Registry to evaluate the C-Brace System for lower extremity pareses
A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
Otto Bock Healthcare Products GmbH · NCT04640584
This study is testing how well the C-Brace System works for people with weak legs to see if it helps them move better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Otto Bock Healthcare Products GmbH (industry) |
| Locations | 76 sites (Harrison, Arkansas and 75 other locations) |
| Trial ID | NCT04640584 on ClinicalTrials.gov |
What this trial studies
The C-Brace Prospective Registry aims to collect safety and effectiveness data for the C-Brace System in patients with lower extremity pareses. Participants who have been fitted for the C-Brace will be enrolled and followed according to standard care protocols, which include baseline evaluations and follow-up assessments at 6, 12, 24, and 36 months. This observational study will gather both baseline and follow-up data to better understand the impact of the C-Brace on patient mobility and quality of life.
Who should consider this trial
Good fit: Ideal candidates are patients who have been evaluated, tested with the Trial Tool, and casted for a C-Brace fitting.
Not a fit: Patients who are geographically inaccessible or have not been casted for a C-Brace fitting may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of the C-Brace, potentially improving mobility and quality of life for patients with lower extremity pareses.
How similar studies have performed: While this registry approach is not novel, it builds on existing methodologies to evaluate assistive devices, and similar studies have shown success in gathering meaningful data on patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Harrison, Arkansas and 75 other locations
- Jonesboro P&O x Ottobock.care — Harrison, Arkansas, United States (ACTIVE_NOT_RECRUITING)
- Jonesboro P&O x Ottobock.care — Rogers, Arkansas, United States (TERMINATED)
- Bionics Orthotics & Prosthetics — San Diego, California, United States (RECRUITING)
- ABI P&O — San Diego, California, United States (COMPLETED)
- West Coast Brace & Limb - Palm Harbor — Palm Harbor, Florida, United States (RECRUITING)
- Hanger - Sarasota — Sarasota, Florida, United States (ACTIVE_NOT_RECRUITING)
- West Coast Brace & Limb - Tampa — Tampa, Florida, United States (RECRUITING)
- ProCare Prosthetics x Ottobock.care — Buford, Georgia, United States (RECRUITING)
- ProCare x Ottobock.care — Conyers, Georgia, United States (RECRUITING)
- Scheck & Siress: A Hanger Clinic Company — Chicago, Illinois, United States (COMPLETED)
- P&O Care x Ottobock.care — Fairview Heights, Illinois, United States (RECRUITING)
- Kenney Orthopedics - Evansville — Evansville, Indiana, United States (COMPLETED)
- Prevail Prosthetics & Orthotics — Fort Wayne, Indiana, United States (COMPLETED)
- Bionic Prosthetics & Orthotics — Merrillville, Indiana, United States (RECRUITING)
- Kenney Orthopedics - Danville — Danville, Kentucky, United States (COMPLETED)
- Kenney Orthopedics - Lexington — Lexington, Kentucky, United States (WITHDRAWN)
- Ability x Ottobock.care — Frederick, Maryland, United States (RECRUITING)
- Dankmeyer — Linthicum, Maryland, United States (RECRUITING)
- Medical Center Orthotics & Prosthetics — Silver Spring, Maryland, United States (COMPLETED)
- Cornell Orthotics & Prosthetics — Beverly, Massachusetts, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Clinton Township, Michigan, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Farmington Hills, Michigan, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Flint, Michigan, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Lansing, Michigan, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Lapeer, Michigan, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Livonia, Michigan, United States (RECRUITING)
- Wright & Filippis x Ottobock.care — Madison Heights, Michigan, United States (RECRUITING)
- Limb Lab — Rochester, Minnesota, United States (RECRUITING)
- P&O Care x Ottobock.care — St Louis, Missouri, United States (RECRUITING)
- Limb Lab — Omaha, Nebraska, United States (RECRUITING)
- AlliedOP — Fair Lawn, New Jersey, United States (RECRUITING)
- AlliedOP — Mount Laurel, New Jersey, United States (RECRUITING)
- MedEast Post-op & Surgical — Mount Laurel, New Jersey, United States (COMPLETED)
- Body in Motion — Toms River, New Jersey, United States (RECRUITING)
- Raymond G. Murphy VA — Albuquerque, New Mexico, United States (TERMINATED)
- Orthocraft Inc. - 3856 Flatlands Ave — Brooklyn, New York, United States (RECRUITING)
- VA NY Harbor — Manhattan, New York, United States (COMPLETED)
- Prosthetics in Motion — New York, New York, United States (COMPLETED)
- Reliable P&O — Jacksonville, North Carolina, United States (COMPLETED)
- Bionic Prosthetics & Orthotics — Lenoir, North Carolina, United States (RECRUITING)
- O&P of Pinehurst — Pinehurst, North Carolina, United States (COMPLETED)
- Atlantic Prosthetic Services — Wilmington, North Carolina, United States (RECRUITING)
- Yanke Bionics - W Exchange St — Akron, Ohio, United States (COMPLETED)
- Western Reserve O&P — Austintown, Ohio, United States (COMPLETED)
- Ability P&O x Ottobock.care — Exton, Pennsylvania, United States (RECRUITING)
- Titleman Orthopedic — Philadelphia, Pennsylvania, United States (COMPLETED)
- elizur Corporation — Pittsburgh, Pennsylvania, United States (WITHDRAWN)
- Ability x Ottobock.care — Wyomissing, Pennsylvania, United States (RECRUITING)
- Ability x Ottobock.care — York, Pennsylvania, United States (RECRUITING)
- South County Artificial Limb and Brace — Wakefield, Rhode Island, United States (WITHDRAWN)
+26 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Frank Braatz, Prof. — Private University of Applied Sciences
- Study coordinator: Russell L Lundstrom, MS
- Email: russ.lundstrom@ottobock.com
- Phone: 512-806-2606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pareses, Lower Extremity