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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.
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:
Advanced outdoor skills include, but are not limited to:
Note: Additional skills may be tested and recorded as per each individual's ability and competency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions and level of assistance to achieve the advanced indoor and outdoor exoskeletal-assisted walking skills | 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. | Assessments are weekly during the 20-session protocol and at the end over a 6 week period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions and level of assistance to achieve specific advanced indoor standing and door navigation skills | 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. | Assessments are weekly during the 20-session protocol and at the end over a 6 week period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions and level of assistance to achieve exoskeletal-assisted stair ascent and descent | Participants will be timed to ascend and descend 13 steps in a stair well. | Assessments are weekly during the 20-session protocol an at the end over a 6 week period |
Inclusion Criteria:
Exclusion Criteria:
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Males and females with paraplegia (T1 and below) who are unable to walk on their own will be eligible for participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Ann M Spungen, EdD | James J Peters VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J Peters VA Medical Center | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364279 | Derived | Yang A, Asselin P, Knezevic S, Kornfeld S, Spungen AM. Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):100-9. doi: 10.1310/sci2102-100. Epub 2015 Apr 12. |
| Label | URL |
|---|---|
| Spinal Cord Damage Research Center website | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |