C-Brace Prospective Registry

January 9, 2024 updated by: Otto Bock Healthcare Products GmbH

A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Not yet recruiting
        • Neuromuscular-orthotics.com.au
        • Contact:
        • Principal Investigator:
          • Sarah Anderson
  • Germany
    • Bavaria
      • Traunstein, Bavaria, Germany, 83278
        • Recruiting
        • Pohlig BmbH
        • Contact:
        • Principal Investigator:
          • Frank Braatz
    • Deutschland
      • Göttingen, Deutschland, Germany, 37075
        • Recruiting
        • Ottobock Göttingen
        • Principal Investigator:
          • Frank Braatz, Prof.
        • Contact:
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56073
        • Recruiting
        • Katholisches Klinikum Koblenz-Montabaur
        • Contact:
        • Principal Investigator:
          • Axel Rütz, MD
  • United States
    • California
      • San Diego, California, United States, 92120
        • Recruiting
        • ABI P&O
        • Contact:
        • Principal Investigator:
          • Herb Barrack
      • San Diego, California, United States, 92117
        • Recruiting
        • Bionics Orthotics & Prosthetics
        • Contact:
        • Principal Investigator:
          • Emily Rau, MSPO, CPO
    • Florida
      • Palm Harbor, Florida, United States, 34684
        • Recruiting
        • West Coast Brace & Limb - Palm Harbor
        • Contact:
        • Principal Investigator:
          • Bridget Lawler
      • Sarasota, Florida, United States, 34233
        • Active, not recruiting
        • Hanger - Sarasota
      • Tampa, Florida, United States, 33617
        • Recruiting
        • West Coast Brace & Limb - Tampa
        • Principal Investigator:
          • Bridget Lawler
        • Contact:
    • Georgia
      • Buford, Georgia, United States, 30518
        • Recruiting
        • ProCare Prosthetics x Ottobock.care
        • Contact:
        • Principal Investigator:
          • Gerald Stark, PhD
        • Sub-Investigator:
          • Theresa Field, MSPO, CPO
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Active, not recruiting
        • Scheck & Siress: A Hanger Clinic Company
      • Fairview Heights, Illinois, United States, 62208
        • Recruiting
        • P&O Care x Ottobock.care
        • Principal Investigator:
          • Gerald Stark, PhD
        • Contact:
        • Sub-Investigator:
          • Luke Brewer, BS, CPO
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Recruiting
        • Kenney Orthopedics - Evansville
        • Contact:
        • Principal Investigator:
          • Casey Thomas
        • Sub-Investigator:
          • Thomas Whitehurst
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Prevail Prosthetics & Orthotics
        • Contact:
        • Principal Investigator:
          • Kristoffer Kail
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • Bionic Prosthetics & Orthotics
        • Contact:
        • Principal Investigator:
          • Daniel Chan, MBA, COA
    • Kentucky
      • Danville, Kentucky, United States, 40422
        • Recruiting
        • Kenney Orthopedics - Danville
        • Principal Investigator:
          • Casey Thomas
        • Contact:
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Kenney Orthopedics - Lexington
        • Principal Investigator:
          • Casey Thomas
        • Contact:
        • Sub-Investigator:
          • Andy Moore
    • Maryland
      • Linthicum, Maryland, United States, 21090
        • Recruiting
        • Dankmeyer
        • Principal Investigator:
          • Angela Bryl
        • Contact:
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Medical Center Orthotics & Prosthetics
        • Principal Investigator:
          • Justin Boehm
        • Contact:
        • Principal Investigator:
          • Ian Fothergill
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Recruiting
        • Cornell Orthotics & Prosthetics
        • Contact:
        • Principal Investigator:
          • Claire Hebert, MSPO, CPO
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Wright & Filippis x Ottobock.care
        • Principal Investigator:
          • Gerald Stark, PhD
        • Contact:
        • Sub-Investigator:
          • Mike Hoisington, BS, CO
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Wright & Filippis x Ottobock.care
        • Principal Investigator:
          • Gerald Stark, PhD
        • Sub-Investigator:
          • Mike Hoisington, BS, CO
        • Contact:
      • Madison Heights, Michigan, United States, 48071
        • Recruiting
        • Wright & Filippis x Ottobock.care
        • Principal Investigator:
          • Gerald Stark, PhD
        • Sub-Investigator:
          • Mike Hoisington, BS, CO
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55904
        • Recruiting
        • Limb Lab
        • Contact:
        • Principal Investigator:
          • Andrew Nelson
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • P&O Care x Ottobock.care
        • Contact:
        • Principal Investigator:
          • Gerald Stark, PhD, CPO/L
        • Sub-Investigator:
          • Luke Brewer
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • Recruiting
        • AlliedOP
        • Contact:
        • Principal Investigator:
          • Kristen Lindsay, MSPO, CPO
      • Mount Laurel, New Jersey, United States, 08054
        • Recruiting
        • AlliedOP
        • Principal Investigator:
          • Kristen Lindsay, MSPO, CPO
        • Contact:
        • Sub-Investigator:
          • Macy Oteri, MSPO, CPO
      • Mount Laurel, New Jersey, United States, 08054
        • Recruiting
        • MedEast Post-op & Surgical
        • Contact:
        • Principal Investigator:
          • Matthew Graham
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Body in Motion
        • Contact:
          • John Caputo
          • Phone Number: 732-244-8700
        • Principal Investigator:
          • John Caputo
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Terminated
        • Raymond G. Murphy VA
    • New York
      • Brooklyn, New York, United States, 11234
        • Recruiting
        • Orthocraft Inc. - 3856 Flatlands Ave
        • Principal Investigator:
          • Herschel Sauber, CO, LPO
      • Manhattan, New York, United States, 10010
        • Completed
        • VA NY Harbor
      • New York, New York, United States, 10001
        • Completed
        • Prosthetics in Motion
    • North Carolina
      • Jacksonville, North Carolina, United States, 28546
        • Completed
        • Reliable P&O
      • Lenoir, North Carolina, United States, 28645
        • Recruiting
        • Bionic Prosthetics & Orthotics
        • Principal Investigator:
          • Daniel Chan, MBA, COA
        • Contact:
      • Pinehurst, North Carolina, United States, 28374
        • Completed
        • O&P of Pinehurst
      • Wilmington, North Carolina, United States, 28412
        • Recruiting
        • Atlantic Prosthetic Services
        • Contact:
        • Principal Investigator:
          • Bob Collins
    • Ohio
      • Akron, Ohio, United States, 44302
        • Recruiting
        • Yanke Bionics - W Exchange St
        • Contact:
        • Principal Investigator:
          • Greg Lalli, CPO
        • Sub-Investigator:
          • Jackie Hamblen, CPO
      • Austintown, Ohio, United States, 44515
        • Completed
        • Western Reserve O&P
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Recruiting
        • Ability P&O x Ottobock.care
        • Contact:
        • Principal Investigator:
          • Gerry Stark
        • Sub-Investigator:
          • Thomas Martin
      • Philadelphia, Pennsylvania, United States, 19083
        • Completed
        • Titleman Orthopedic
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • elizur Corporation
        • Contact:
        • Principal Investigator:
          • Aaron Calla
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • Ability P&O x Ottobock.care
        • Principal Investigator:
          • Gerald Stark, PhD
        • Contact:
    • Rhode Island
      • Wakefield, Rhode Island, United States, 02879
        • Withdrawn
        • South County Artificial Limb and Brace
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Completed
        • Excel P&O
      • Murfreesboro, Tennessee, United States, 37129
        • Completed
        • Restorative Health Services
    • Texas
      • Conroe, Texas, United States, 77384
        • Completed
        • New Life
      • Dallas, Texas, United States, 75148
        • Recruiting
        • Scott Sabolich Prosthetics & Research x Ottobock.care
        • Principal Investigator:
          • Gerald Stark, PhD
        • Contact:
        • Sub-Investigator:
          • Edwin Hassler
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Baker O&P
        • Principal Investigator:
          • Kenneth O'Meara
        • Contact:
        • Sub-Investigator:
          • Michael Serrano
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E. DeBakey VA
        • Contact:
        • Principal Investigator:
          • Mon Bryant
      • Houston, Texas, United States, 77025
        • Active, not recruiting
        • Hanger Clinic - Houston
      • Houston, Texas, United States, 77030
        • Completed
        • TIRR Research Center
      • San Antonio, Texas, United States, 78229
        • Terminated
        • South Texas Veterans Health Care System
    • Utah
      • Saint George, Utah, United States, 84770
        • Withdrawn
        • Freedom P & O - 356 E 600 S
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Completed
        • Hunter Holmes McGuire VA
      • Roanoke, Virginia, United States, 24012
        • Completed
        • VA O&P
    • Washington
      • Everett, Washington, United States, 98203
        • Recruiting
        • Cornerstone P&O
        • Contact:
        • Principal Investigator:
          • David Hughes
      • Renton, Washington, United States, 98057
        • Active, not recruiting
        • Hanger Clinic - Renton
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Thompson's O&P
        • Contact:
        • Principal Investigator:
          • Andrew Lind

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

As the purpose of the C-Brace Registry is to characterize safety and effectiveness data in a real-world setting, the inclusion and exclusion criteria are deliberately written as open as possible to allow all patients casted for a C-Brace fitting to be included as subjects in the registry. The indications and contraindications for the C-Brace are provided in the Instructions for Use and are based on clinical presentation, not on etiology. Clinical presentations will involve lower limb paresis that may be due to a variety of etiologies, including incomplete paraplegia, post-polio syndrome, peripheral neuropathy, traumatic brain injury and muscular sclerosis.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient is geographically inaccessible to comply and participate in the registry.
  • Patient has not been casted for a C-Brace fitting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy: Timed Walk Test
Time Frame: 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.
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
Primary Efficacy: Timed Up and Go (TUG) Test
Time Frame: 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.
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.
Primary Efficacy: Activities-specific Balance Confidence (ABC)
Time Frame: 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.
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.
Primary Safety: Frequency and severity of falling
Time Frame: 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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Specific Functional Scale (PSFS)
Time Frame: 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.
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.
Activity Tracker
Time Frame: 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.
Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker
Berg Balance Scale (BBS)
Time Frame: 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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Reduction in joint, lower back, and limb pain as measured by the NPRS compared to baseline when assessed 12 months after the initial fitting with C-Brace.
The NPRS is a valid and reliable measure of pain that may be used across all musculoskeletal injuries/conditions and complements the Patient Specific Functional Scale (PSFS). The patient will be asked to rate the pain of their joints, foot, lower back, and if they are using an assistive device any additional affected limbs on average over the last 24 hours on a scale 1-10, with '1' being 'very mild' and '10' being the 'unimaginable unspeakable'. There is no total score for the NPRS.
Reduction in joint, lower back, and limb pain as measured by the NPRS compared to baseline when assessed 12 months after the initial fitting with C-Brace.
Manual Muscle Test
Time Frame: Changes in muscle strength and function as measured by the Manual Muscle Test (MMT) compared to baseline when assessed 12 months after initial fitting.
The Manual Muscle Test is using a grading system of 0-5 in muscles of the lower body (hip, knee, ankle), 0 indicating none muscle strength at all, 5 means normal. In addition, assessments for range of motion, contractures, and alignment in the lower limb will all be recorded.There is no total score for these assessments
Changes in muscle strength and function as measured by the Manual Muscle Test (MMT) compared to baseline when assessed 12 months after initial fitting.
EQ-5D-5L
Time Frame: Changes in health-related quality of life as assessed by the EQ-5D-5L with the C-Brace system compared to baseline when assessed 12 months after the initial fitting.
Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. These weights, sometimes referred to as 'utilities', are often used to compute QALYs for use in health economic analyses. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Changes in health-related quality of life as assessed by the EQ-5D-5L with the C-Brace system compared to baseline when assessed 12 months after the initial fitting.
PROMIS Pain Interference - Short Form 6a
Time Frame: Reduction in the consequences of pain as measured by the PROMIS Pain Interference Short form 6a compared to baseline when assessed at 12 months after the initial fitting.
PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. For this registry the Pain Interference - Short Form 6a has been chosen for use by the patient. The patient will be asked six questions related to how pain may have interfered with certain activities in the last 7 days, and rate them on a 1-5 scale, with '1' being 'not at all' and '5' being 'very much.' To find the total raw score for the short form, the values of the responses are summed. The raw score is then converted to a T-Score. A higher PROMIS T-score represents more of the concept being measured.
Reduction in the consequences of pain as measured by the PROMIS Pain Interference Short form 6a compared to baseline when assessed at 12 months after the initial fitting.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto Bock Healthcare Products GmbH

Investigators

  • Principal Investigator: Frank Braatz, Prof., Private University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-PS00120018A-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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