Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03499210|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : June 19, 2018
|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)|
|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 :||August 31, 2018|
|Estimated Study Completion Date :||August 31, 2018|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499210
|Contact: Kathleen E O'Donnell, MID||508-251-1154 ext email@example.com|
|United States, Illinois|
|Shirley Ryan AbilityLab||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Matt Giffhorn, PT, DPT, NCS 312-238-2637 firstname.lastname@example.org|
|United States, Massachusetts|
|Spaulding Rehabilitation Institute||Recruiting|
|Boston, Massachusetts, United States, 02129|
|Contact: Reginia Sloutsky, DPT email@example.com|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Contact: Kate Goworek Chervin 973-324-3560 firstname.lastname@example.org|
|United States, Pennsylvania|
|Elkins Park, Pennsylvania, United States, 19027|
|Contact: Stella Lee, MPA 215-663-6665 LeeST@einstein.edu|
|United States, Texas|
|TIRR Memorial Hermann||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ruta Paranjape, MS, CCRP 713-799-6976 Ruta.Paranjape@uth.tmc.edu|