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 range18 Years
SexALL
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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
What they're measuring
1
Incidence of device-related adverse events [Safety]
Timeframe: duration of study participation for each subject, estimated 4 weeks