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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03499210
• Other study ID #: CLN0011
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2018
• Source: ReWalk Robotics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiparesis
• Hemiplegia
• Paresis
• Stroke
• Stroke Hemorrhagic
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Institute	Boston	Massachusetts
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	Moss Rehab	Elkins Park	Pennsylvania
United States	TIRR Memorial Hermann	Houston	Texas
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (6)

Lead Sponsor	Collaborator
ReWalk Robotics, Inc.	Kessler Foundation, Moss Rehabilitation Research Institute, Shirley Ryan AbilityLab, Spaulding Rehabilitation Hospital, TIRR Memorial Hermann

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait speed measured with 10 Meter Walk Test	Subjects will perform a 10 Meter Walk Test to evaluate walking speed with and without the ReStore device.	duration of study participation for each subject, estimated 4 weeks
Other	Gait analysis using a gait mat	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.	duration of study participation for each subject, estimated 4 weeks
Other	Walking distance measured with 2 Minute Walk Test	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	duration of study participation for each subject, estimated 4 weeks
Other	Modified QUEST questionnaire [subject satisfaction]	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.	duration of study participation for each subject, estimated 4 weeks
Other	Physical Therapist satisfaction questionnaire [PT satisfaction]	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.	duration of study completion for each site, estimated 4 months
Primary	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	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.	duration of study completion for each site, estimated 4 months
Secondary	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.	duration of study completion for each site, estimated 4 months