Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI (VA_ReWalk2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT02118194
First received: March 28, 2014
Last updated: April 8, 2015
Last verified: April 2015
  Purpose
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.

Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Home/Work Simulation Tasks and Community Mobility Skills in the ReWalk Powered Exoskeleton in Persons With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females with paraplegia (T1 and below) who are unable to walk on their own will be eligible for participation in this study.
Criteria

Inclusion Criteria:

  • Males or females with spinal cord injury (SCI) who have already participated in at least 20 ReWalk training sessions.

Exclusion Criteria:

  1. Diagnosis of neurological injury other than SCI including: Multiple sclerosis (MS), Stroke, Cerebral Palsy (CP), Amyotrophic lateral sclerosis (ALS), Traumatic Brain injury (TBI), Spina bifida, Parkinson's disease (PD), or other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary;
  2. Severe concurrent medical disease, illness or condition;
  3. Unhealed fractures;
  4. Systemic or peripheral infection;
  5. Atherosclerosis, congestive heart failure, or history of myocardial infarction;
  6. Trunk and/or lower extremity pressure ulcers;
  7. Other illness, that the study physician considers in his/her clinical judgment to be exclusionary;
  8. Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist);
  9. Significant contractures or heterotropic ossification of the lower extremities that prevent flexion and extension of the joint;
  10. Distal femur and/or proximal tibia bone mineral density less than 0.59 cm2.
  11. Femoral neck or the total proximal femur bone mineral density T-scores < -3.5;
  12. Psychopathology documentation in the medical record or history of that may conflict with study objectives;
  13. Hypertension (Systolic Blood Pressure >140, Diastolic Blood Pressure >90); and/or
  14. Pregnancy and/or lactating females.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118194

Contacts
Contact: Pierre K Asselin, MSBioMedEng 718-584-9000 ext 3124 pierre.asselin@va.gov
Contact: Steven Knezevic, MSExerPhys 718-584-9000 ext 3130 steven.knezevic@va.gov

Locations
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    pierre.asselin@va.gov   
Contact: Steven Knezevic, MSExerPhys    718-584-9000 ext 3130    steven.knezevic@va.gov   
Principal Investigator: Ann M Spungen, EdD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Principal Investigator: Ann M Spungen, EdD James J Peters VA Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ann M. Spungen, EdD, Research Health Science Specialist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02118194     History of Changes
Other Study ID Numbers: JJPVAMC ReWalk2
Study First Received: March 28, 2014
Last Updated: April 8, 2015

Keywords provided by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center:
paraplegia
paralysis
robotics
walking
immobilization

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 25, 2017