ParaplegiaRWNCT00627107
A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit
A study testing ReWalk - a motorized exoskeleton suit in people with Paraplegia and SCI, run by ReWalk Robotics, Inc. at 1 site in Israel.
Trial summary
The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Paraplegia, 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
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to Jan 2009
- 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
- Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
- Age between 18-55
- Male and non-pregnant non-lactating female
- Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
- under 100 kg and between 155-200 cm of height
Who cannot join
- History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
- Severe concurrent medical diseases: infections, heart or lung, pressure sores
- Unstable spine or unhealed limbs or pelvic fractures
- Psychiatric or cognitive situations that may interfere with the study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center, Neurological Rehabilitation Department
Tel HaShomer, 52621
About this study
Official title: Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.
The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.
Read the detailed description
The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.
- Conditions
- Paraplegia, SCI
- Being tested
- ReWalk - a motorized exoskeleton suit
- Keywords
- ReWalk, Paraplegia, SCI
- Medical subject headings
- Paraplegia
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 |
|---|---|---|
| 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.
Observation and subject feedback
Measured: 3 months
Secondary outcomes (1)
subject tolerance
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 posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReWalk Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gabi Zeilig, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627107
- Sponsor's protocol ID
- RW-002
- Acronym
- RW
- Status last verified
- Nov 2010
- First submitted
- 21 Feb 2008
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.
- ClinicalTrials.gov ID
- NCT00627107
- Acronym / sponsor ID
- RW / RW-002
- Conditions
- Paraplegia, SCI
- Keywords
- ReWalk, Paraplegia, SCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- ReWalk Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Feb 2008 (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.
The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.
Detailed description
The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 (5 listed)
- Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
- Age between 18-55
- Male and non-pregnant non-lactating female
- Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
- under 100 kg and between 155-200 cm of height
Key exclusion criteria (4 listed)
- History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
- Severe concurrent medical diseases: infections, heart or lung, pressure sores
- Unstable spine or unhealed limbs or pelvic fractures
- Psychiatric or cognitive situations that may interfere with the study
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 | A |
Primary outcome
Observation and subject feedback
Time frame: 3 months
1 secondary outcome
subject tolerance
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 30 Nov 2010.
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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.
Gabi Zeilig, MD principal investigator
Sheba Medical Center
1 site in 1 country: 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 SCI, run by ReWalk Robotics, Inc. at 1 site in Israel.
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 5 inclusion and 4 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 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Observation and subject feedback (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 30 Nov 2010.