ParaplegiaNCT01251549
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
A study testing ReWalk - a motorized exoskeleton suit in people with Paraplegia and Spinal Cord Injuries (SCI), run by ReWalk Robotics, Inc. at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Paraplegia, Spinal Cord Injuries (SCI)
- What is being tested?
- ReWalk - a motorized exoskeleton suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Albert Einstein Medical Center, Moss Rehabilitation Center
Elkins Park, Pennsylvania, 19027
About this study
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)
- Being tested
- ReWalk - a motorized exoskeleton suit
- Keywords
- ReWalk, Paraplegia, Spinal Cord Injuries (SCI)
- Medical subject headings
- Paraplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReWalk - a motorized exoskeleton suitDevice
Also called Exoskeleton suit
The subject will wear the ReWalk suit and have training sessions for walking with the device
| Study group | Role | What they receive |
|---|---|---|
| Experimental: A | Experimental | A group of paraplegics. Receives: Device: ReWalk - a motorized exoskeleton suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of use
Number of participants with related adverse events as a Measure of Safety and Tolerability
Measured: 3 months
Secondary outcomes (1)
Efficacy
Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReWalk Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Esquenazi, MD, Principal investigator, Albert Einstein Medical Center, Moss Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251549
- Sponsor's protocol ID
- RW003 ver. 4
- Status last verified
- Oct 2016
- First submitted
- 28 Nov 2010
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
- ClinicalTrials.gov ID
- NCT01251549
- Acronym / sponsor ID
- RW003 ver. 4
- Conditions
- Paraplegia, Spinal Cord Injuries (SCI)
- Keywords
- ReWalk, Paraplegia, Spinal Cord Injuries (SCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ReWalk Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: A | Experimental | Device: ReWalk - a motorized exoskeleton suitA group of paraplegics. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReWalk - a motorized exoskeleton suitAlso: Exoskeleton suitThe subject will wear the ReWalk suit and have training sessions for walking with the device | Device | Experimental: A |
Primary outcome
Safety of use
Time frame: 3 months
Number of participants with related adverse events as a Measure of Safety and Tolerability
1 secondary outcome
Efficacy
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Esquenazi, MD principal investigator
Albert Einstein Medical Center, Moss Rehabilitation Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReWalk - a motorized exoskeleton suit in people with Paraplegia and Spinal Cord Injuries (SCI), run by ReWalk Robotics, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of use (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.