Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke (NCT03499210) | Clinical Trial Compass
UnknownNot Applicable
Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke
United States40 participantsStarted 2018-03-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of device-related adverse events [Safety]
Timeframe: duration of study participation for each subject, estimated 4 weeks