Clinical trial NCT03499210: Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Stroke, Acute
Stroke Hemorrhagic
Hemiparesis
Hemiplegia
Cerebrovascular Accident
Keywords: Stroke
Exoskeleton
Hemiparesis
Hemiplegia
Lead sponsor: ReWalk Robotics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shirley Ryan AbilityLab
name: Kessler Foundation
name: TIRR Memorial Hermann
name: Spaulding Rehabilitation Hospital
name: Moss Rehabilitation Research Institute
First posted: 2018-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of device-related adverse events [Safety]
timeFrame: duration of study participation for each subject, estimated 4 weeks
Secondary outcomes:
measure: Incidence of device malfunctions during study procedures [Device Reliability]
timeFrame: duration of study completion for each site, estimated 4 months
measure: Incidence of injury to physical therapist caused by device [PT safety]
timeFrame: duration of study completion for each site, estimated 4 months
Other outcomes:
measure: Gait speed measured with 10 Meter Walk Test
timeFrame: duration of study participation for each subject, estimated 4 weeks
measure: Gait analysis using a gait mat
timeFrame: duration of study participation for each subject, estimated 4 weeks
measure: Walking distance measured with 2 Minute Walk Test
timeFrame: duration of study participation for each subject, estimated 4 weeks
measure: Modified QUEST questionnaire [subject satisfaction]
timeFrame: duration of study participation for each subject, estimated 4 weeks
measure: Physical Therapist satisfaction questionnaire [PT satisfaction]
timeFrame: duration of study completion for each site, estimated 4 months
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Boston
country: United States
facility: Spaulding Rehabilitation Institute
state: Massachusetts
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Elkins Park
country: United States
facility: Moss Rehab
state: Pennsylvania
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
References:
citation: 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.