An interventional study of ReWalk ReStore device in Stroke, Stroke, Acute and Stroke Hemorrhagic, sponsored by ReWalk Robotics, Inc.. Status unknown at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by ReWalk Robotics, Inc. · Not applicable, Interventional, and Other
Among 76 studies in Hemorrhagic Stroke with a site in United States — 22 open to participants now, 28 under way, 1 of them phase 3. Hemorrhagic Stroke · United States.
Among the 76 studies in Hemorrhagic Stroke with a site in United States, this one is the 25th largest by planned enrollment of the 57 interventional ones that give a count, is one of 5 that started in 2018, is one of 41 with no phase, and was the 23rd registered.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's planned enrollment of 40 is below the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →22 of the 76 studies in Hemorrhagic Stroke with a site in United States are open now, in 10 countries. Each count lists the studies.
Of the 62 Hemorrhagic Stroke studies recruiting now, 36 (58%) set no upper age limit and 7 (11%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →76 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 5 started in 2018.
Median enrollment 30 across the 57 interventional studies, 300 across the 19 observational. Of the 45 that completed or were terminated, 17 (38%) have results posted.
14 of 76 have an industry lead sponsor. The 10 most frequent:
ReWalk Robotics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
ReWalk Robotics, Inc. has 1 study filed under Hemorrhagic Stroke — fewer than ten, so there is no comparison to draw.
12 of the studies in Hemorrhagic Stroke with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06999122EMVision Medical Devices LtdDiagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients | 2026-11-01 |
| NCT07649135University of MinnesotaFeasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke | 2026-11-30 |
| NCT05085210Beth Israel Deaconess Medical CenterImproving Visual Field Deficits With Noninvasive Brain Stimulation | 2026-12 |
| NCT04534556Baylor Research InstituteWireless Nerve Stimulation Device To Enhance Recovery After Stroke | 2027-01-01 |
| NCT07053917Johns Hopkins UniversityPsychedelic Healing: Adjunct Therapy Harnessing Opened Malleability | 2027-02 |
Among the 76 studies in Hemorrhagic Stroke with a site in United States, from their registry updates:
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.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's planned enrollment of 40 is below the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →ReWalk Robotics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Compared within Hemorrhagic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All subjects will participate in study procedures involving use of the ReWalk ReStore device.
Device: ReWalk ReStore device
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.
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.
Time frame: duration of study participation for each subject, estimated 4 weeks
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.
Time frame: 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.
Time frame: duration of study completion for each site, estimated 4 months
Gait speed measured with 10 Meter Walk Test
Subjects will perform a 10 Meter Walk Test to evaluate walking speed with and without the ReStore device.
Time frame: duration of study participation for each subject, estimated 4 weeks
Gait analysis using a gait mat
Subjects will walk across a gait mat device (such as GAITRite) which records step timing and step placement in order to evaluate their walking with and without the ReStore device.
Time frame: duration of study participation for each subject, estimated 4 weeks
Walking distance measured with 2 Minute Walk Test
Subjects will perform a 2 Minute Walk Test (2MWT) to evaluate the 2 minute walking distance with the ReStore device in Slack, Assist, and Brace modes
Time frame: duration of study participation for each subject, estimated 4 weeks
Modified QUEST questionnaire [subject satisfaction]
Subjects will complete a modified QUEST questionnaire (Quebec User Evaluation of Assistive Technology) to indicate their level of satisfaction with the ReStore device (on a scale from 1 to 5) in 8 different categories.
Time frame: duration of study participation for each subject, estimated 4 weeks
Physical Therapist satisfaction questionnaire [PT satisfaction]
Physical Therapists involved in the study will complete a PT satisfaction questionnaire at the end of the study to indicate their level of satisfaction (on a scale from 1 to 5) with the ReStore device in 9 different categories.
Time frame: duration of study completion for each site, estimated 4 months
Plan to share: No
Started Mar 2018 (actual). Primary completion is estimated for Nov 2018, 8 months after the start.
Of 89 interventional studies with no phase under Hemorrhagic Stroke, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 56. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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ReWalk Robotics, Inc.