Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke
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
1 other identifier
interventional
40
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2018
Shorter than P25 for not_applicable stroke
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedNovember 7, 2018
November 1, 2018
8 months
March 27, 2018
November 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Other Outcomes (5)
Gait speed measured with 10 Meter Walk Test
duration of study participation for each subject, estimated 4 weeks
Gait analysis using a gait mat
duration of study participation for each subject, estimated 4 weeks
Walking distance measured with 2 Minute Walk Test
duration of study participation for each subject, estimated 4 weeks
- +2 more other outcomes
Study Arms (1)
Investigational group
EXPERIMENTALAll subjects will participate in study procedures involving use of the ReWalk ReStore device.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ReWalk Robotics, Inc.lead
- Shirley Ryan AbilityLabcollaborator
- Kessler Foundationcollaborator
- TIRR Memorial Hermanncollaborator
- Spaulding Rehabilitation Hospitalcollaborator
- Moss Rehabilitation Research Institutecollaborator
Study Sites (5)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Spaulding Rehabilitation Institute
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
Related Publications (1)
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.
PMID: 32552775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 17, 2018
Study Start
March 29, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
November 7, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share