|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS140001 / PSS002 |
| Date Original Plan Accepted |
03/09/2020
|
| Study Name |
ReWalk RWE Study
|
| Device Name |
Rewalk
|
| Root Document Number |
K131798
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
Other Data Source
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Long-term, non-interventional, non-randomized, observational study.
Two study arms: (1) Worldwide SalesForce CRM Database,
(2) Questionnaire. Questionnaire includes: Subjects, their Companions, and their Clinician Trainers.
|
| Study Population |
(1) SalesForce CRM Database: All worldwide users of the ReWalk device
(2) Questionaire: All US current and previous device owners (i.e., subjects), their companion(s), and their clinician trainer(s)
|
| Sample Size |
(1) SalesForce CRM Database: All worldwide users of the ReWalk device
(2) Questionaire: All US current and previous device owners (i.e., subjects), their companion(s), and their clinician trainer(s)
|
| Key Study Endpoints |
• Long-term safety of the ReWalk Device for subjects in institutional and non-institutional environments, as measured by all adverse events reported to ReWalk Robotics
• Long-term safety of the ReWalk Device for subjects in institutional and non-institutional environments, as measured by the incidence of falls and fall- assocaited injuries reported through the questionnaire(s) and database
• Long-term safety of the ReWalk Device for companions in institutional and non-institutional environments, as measured by all adverse events reported to ReWalk Robotics
• Adequacy and success rate of the training program of the ReWalk Device for subjects and companions, as measured by the database, training records, and questionnaires.
• Adequacy of the training program of the ReWalk device for subjects and companions as measured by the subjects’ proficiency in using device as documented in the questionnaires and step tracking data.
• Reliability of the ReWalk Device, as measured by the incidences of all device malfunctions
• Incidnece of unexpected adverse events
|
| Follow-up Visits and Length of Follow-up |
The study is an “all comers” registry study, using worldwide data from the ReWalk Robotics SalesForce CRM Database. The questionnaire arm cohort will be recruited from all US based subjects who had or continue to own a device, their companion(s), and their clinician trainer(s). ReWalk will perform a second round of recruitment through letters to all subjects, companions, and trainers who do not respond to the first request to participate.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Prospective Study - 12
Questionnaire - 57 users, 34 companions, 20 trainers (trained 28 users/companions)
Quality Management System - 569 (cumulative), no companion data
|
| Actual Number of Sites Enrolled |
Prospective Study - 2
Questionnaire - US
Quality Management System - OUS and US
|
| Patient Followup Rate |
Prospective Study - 5 completed Basic and Advanced training, 3 completed 12-month follow up (25%)
Questionnaire - 6 months to 6 years of use (100%)
Quality Management System - 6 months to 6 years of use (100%)
|
| Final Safety Findings |
Prospective Study: 1 (non-device related) serious adverse events out of 13 total adverse events; 4 out of 12 adverse events were device-related, 3 of which happened during training and 1 in the community - No falls
Questionnaire: 3 serious adverse events occurred to users and 1 occurred to a companion out of a total of a total of 26 adverse events; 7% of users had a non-fall related adverse event during training, 3.5% during first 12 months (F12M), 0% after that; 5.3% of users had a fall during training, 1.8% during F12M, 8.7% during past 12 months (P12M), 0% during last 3 months (L3M); 118% of companions had an adverse event during P12M only; 10.7% of trainers had adverse events during training (N=28 for number of training scenarios)
32 unique falls: 43.8% occurred during training, 12.5% during F12M, 37.5% during P12M, and 6.3% during L3M (50% of which were companion N=1, otherwise no companion falls); No deaths, 2.2% had major injuries (1 companion), 28.3% had minor injuries (9 users, 4 companions), and 69.6% had no injuries (21 users, 11 companions); 38% of falls were institutional, 62% non-institutional
Quality Management System: 34 serious adverse events to users and 1 to companion occurred over the entire course, rate of 1.0% and 0.5% respectively (when using device exposures each year as denominator); adverse event rates to users/companions as follows: 0.5% and 0% during trial, 2.8% and 0.5% during training, 0.4% and 0% during F12M, 0.2% and 0% during P12M, and 0% for both during L3M; new front knee bracket and changes in training materials with associated reduction in AEs and SAEs
50 unique falls: 62% during training, 22% during F12M, 14% during P12M, 2% during L3M; No deaths, 4% resulted in major injuries, 2% in moderate injuries, 64% no injuries, 30% unknown; 60% of falls were institutional, 36% non-institutional, 4% unknown
|
| Final Effectiveness Findings |
Prospective Study: No device malfunctions
41% of 12 enrolled participants completed basic and advanced training
Of the 5 who completed training, 3 used it in the community; steps/year ranged 6426-30689; therapists determined the users/companions had maintained their skills and improved at 12 months
Of the 5 users and their 5 companions, there was 1 report each of a medical complication at 1 month but did not use the device outside, no other medical complications noted during routine or 12 month appointments; From the 60 weekly reports from the 3 users they used the device in various environments excluding church, office, meeting room, or commercial, used the device on all surfaces (Granite lowest at 3.3%) and all terrains (driveway lowest at 13.3%)
Questionnaire: No malfunction data obtained
100% of users and 91.2% of companions completed basic training, 93% of users completed advanced training with 4% still in training and 94.1% of companions completed and 2.9% were still in training (unclear how 2 companions completed/were completing advanced without completing basic training); trainers said that 92.9% of those they trained completed advanced training with 3.6% still in training; reasons for not completing training: COVID-19, fractures (device related and unrelated), companion trained by a family member, user/companion insisted on taking device home despite not having completed training
87.7% used the device in the community, 80% of whom still used the device at the time of the questionnaire and 84$ used the device for more than 12 months; at least 90% of community users felt proficient in most basic and advanced skills (lowest reported proficiency was 74% and 82% respectively); 4% thought they walked slower, 16% through they walked shorter distances; 47 devices during F12M steps/year ranged 3603-289100 average 57013; 30 devices in P12M steps/year ranged 895-316551, avg 58063
Of 50 community users, they used it in all environments (lowest was meeting room 12%), all surfaces (lowest was granite at 48%), and all terrains (lowest was “other” 22%)
Quality Management System: Most common malfunctions are hardware and mechanical; percent of installed devices with malfunctions/year spiked in 2016 (~83% rate for hardware, 90% for mechanical), but declined to ~9% hardware, ~11% mechanical, ~2% software, and 0% for logistic, misuse, subcontractor, training, and usability
No training data
No surface/environment data
|
| Study Strengths and Weaknesses |
Prospective Study: Did not reach goal site/participant enrollment
Questionnaire: Risk of selection and recall bias; Able to get data from users, companions, and trainers
Quality Management System: Only obtained user and device-related data; Less risk of selection and recall bias
|
| Recommendations for Labeling Changes |
Update device labeling to include “falls” as a potential adverse event
|
|
