Spinal Cord InjuryVA_ReWalk2NCT02118194
Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI
An observational study of Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Males or females with spinal cord injury (SCI) who have already participated in at least 20 ReWalk training sessions.
Who cannot join
- 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;
- Severe concurrent medical disease, illness or condition;
- Unhealed fractures;
- Systemic or peripheral infection;
- Atherosclerosis, congestive heart failure, or history of myocardial infarction;
- Trunk and/or lower extremity pressure ulcers;
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- Other illness, that the study physician considers in his/her clinical judgment to be exclusionary;
- Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist);
- Significant contractures or heterotropic ossification of the lower extremities that prevent flexion and extension of the joint;
- Distal femur and/or proximal tibia bone mineral density less than 0.59 cm2.
- Femoral neck or the total proximal femur bone mineral density T-scores < -3.5;
- Psychopathology documentation in the medical record or history of that may conflict with study objectives;
- Hypertension (Systolic Blood Pressure >140, Diastolic Blood Pressure >90); and/or
- Pregnancy and/or lactating females.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: Assessment of Home/Work Simulation Tasks and Community Mobility Skills in the ReWalk Powered Exoskeleton in Persons With Spinal Cord Injury
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.
Read the 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:
- 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.
- Conditions
- Spinal Cord Injury
- Keywords
- paraplegia, paralysis, robotics, walking, immobilization
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessments are weekly during the 20-session protocol and at the end over a 6 week period
Secondary outcomes (1)
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.
Measured: Assessments are weekly during the 20-session protocol and at the end over a 6 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startOct 2013
- Primary completion6 Oct 2022
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
- Investigators
- Ann M Spungen, EdD, Principal investigator, James J Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118194
- Sponsor's protocol ID
- JJPVAMC ReWalk2
- Acronym
- VA_ReWalk2
- Status last verified
- May 2025
- First submitted
- 28 Mar 2014
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26364279
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Home/Work Simulation Tasks and Community Mobility Skills in the ReWalk Powered Exoskeleton in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02118194
- Acronym / sponsor ID
- VA_ReWalk2 / JJPVAMC ReWalk2
- Conditions
- Spinal Cord Injury
- Keywords
- paraplegia, paralysis, robotics, walking, immobilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Oct 2013
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Males or females with spinal cord injury (SCI) who have already participated in at least 20 ReWalk training sessions.
Key exclusion criteria (14 listed)
- 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;
- Severe concurrent medical disease, illness or condition;
- Unhealed fractures;
- Systemic or peripheral infection;
- Atherosclerosis, congestive heart failure, or history of myocardial infarction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 26364279Yang 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.
- Spinal Cord Damage Research Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Spungen, EdD principal investigator
James J Peters VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.