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| Name | Class |
|---|---|
| Shirley Ryan AbilityLab | OTHER |
| Kessler Foundation | OTHER |
| TIRR Memorial Hermann | OTHER |
| Spaulding Rehabilitation Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational group | Experimental | All subjects will participate in study procedures involving use of the ReWalk ReStore device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReWalk ReStore device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | duration of study participation for each subject, estimated 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | duration of study completion for each site, estimated 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | duration of study participation for each subject, estimated 4 weeks |
| Gait analysis using a gait mat |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States | ||
| Spaulding Rehabilitation Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32552775 | Derived | 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. |
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| OTHER |
| Moss Rehabilitation Research Institute | OTHER |
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| 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. |
| duration of study completion for each site, estimated 4 months |
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.
| 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 | 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. | 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. | duration of study completion for each site, estimated 4 months |
| Boston |
| Massachusetts |
| 02129 |
| United States |
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
| Moss Rehab | Elkins Park | Pennsylvania | 19027 | United States |
| TIRR Memorial Hermann | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083302 | Hemorrhagic Stroke |
| D010291 | Paresis |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |
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