Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT02118194
Status:
COMPLETED
Last Update Posted:
2025-05-11
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI
Sponsor:
James J. Peters Veterans Affairs Medical Center
Organization:
Study Overview
Official Title:
Assessment of Home/Work Simulation Tasks and Community Mobility Skills in the ReWalk Powered Exoskeleton in Persons With Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VA_ReWalk2
Brief Summary:
The overall goal of this project is to determine if non-ambulatory persons with spinal cord injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be further trained to achieve more advanced skills for use in the home or work place environments and outdoor community mobility skills in the ReWalk exoskeleton.
Detailed Description:
Evaluation criteria will consist of the level of assistance, number of sessions and time to perform each of the tasks. Because some of these tasks have never been performed in an exoskeleton there is no standardized information to set a goal. As such, level of assistance and time to complete those tasks will be recorded in each participant for a descriptive analysis. Other tests, such as the six-minute walk test (6mWT), 10 meter walk test (10mWT) and timed up and go (TUG) have a range of specific timed values that have been measured in the exoskeleton by our investigators and others. These exoskeletal-assisted walking tests have standardized criteria on which the participants will be evaluated.
Participants will attend three to four, one to two-hour sessions per week for a total of 20 sessions in six weeks. Each session will consist of exoskeletal-assisted skill practice during standing and walking mobility training. In order to determine the number of session to learn the tasks, measurements will be performed one time weekly for the task-specific skills and walking tests and again at the end of 20 sessions.
Participants will tested in the exoskeleton for ability to perform certain task-specific indoor and outdoor mobility skills.
Advanced indoor skills include, but are not limited to:
1. Performance on a an indoor six-minute walk test (6minWT) and ten meter walk test (10mWT) on a smooth floor and on carpet;
2. Timed up and go test (TUG) performance indoors on a smooth floor and on carpet;
3. Home/work skills include: manipulating items on a counter top, retrieving an item from an overhead cabinet, and/or retrieving an object from a refrigerator;
4. Door navigation skills include: a push button door, revolving door and/or a non-powered door;
5. Elevator Skills include: pressing the call button outside an elevator, navigate the elevator doors, pressing the floor selection buttons in an elevator, and/or exiting the elevator doors; and
6. Exoskeletal-assisted stair ascent and descent.
Advanced outdoor skills include, but are not limited to:
1. 10 mWT and 6minWT performance outdoors on concrete, asphalt, uneven surfaces, and grass.
2. Exoskeletal-assisted walking on incline slopes (assessed as time to navigate a specified distance) for: up slight slope, down slight slope, navigate up curb cut-out, and/or navigate down curb cut-out.
3. Ability to navigate up and/or down a curb (assessed as level of assistance required).
Note: Additional skills may be tested and recorded as per each individual's ability and competency.
Participants will attend three to four, one to two-hour sessions per week for a total of 20 sessions in six weeks. Each session will consist of exoskeletal-assisted skill practice during standing and walking mobility training. In order to determine the number of session to learn the tasks, measurements will be performed one time weekly for the task-specific skills and walking tests and again at the end of 20 sessions.
Participants will tested in the exoskeleton for ability to perform certain task-specific indoor and outdoor mobility skills.
Advanced indoor skills include, but are not limited to:
1. Performance on a an indoor six-minute walk test (6minWT) and ten meter walk test (10mWT) on a smooth floor and on carpet;
2. Timed up and go test (TUG) performance indoors on a smooth floor and on carpet;
3. Home/work skills include: manipulating items on a counter top, retrieving an item from an overhead cabinet, and/or retrieving an object from a refrigerator;
4. Door navigation skills include: a push button door, revolving door and/or a non-powered door;
5. Elevator Skills include: pressing the call button outside an elevator, navigate the elevator doors, pressing the floor selection buttons in an elevator, and/or exiting the elevator doors; and
6. Exoskeletal-assisted stair ascent and descent.
Advanced outdoor skills include, but are not limited to:
1. 10 mWT and 6minWT performance outdoors on concrete, asphalt, uneven surfaces, and grass.
2. Exoskeletal-assisted walking on incline slopes (assessed as time to navigate a specified distance) for: up slight slope, down slight slope, navigate up curb cut-out, and/or navigate down curb cut-out.
3. Ability to navigate up and/or down a curb (assessed as level of assistance required).
Note: Additional skills may be tested and recorded as per each individual's ability and competency.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: