StrokeNCT03499210
Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke
A study testing ReWalk ReStore device in people with Stroke and Stroke, Acute, run by ReWalk Robotics, Inc. at 5 sites in United States.
Trial summary
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke Hemorrhagic
- What is being tested?
- ReWalk ReStore device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Mar 2018to 30 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of one-sided ischemic or hemorrhagic stroke (>2 weeks post stroke)
- Presentation of hemiparesis/hemiplegia resulting from stroke
- At least 18 years of age
- Height of 4'8" - 6'7"
- Weight of less than 264 lbs
- Medical clearance by a clinician treating the subject
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- Able to ambulate at least 5 feet without an ankle foot orthosis (AFO), with no more than minimal contact assistance from a PT
- Able to follow a 3-step command
- Able to fit suit components (waistbelt, calf wrap)
- No greater than 5 degrees of plantar flexion contracture during passive ankle ROM
- Modified Ashworth Scale for spasticity at 3 or less for ankle dorsi-flexors and plantar-flexors
Who cannot join
- Severe aphasia limiting ability to express needs or discomfort verbally or non-verbally
- Serious co-morbidities that, in the opinion of the investigator, may interfere with ability to participate
- History of significant Peripheral Artery Disease
- Colostomy bag
- Current pregnancy
- Uncontrolled or untreated hypertension
Show all 10Show fewer
- Currently participating in any other ongoing clinical trial
- Presence of open wounds or broken skin at device locations requiring medical management
- Known urethane allergies
- Current medical diagnosis of DVT
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Spaulding Rehabilitation Institute
Boston, Massachusetts, 02129
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Moss Rehab
Elkins Park, Pennsylvania, 19027
TIRR Memorial Hermann
Houston, Texas, 77030
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: A Multi-site, Interventional, Non-comparative, Single-arm Trial to Evaluate the Safety of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Ischemic or Hemorrhagic Stroke
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.
- Conditions
- Stroke, Stroke, Acute, Stroke Hemorrhagic, Hemiparesis, Hemiplegia, Cerebrovascular Accident
- Being tested
- ReWalk ReStore device
- Keywords
- Stroke, Exoskeleton, Hemiparesis, Hemiplegia
- Medical subject headings
- Stroke, Hemorrhagic Stroke, Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReWalk ReStore deviceDevice
The ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
| Study group | Role | What they receive |
|---|---|---|
| Investigational group | Experimental | All subjects will participate in study procedures involving use of the ReWalk ReStore device. Receives: Device: ReWalk ReStore device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related adverse events [Safety]
Safety will be evaluated on the basis of the number of device-related adverse events reported for subjects during their participation in the study.
Measured: duration of study participation for each subject, estimated 4 weeks
Secondary outcomes (2)
Incidence of device malfunctions during study procedures [Device Reliability]
Device reliability will be evaluated on the basis of the number of device malfunctions reported by research study staff for the duration of study procedures at each study site.
Measured: duration of study completion for each site, estimated 4 months
Incidence of injury to physical therapist caused by device [PT safety]
PT safety will be evaluated on the basis of the number of device-related injuries reported by study physical therapists for the duration of study procedures at each study site.
Measured: duration of study completion for each site, estimated 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start29 Mar 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReWalk Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shirley Ryan AbilityLab, Kessler Foundation, TIRR Memorial Hermann, Spaulding Rehabilitation Hospital, Moss Rehabilitation Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499210
- Sponsor's protocol ID
- CLN0011
- Status last verified
- Nov 2018
- First submitted
- 27 Mar 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Awad LN, Esquenazi A, Francisco GE, Nolan KJ, Jayaraman A. The ReWalk ReStore soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation. J Neuroeng Rehabil. 2020 Jun 18;17(1):80. doi: 10.1186/s12984-020-00702-5.
PubMed 32552775
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Interventional, Non-comparative, Single-arm Trial to Evaluate the Safety of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Ischemic or Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT03499210
- Acronym / sponsor ID
- CLN0011
- Conditions
- Stroke, Stroke, Acute, Stroke Hemorrhagic, Hemiparesis, Hemiplegia, Cerebrovascular Accident
- Keywords
- Stroke, Exoskeleton, Hemiparesis, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ReWalk Robotics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shirley Ryan AbilityLab, Kessler Foundation, TIRR Memorial Hermann, Spaulding Rehabilitation Hospital, Moss Rehabilitation Research Institute
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 17 Apr 2018 (actual)
- 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.
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational group | Experimental | Device: ReWalk ReStore deviceAll subjects will participate in study procedures involving use of the ReWalk ReStore device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- History of one-sided ischemic or hemorrhagic stroke (>2 weeks post stroke)
- Presentation of hemiparesis/hemiplegia resulting from stroke
- At least 18 years of age
- Height of 4'8" - 6'7"
- Weight of less than 264 lbs
Key exclusion criteria (10 listed)
- Severe aphasia limiting ability to express needs or discomfort verbally or non-verbally
- Serious co-morbidities that, in the opinion of the investigator, may interfere with ability to participate
- History of significant Peripheral Artery Disease
- Colostomy bag
- Current pregnancy
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 ReStore deviceThe ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke. | Device | Investigational group |
Primary outcome
Incidence of device-related adverse events [Safety]
Time frame: duration of study participation for each subject, estimated 4 weeks
Safety will be evaluated on the basis of the number of device-related adverse events reported for subjects during their participation in the study.
2 secondary outcomes
Incidence of device malfunctions during study procedures [Device Reliability]
Time frame: duration of study completion for each site, estimated 4 months
Incidence of injury to physical therapist caused by device [PT safety]
Time frame: duration of study completion for each site, estimated 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Derived from this study: PubMed 32552775Awad LN, Esquenazi A, Francisco GE, Nolan KJ, Jayaraman A. The ReWalk ReStore soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation. J Neuroeng Rehabil. 2020 Jun 18;17(1):80. doi: 10.1186/s12984-020-00702-5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReWalk ReStore device in people with Stroke and Stroke, Acute, run by ReWalk Robotics, Inc. at 5 sites in United States.
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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Results are not available in the source record.
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?
Incidence of device-related adverse events [Safety] (time frame: duration of study participation for each subject, estimated 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499210, which also lists 1 linked publication.
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 7 Nov 2018.