT(1)