search
Back to results

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

Primary Purpose

Stroke, Stroke, Acute, Stroke Hemorrhagic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReWalk ReStore device
Sponsored by
ReWalk Robotics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, Exoskeleton, Hemiparesis, Hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLab
  • Spaulding Rehabilitation Institute
  • Kessler Foundation
  • Moss Rehab
  • TIRR Memorial Hermann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational group

Arm Description

All subjects will participate in study procedures involving use of the ReWalk ReStore device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of device malfunctions during study procedures [Device Reliability]
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.
Incidence of injury to physical therapist caused by device [PT safety]
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.

Full Information

First Posted
March 27, 2018
Last Updated
November 6, 2018
Sponsor
ReWalk Robotics, Inc.
Collaborators
Shirley Ryan AbilityLab, Kessler Foundation, TIRR Memorial Hermann, Spaulding Rehabilitation Hospital, Moss Rehabilitation Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03499210
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReWalk Robotics, Inc.
Collaborators
Shirley Ryan AbilityLab, Kessler Foundation, TIRR Memorial Hermann, Spaulding Rehabilitation Hospital, Moss Rehabilitation Research Institute

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute, Stroke Hemorrhagic, Hemiparesis, Hemiplegia, Cerebrovascular Accident
Keywords
Stroke, Exoskeleton, Hemiparesis, Hemiplegia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational group
Arm Type
Experimental
Arm Description
All subjects will participate in study procedures involving use of the ReWalk ReStore device.
Intervention Type
Device
Intervention Name(s)
ReWalk ReStore device
Intervention Description
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 Measure Information:
Title
Incidence of device-related adverse events [Safety]
Description
Safety will be evaluated on the basis of the number of device-related adverse events reported for subjects during their participation in the study.
Time Frame
duration of study participation for each subject, estimated 4 weeks
Secondary Outcome Measure Information:
Title
Incidence of device malfunctions during study procedures [Device Reliability]
Description
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.
Time Frame
duration of study completion for each site, estimated 4 months
Title
Incidence of injury to physical therapist caused by device [PT safety]
Description
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.
Time Frame
duration of study completion for each site, estimated 4 months
Other Pre-specified Outcome Measures:
Title
Gait speed measured with 10 Meter Walk Test
Description
Subjects will perform a 10 Meter Walk Test to evaluate walking speed with and without the ReStore device.
Time Frame
duration of study participation for each subject, estimated 4 weeks
Title
Gait analysis using a gait mat
Description
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.
Time Frame
duration of study participation for each subject, estimated 4 weeks
Title
Walking distance measured with 2 Minute Walk Test
Description
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
Time Frame
duration of study participation for each subject, estimated 4 weeks
Title
Modified QUEST questionnaire [subject satisfaction]
Description
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.
Time Frame
duration of study participation for each subject, estimated 4 weeks
Title
Physical Therapist satisfaction questionnaire [PT satisfaction]
Description
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.
Time Frame
duration of study completion for each site, estimated 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Spaulding Rehabilitation Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Moss Rehab
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32552775
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs