Injuries, Spinal CordNCT02944669
ReWalk Personal Device Postmarket Study
An observational study of Injuries, Spinal Cord, run by ReWalk Robotics, Inc. at 3 sites in United States.
Trial summary
This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injuries, Spinal Cord
- What is being tested?
- ReWalk Personal Device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with spinal cord injury at levels T7 to L5 and a prescription for the device.
Who may be able to join
- For use in institutional and non-institutional environments: Subjects with spinal cord injury at levels T7 to L5.
- Age ≥ 18 years old;
- Hands and shoulders can support crutches or a walker;
- Healthy bone density;
- Skeleton does not suffer from any fractures;
- Able to stand using a device such as EasyStand;
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- In general good health;
- Height is between 160 cm and 190 cm (5'3" - 6'2");
- Weight does not exceed 100 kg (220 lbs);
- Proficiency in spoken and written English language.
Who cannot join
- History of severe neurological injuries or disease other than SCI (MS, CP, ALS, TBI, etc.);
- Severe concurrent medical disease, including infections, circulatory, heart or lung, pressure sores;
- Severe spasticity (Ashworth 4)
- Uncontrolled clonus;
- Unstable spine or unhealed limbs or pelvic fractures;
- Heterotopic ossification;
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- Significant contractures;
- Psychiatric or cognitive situations that may interfere with proper operation of the device or participation in this study;
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
Elena Gillespie, PhD, 317-329-2212, elena.gillespie@rhin.com
James Malec, PhD, 317-329-2352, jim.malec@rhin.com
- Recruiting
Stanford University
Palo Alto, California, 94304
Ma Agnes Ith, 650-721-7600, mith@stanford.edu
Mathew Smuck, MD
- Recruiting
Casa Colina Hospital
Pomona, California, 91767
Stephanie Kaplan, DPT, 909-596-7733 ext. 4126, skaplan@casacolina.org
Emily Rosario, PhD, 909-596-7733 ext. 3036, erosario@casacolina.org
About this study
Official title: Long-Term, Prospective, Non-Interventional Study Monitoring Safety and Training in Patients With Spinal Cord Injuries and Their Trained Companions Recently Initiated With the ReWalk™ Personal Device
This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.
Read the detailed description
This study will monitor and further describe the long-term safety of the ReWalk Personal Device for Subjects and their Companions in institutional and non-institutional environments, such as the clinic, home, and community. The study will also evaluate the adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, their Companions, and their Clinical Trainers, monitor and further describe all ReWalk Personal Device malfunctions and screen for potential Unexpected Adverse Events.
- Conditions
- Injuries, Spinal Cord
- Being tested
- ReWalk Personal Device
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReWalk Personal DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Subjects
Measured: 12 Months
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of falls and fall- associated injuries
Measured: 12 Months
Long-term safety of the ReWalk Personal Device for Companions in institutional and non-institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Companions
Measured: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects enrolled in training who successfully complete the intended training
Measured: 12 Months
Adequacy of the ReWalk Training Program for Subjects, measured by the proportion of Subjects who successfully completed the intended training who are able to demonstrate proficiencies at 12 months after completion of the intended training
Measured: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the Subjects' abilities to navigate surfaces and environments outside of the institutional environment in accordance with their training
Measured: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the proportion of Companions enrolled in training who successfully complete the intended training
Measured: 12 Months
Secondary outcomes (4)
Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions
Measured: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning
Measured: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning
Measured: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Clinical Trainers, as measured by the qualitative Clinical Trainer responses to directed and open-ended questioning
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, Spinal CordStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReWalk Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew Smuck, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944669
- Sponsor's protocol ID
- RW-401
- Status last verified
- Feb 2017
- First submitted
- 24 Oct 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD will be made available after the 3-, 6-, and 12-month intervals.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term, Prospective, Non-Interventional Study Monitoring Safety and Training in Patients With Spinal Cord Injuries and Their Trained Companions Recently Initiated With the ReWalk™ Personal Device
- ClinicalTrials.gov ID
- NCT02944669
- Acronym / sponsor ID
- RW-401
- Conditions
- Injuries, Spinal Cord
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ReWalk Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 26 Oct 2016 (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.
This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.
Detailed description
This study will monitor and further describe the long-term safety of the ReWalk Personal Device for Subjects and their Companions in institutional and non-institutional environments, such as the clinic, home, and community. The study will also evaluate the adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, their Companions, and their Clinical Trainers, monitor and further describe all ReWalk Personal Device malfunctions and screen for potential Unexpected Adverse Events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with spinal cord injury at levels T7 to L5 and a prescription for the device.
Key inclusion criteria (10 listed)
- For use in institutional and non-institutional environments: Subjects with spinal cord injury at levels T7 to L5.
- Age ≥ 18 years old;
- Hands and shoulders can support crutches or a walker;
- Healthy bone density;
- Skeleton does not suffer from any fractures;
Key exclusion criteria (9 listed)
- History of severe neurological injuries or disease other than SCI (MS, CP, ALS, TBI, etc.);
- Severe concurrent medical disease, including infections, circulatory, heart or lung, pressure sores;
- Severe spasticity (Ashworth 4)
- Uncontrolled clonus;
- Unstable spine or unhealed limbs or pelvic fractures;
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 |
|---|---|---|
| ReWalk Personal Device | Device | – |
Primary outcome
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Subjects
Time frame: 12 Months
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of falls and fall- associated injuries
Time frame: 12 Months
Long-term safety of the ReWalk Personal Device for Companions in institutional and non-institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Companions
Time frame: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects enrolled in training who successfully complete the intended training
Time frame: 12 Months
Adequacy of the ReWalk Training Program for Subjects, measured by the proportion of Subjects who successfully completed the intended training who are able to demonstrate proficiencies at 12 months after completion of the intended training
Time frame: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the Subjects' abilities to navigate surfaces and environments outside of the institutional environment in accordance with their training
Time frame: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the proportion of Companions enrolled in training who successfully complete the intended training
Time frame: 12 Months
4 secondary outcomes
Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions
Time frame: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning
Time frame: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning
Time frame: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Clinical Trainers, as measured by the qualitative Clinical Trainer responses to directed and open-ended questioning
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Individual participant dataSharing planned: Yes. De-identified IPD will be made available after the 3-, 6-, and 12-month intervals.
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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.
Mathew Smuck, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries, Spinal Cord, run by ReWalk Robotics, Inc. at 3 sites 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Frazier, MS (508-281-7272, justin.frazier@rewalk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Subjects (time frame: 12 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2017.