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Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke

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ClinicalTrials.gov Identifier: NCT03499210
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Shirley Ryan AbilityLab
Kessler Foundation
TIRR Memorial Hermann
Spaulding Rehabilitation Hospital
Moss Rehabilitation Research Institute
Information provided by (Responsible Party):
ReWalk Robotics, Inc.

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.

Condition or disease Intervention/treatment Phase
Stroke Stroke, Acute Stroke Hemorrhagic Hemiparesis Hemiplegia Cerebrovascular Accident Device: ReWalk ReStore device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational group
All subjects will participate in study procedures involving use of the ReWalk ReStore device.
Device: ReWalk ReStore 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of device malfunctions during study procedures [Device Reliability] [ Time Frame: duration of study completion for each site, estimated 4 months ]
    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.

  2. Incidence of injury to physical therapist caused by device [PT safety] [ Time Frame: duration of study completion for each site, estimated 4 months ]
    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.


Other Outcome Measures:
  1. Gait speed measured with 10 Meter Walk Test [ Time Frame: duration of study participation for each subject, estimated 4 weeks ]
    Subjects will perform a 10 Meter Walk Test to evaluate walking speed with and without the ReStore device.

  2. Gait analysis using a gait mat [ Time Frame: duration of study participation for each subject, estimated 4 weeks ]
    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.

  3. Walking distance measured with 2 Minute Walk Test [ Time Frame: duration of study participation for each subject, estimated 4 weeks ]
    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

  4. Modified QUEST questionnaire [subject satisfaction] [ Time Frame: duration of study participation for each subject, estimated 4 weeks ]
    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.

  5. Physical Therapist satisfaction questionnaire [PT satisfaction] [ Time Frame: duration of study completion for each site, estimated 4 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499210


Locations
United States, Illinois
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
United States, Massachusetts
Spaulding Rehabilitation Institute
Boston, Massachusetts, United States, 02129
United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
United States, Pennsylvania
Moss Rehab
Elkins Park, Pennsylvania, United States, 19027
United States, Texas
TIRR Memorial Hermann
Houston, Texas, United States, 77030
Sponsors and Collaborators
ReWalk Robotics, Inc.
Shirley Ryan AbilityLab
Kessler Foundation
TIRR Memorial Hermann
Spaulding Rehabilitation Hospital
Moss Rehabilitation Research Institute

Responsible Party: ReWalk Robotics, Inc.
ClinicalTrials.gov Identifier: NCT03499210     History of Changes
Other Study ID Numbers: CLN0011
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by ReWalk Robotics, Inc.:
Stroke
Exoskeleton
Hemiparesis
Hemiplegia

Additional relevant MeSH terms:
Stroke
Paresis
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Paralysis