NCT03499210UnknownNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- ReWalk Robotics, Inc.
- Enrollment
- 40
- Locations
- 10
- Primary Endpoint
- Incidence of device-related adverse events [Safety]
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Investigational group
Experimental
All subjects will participate in study procedures involving use of the ReWalk ReStore device.
Intervention: ReWalk ReStore device (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Incidence of device malfunctions during study procedures [Device Reliability](duration of study completion for each site, estimated 4 months)
- Incidence of injury to physical therapist caused by device [PT safety](duration of study completion for each site, estimated 4 months)
Investigators
Study Sites (10)
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