Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI (VA_ReWalk2)
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|ClinicalTrials.gov Identifier: NCT02118194|
Recruitment Status : Unknown
Verified April 2015 by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center.
Recruitment status was: Recruiting
First Posted : April 21, 2014
Last Update Posted : April 10, 2015
|Condition or disease|
|Spinal Cord Injury|
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:
- Performance on a an indoor six-minute walk test (6minWT) and ten meter walk test (10mWT) on a smooth floor and on carpet;
- Timed up and go test (TUG) performance indoors on a smooth floor and on carpet;
- 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;
- Door navigation skills include: a push button door, revolving door and/or a non-powered door;
- 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
- Exoskeletal-assisted stair ascent and descent.
Advanced outdoor skills include, but are not limited to:
- 10 mWT and 6minWT performance outdoors on concrete, asphalt, uneven surfaces, and grass.
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Assessment of Home/Work Simulation Tasks and Community Mobility Skills in the ReWalk Powered Exoskeleton in Persons With Spinal Cord Injury|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2017|
Paraplegia, spinal cord injury
An exoskeleton-assisted walking system for people with paralysis from spinal cord injury at thoracic level 1 and below (paraplegia) will be used.
- Number of sessions and level of assistance to achieve the advanced indoor and outdoor exoskeletal-assisted walking skills [ Time Frame: Assessments are weekly during the 20-session protocol and at the end over a 6 week period ]The walking tests (10mWT, 6-minWT, TUG) will be performed indoors on tile/linoleum and carpet and outdoors on concrete, asphalt, grass, dirt, uneven surfaces, curbs, curb cutouts, and ramps.
- Number of sessions and level of assistance to achieve specific advanced indoor standing and door navigation skills [ Time Frame: Assessments are weekly during the 20-session protocol and at the end over a 6 week period ]The advanced indoor standing skills include counter top work, retrieving of items from an overhead cabinet and from a refrigerator. The door navigation skills include a push button door, elevator doors, revolving doors, and non-powered doors.
- Number of sessions and level of assistance to achieve exoskeletal-assisted stair ascent and descent [ Time Frame: Assessments are weekly during the 20-session protocol an at the end over a 6 week period ]Participants will be timed to ascend and descend 13 steps in a stair well.
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): NCT02118194
|Contact: Pierre K Asselin, MSBioMedEng||718-584-9000 ext email@example.com|
|Contact: Steven Knezevic, MSExerPhys||718-584-9000 ext firstname.lastname@example.org|
|United States, New York|
|James J Peters VA Medical Center||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: Pierre K. Asselin, MSBioMed Eng 718-584-9000 ext 3124 email@example.com|
|Contact: Steven Knezevic, MSExerPhys 718-584-9000 ext 3130 firstname.lastname@example.org|
|Principal Investigator: Ann M Spungen, EdD|
|Principal Investigator:||Ann M Spungen, EdD||James J Peters VA Medical Center|