ParaplegiaVA_ReWalkNCT01454570
The ReWalk Exoskeletal Walking System for Persons With Paraplegia
A study testing powered exoskeleton in people with Paraplegia, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paraplegia
- What is being tested?
- powered exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to 8 Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Males or females with paraplegia
- Duration of SCI >6 months
- Ages 18 to 65 y
- Height 160 to 190cm (63-75in or 5'3" to 6'3")
- Weight <100kg (<220 lb)
- Ability to give informed consent
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)
Show all 23Show fewer
- Spina bifida
- Parkinson's disease (PD)
- Other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary
- Severe concurrent medical disease, illness or condition
- Recent lower extremity fracture within the past 2 years;
- DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2
- Systemic or peripheral infection
- Atherosclerosis, congestive heart failure, or history of myocardial infarction
- Trunk and/or lower extremity pressure ulcers;
- 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 defined as flexion contracture limited to 35º at the hip and 20º at the knee;
- Diagnosis of heterotrophic ossification of the lower extremities;
- Femoral neck or the total proximal femur bone mineral density T-scores < -3.0
- Psychopathology documentation in the medical record or history of that may conflict with study objectives
- Hypertension (SBP>140, DBP>90)
- Pregnancy and/or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.
The Bronx, New York, 10468
About this study
It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury.
Read the detailed description
Potential participants will be pre-screened with the inclusion criteria for eligibility. The informed consent process will begin for those participants who have been determined to meet the inclusion criteria. After the potential participant's signed consent has been provided, further evaluations for eligibility will be performed (e.g., there are several medical and physical exclusion criteria). Those potential participants who meet both the inclusion and exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations and personalized measurements for fitting to the ReWalk-I will be performed over one week, before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12 sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by each participant's ReWalk learning curve. Training will begin with sit-to-stand, stand-to-sit, and standing balance activities. Progression to walking will occur as skills advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated after the Learning Phase, after the Training Phase and 1-month post training follow-up.
- Conditions
- Paraplegia
- Being tested
- powered exoskeleton
- Keywords
- exoskeleton walking system, paraplegia, paralysis
- Medical subject headings
- Paraplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powered exoskeletonDevice
| Study group | Role | What they receive |
|---|---|---|
| Powered Exoskeleton | Experimental | persons with SCI trained to use a powered exoskeleton to ambulate overground Receives: Device: powered exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count to Achieve Mobility Skills
- To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance:
- Sit-to-stand,
- Stand-to-sit,
- Standing balance for 1 minutes with both crutches,
- Standing balance for 30 seconds with one crutch,
- Ten meter walk in ≤2 minutes,
- Walk ≥30 meters in 6-minutes, and
- Ascend, turn around and descend 4 stairs in 5 minutes.
Measured: ReWalk training at 4 and 12 weeks, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completion8 Aug 2015
- Study completion8 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ParaplegiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 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, Bronx JJPVAMC CoE 7A-13
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454570
- Sponsor's protocol ID
- JJPVAMC: SPU-09-11
- Other IDs
- Protocol#: SPU-09-11
- Acronym
- VA_ReWalk
- Status last verified
- Aug 2020
- First submitted
- 14 Sep 2011
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tsai CY, Asselin PK, Hong E, Knezevic S, Kornfeld SD, Harel NY, Spungen AM. Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2021 Mar 12;7(1):20. doi: 10.1038/s41394-021-00384-8.
PubMed 33712561Asselin P, Cirnigliaro CM, Kornfeld S, Knezevic S, Lackow R, Elliott M, Bauman WA, Spungen AM. Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Feb;102(2):196-202. doi: 10.1016/j.apmr.2020.07.018. Epub 2020 Nov 7.
PubMed 33171129Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060.
PubMed 26230182
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ReWalk Exoskeletal Walking System for Persons With Paraplegia
- ClinicalTrials.gov ID
- NCT01454570
- Acronym / sponsor ID
- VA_ReWalk / JJPVAMC: SPU-09-11
- Conditions
- Paraplegia
- Keywords
- exoskeleton walking system, paraplegia, paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Feb 2011
- Primary completion
- 8 Aug 2015 (actual)
- Study completion
- 8 Aug 2015 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury.
Detailed description
Potential participants will be pre-screened with the inclusion criteria for eligibility. The informed consent process will begin for those participants who have been determined to meet the inclusion criteria. After the potential participant's signed consent has been provided, further evaluations for eligibility will be performed (e.g., there are several medical and physical exclusion criteria). Those potential participants who meet both the inclusion and exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations and personalized measurements for fitting to the ReWalk-I will be performed over one week, before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12 sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by each participant's ReWalk learning curve. Training will begin with sit-to-stand, stand-to-sit, and standing balance activities. Progression to walking will occur as skills advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated after the Learning Phase, after the Training Phase and 1-month post training follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Powered Exoskeleton | Experimental | Device: powered exoskeletonpersons with SCI trained to use a powered exoskeleton to ambulate overground |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females with paraplegia
- Duration of SCI >6 months
- Ages 18 to 65 y
- Height 160 to 190cm (63-75in or 5'3" to 6'3")
- Weight <100kg (<220 lb)
Key exclusion criteria (23 listed)
- Diagnosis of neurological injury other than SCI including:
- Severe concurrent medical disease, illness or condition
- Recent lower extremity fracture within the past 2 years;
- DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2
- Systemic or peripheral infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| powered exoskeleton | Device | Powered Exoskeleton |
Primary outcome
Count to Achieve Mobility Skills
Time frame: ReWalk training at 4 and 12 weeks, and 1-month follow-up
1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: 1. Sit-to-stand, 2. Stand-to-sit, 3. Standing balance for 1 minutes with both crutches, 4. Standing balance for 30 seconds with one crutch, 5. Ten meter walk in ≤2 minutes, 6. Walk ≥30 meters in 6-minutes, and 7. Ascend, turn around and descend 4 stairs in 5 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33712561Tsai CY, Asselin PK, Hong E, Knezevic S, Kornfeld SD, Harel NY, Spungen AM. Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2021 Mar 12;7(1):20. doi: 10.1038/s41394-021-00384-8.
- Derived from this study: PubMed 33171129Asselin P, Cirnigliaro CM, Kornfeld S, Knezevic S, Lackow R, Elliott M, Bauman WA, Spungen AM. Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Feb;102(2):196-202. doi: 10.1016/j.apmr.2020.07.018. Epub 2020 Nov 7.
- Derived from this study: PubMed 26230182Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060.
- A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit (RW)Link 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
Bronx JJPVAMC CoE 7A-13
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing powered exoskeleton in people with Paraplegia, 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 6 inclusion and 23 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 25 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count to Achieve Mobility Skills (time frame: ReWalk training at 4 and 12 weeks, and 1-month follow-up). 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 NCT01454570, which also lists 3 linked publications.
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 25 Aug 2020.