C-Brace Prospective Registry
- Conditions
- ParesesLower Extremity
- Registration Number
- NCT04640584
- Lead Sponsor
- Otto Bock Healthcare Products GmbH
- Brief Summary
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.
- Detailed Description
The purpose of the C-Brace Prospective Registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace. Patients casted for C-Brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. All patients will be followed in accordance with the standard of care for a C-Brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the C-Brace.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Patient has been evaluated and successfully tested with the Trial Tool, and has been casted for a C-Brace.
- Patient is able to communicate, provide feedback, understand and follow instructions during the course of the registry.
- Patient is willing to provide informed consent.
- Patient is geographically inaccessible to comply and participate in the registry.
- Patient has not been casted for a C-Brace fitting.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy: Activities-specific Balance Confidence (ABC) Changes in perceived balance confidence as assessed by the ABC score with the C-Brace system compared to baseline when assessed 12 months after the initial fitting. Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
Primary Safety: Frequency and severity of falling Changes in numbers of device-related adverse events experienced by C Brace users by frequency and severity compared to baseline measurement when assessed 12 months after the initial fitting The number and percentage of patients who experience one or more adverse events during their participation in the registry will be computed along with the exact 95% binomial confidence interval. The number and percentage of subjects who experience a serious adverse event will also be tabulated along with the exact 95% binomial confidence interval. Events will also be categorized and the number of events and number of patients for each category will be presented. In addition, a complete listing of adverse events along with their relationship to the device, severity, seriousness and outcome will be constructed.
Primary Efficacy: Timed Walk Test Change in walking speed with the C-Brace measured either by a 25-ft or 10-m walk test compared to baseline measurements when assessed 12 months after initial fitting The Timed Walk test is used to measure gait speed on either a 25-foot or 10-meter straight course timed using the middle 10 feet or 6 meters, respectively. Three trials are performed and the average of the three used. Patients are allowed the use of assistive device (such as a cane, crutches or walker) that they normally use for in home or community ambulation.
Primary Efficacy: Timed Up and Go (TUG) Test Changes in mobility, balance, risk of falling, and walking ability as measured by TUG test with the C-Brace system compared to baseline when assessed 12 months after the initial fitting. Originally designed to test mobility skills in the elderly, the TUG is a validated test for quantifying functional mobility and risk of falling. In the TUG Test, patients are asked to stand up from a chair, walk ten feet, turn and return to the chair, and then sit on the chair. For centers routinely using the TUG as a part of their standard of care, this data (time to complete in seconds) will be collected at baseline and follow-up visits when available. Predictive results from the test are as follows: \<10s, Freely mobile; \< 20s, Mostly independent; 20-29s, Variable mobility.
- Secondary Outcome Measures
Name Time Method Patient Specific Functional Scale (PSFS) Changes in patient-centered activities and in the defined activity performance with C-Brace by the PSFS compared to baseline when assessed 12 months after the initial fitting. The PSFS is a self-report measure aimed at identifying functional status limitations that are most relevant to individual patients.The PSFS is a reliable, valid, and efficient measure for detecting clinical change in persons with low back pain and knee dysfunction. Patients will be asked to identify three to five activities that they are having difficulty or are unable to perform because of their injury/condition. For the specified activities, patients will then be asked to rate their ability to perform each activity at that time (0-10 numerical scale) with '0' being unable to perform the activity, and '10' being able to perform the activity at the same level as they could prior to the injury/condition. There is no total score for this measure.
Activity Tracker Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker On the day the patient is casted for the C-Brace the patient's current orthosis will be affixed with an activity monitor to record the number of steps the patient takes with the orthosis. The patient will be sent home with a prepaid envelope and be instructed to mail back the activity monitor 16 days later, in order to capture 14 whole days of step count data. The step counts will be downloaded from the device the day the activity monitor is returned to the Investigator. The C-Brace will also be affixed with the same activity monitor following the same process for when the activity monitor was attached to the previous orthosis.
Berg Balance Scale (BBS) Changes in static and dynamic balance abilities as measured by the BBS compared to baseline when assessed 12 months after initial fitting with C-Brace. The BBS is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner. The points reached in each item were summed up to the total score.
Trial Locations
- Locations (62)
Pacific Medical
🇺🇸Richland, Washington, United States
Thompson's O&P
🇺🇸Spokane, Washington, United States
Jonesboro P&O x Ottobock.care
🇺🇸Rogers, Arkansas, United States
Bionics Orthotics & Prosthetics
🇺🇸San Diego, California, United States
ABI P&O
🇺🇸San Diego, California, United States
West Coast Brace & Limb - Palm Harbor
🇺🇸Palm Harbor, Florida, United States
Hanger - Sarasota
🇺🇸Sarasota, Florida, United States
West Coast Brace & Limb - Tampa
🇺🇸Tampa, Florida, United States
ProCare Prosthetics x Ottobock.care
🇺🇸Buford, Georgia, United States
ProCare x Ottobock.care
🇺🇸Conyers, Georgia, United States
Scheck & Siress: A Hanger Clinic Company
🇺🇸Chicago, Illinois, United States
P&O Care x Ottobock.care
🇺🇸Saint Louis, Missouri, United States
Kenney Orthopedics - Evansville
🇺🇸Evansville, Indiana, United States
Prevail Prosthetics & Orthotics
🇺🇸Fort Wayne, Indiana, United States
Bionic Prosthetics & Orthotics
🇺🇸Green Bay, Wisconsin, United States
Kenney Orthopedics - Danville
🇺🇸Danville, Kentucky, United States
Kenney Orthopedics - Lexington
🇺🇸Lexington, Kentucky, United States
Ability x Ottobock.care
🇺🇸York, Pennsylvania, United States
Dankmeyer
🇺🇸Linthicum, Maryland, United States
Medical Center Orthotics & Prosthetics
🇺🇸Silver Spring, Maryland, United States
Cornell Orthotics & Prosthetics
🇺🇸Beverly, Massachusetts, United States
Wright & Filippis x Ottobock.care
🇺🇸Madison Heights, Michigan, United States
Limb Lab
🇺🇸Omaha, Nebraska, United States
AlliedOP
🇺🇸Mount Laurel, New Jersey, United States
MedEast Post-op & Surgical
🇺🇸Mount Laurel, New Jersey, United States
Body in Motion
🇺🇸Toms River, New Jersey, United States
Raymond G. Murphy VA
🇺🇸Alburquerque, New Mexico, United States
Orthocraft Inc. - 3856 Flatlands Ave
🇺🇸Brooklyn, New York, United States
VA NY Harbor
🇺🇸Manhattan, New York, United States
Prosthetics in Motion
🇺🇸New York, New York, United States
Reliable P&O
🇺🇸Jacksonville, North Carolina, United States
O&P of Pinehurst
🇺🇸Pinehurst, North Carolina, United States
Atlantic Prosthetic Services
🇺🇸Wilmington, North Carolina, United States
Yanke Bionics - W Exchange St
🇺🇸Akron, Ohio, United States
Western Reserve O&P
🇺🇸Austintown, Ohio, United States
Ability P&O x Ottobock.care
🇺🇸Exton, Pennsylvania, United States
Titleman Orthopedic
🇺🇸Philadelphia, Pennsylvania, United States
elizur Corporation
🇺🇸Pittsburg, Pennsylvania, United States
South County Artificial Limb and Brace
🇺🇸Wakefield, Rhode Island, United States
Carolina Ottobock.care
🇺🇸Spartanburg, South Carolina, United States
Excel P&O
🇺🇸Kingsport, Tennessee, United States
Restorative Health Services
🇺🇸Murfreesboro, Tennessee, United States
Ottobock.care
🇺🇸Austin, Texas, United States
New Life
🇺🇸Conroe, Texas, United States
Scott Sabolich Prosthetics & Research x Ottobock.care
🇺🇸Dallas, Texas, United States
Baker O&P
🇺🇸Fort Worth, Texas, United States
Hanger Clinic - Houston
🇺🇸Houston, Texas, United States
Michael E. DeBakey VA
🇺🇸Houston, Texas, United States
TIRR Research Center
🇺🇸Houston, Texas, United States
South Texas Veterans Health Care System
🇺🇸San Antonio, Texas, United States
Freedom P & O - 356 E 600 S
🇺🇸Saint George, Utah, United States
Hunter Holmes McGuire VA
🇺🇸Richmond, Virginia, United States
VA O&P
🇺🇸Roanoke, Virginia, United States
Cornerstone P&O
🇺🇸Everett, Washington, United States
Cascade Prosthetics & Orthotics
🇺🇸Ferndale, Washington, United States
Hanger Clinic - Renton
🇺🇸Renton, Washington, United States
Neuromuscular-orthotics.com.au
🇦🇺Clayton, Victoria, Australia
Pohlig BmbH
🇩🇪Traunstein, Bavaria, Germany
Ottobock Göttingen
🇩🇪Göttingen, Deutschland, Germany
John+Bamberg GmbH & Co. KG
🇩🇪Hanover, Lower Saxony, Germany
Katholisches Klinikum Koblenz-Montabaur
🇩🇪Koblenz, Rhineland-Palatinate, Germany
Hyogo Rehabilitation Hospital
🇯🇵Kobe, Hyogo, Japan