C-Brace Prospective Registry

NCT ID: NCT04640584

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pareses Lower Extremity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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C-Brace

The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.

Intervention Type DEVICE

Other Intervention Names

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Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otto Bock Healthcare Products GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Braatz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Private University of Applied Sciences

Locations

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Jonesboro P&O x Ottobock.care

Harrison, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Jonesboro P&O x Ottobock.care

Rogers, Arkansas, United States

Site Status TERMINATED

Bionics Orthotics & Prosthetics

San Diego, California, United States

Site Status RECRUITING

ABI P&O

San Diego, California, United States

Site Status COMPLETED

West Coast Brace & Limb - Palm Harbor

Palm Harbor, Florida, United States

Site Status RECRUITING

Hanger - Sarasota

Sarasota, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

West Coast Brace & Limb - Tampa

Tampa, Florida, United States

Site Status RECRUITING

ProCare Prosthetics x Ottobock.care

Buford, Georgia, United States

Site Status RECRUITING

ProCare x Ottobock.care

Conyers, Georgia, United States

Site Status RECRUITING

Scheck & Siress: A Hanger Clinic Company

Chicago, Illinois, United States

Site Status COMPLETED

P&O Care x Ottobock.care

Fairview Heights, Illinois, United States

Site Status RECRUITING

Kenney Orthopedics - Evansville

Evansville, Indiana, United States

Site Status COMPLETED

Prevail Prosthetics & Orthotics

Fort Wayne, Indiana, United States

Site Status COMPLETED

Bionic Prosthetics & Orthotics

Merrillville, Indiana, United States

Site Status RECRUITING

Kenney Orthopedics - Danville

Danville, Kentucky, United States

Site Status COMPLETED

Kenney Orthopedics - Lexington

Lexington, Kentucky, United States

Site Status WITHDRAWN

Ability x Ottobock.care

Frederick, Maryland, United States

Site Status RECRUITING

Dankmeyer

Linthicum, Maryland, United States

Site Status RECRUITING

Medical Center Orthotics & Prosthetics

Silver Spring, Maryland, United States

Site Status COMPLETED

Cornell Orthotics & Prosthetics

Beverly, Massachusetts, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Clinton Township, Michigan, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Farmington Hills, Michigan, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Flint, Michigan, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Lansing, Michigan, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Lapeer, Michigan, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Livonia, Michigan, United States

Site Status RECRUITING

Wright & Filippis x Ottobock.care

Madison Heights, Michigan, United States

Site Status RECRUITING

Limb Lab

Rochester, Minnesota, United States

Site Status RECRUITING

P&O Care x Ottobock.care

St Louis, Missouri, United States

Site Status RECRUITING

Limb Lab

Omaha, Nebraska, United States

Site Status RECRUITING

AlliedOP

Fair Lawn, New Jersey, United States

Site Status RECRUITING

AlliedOP

Mount Laurel, New Jersey, United States

Site Status RECRUITING

MedEast Post-op & Surgical

Mount Laurel, New Jersey, United States

Site Status COMPLETED

Body in Motion

Toms River, New Jersey, United States

Site Status RECRUITING

Raymond G. Murphy VA

Albuquerque, New Mexico, United States

Site Status TERMINATED

Orthocraft Inc. - 3856 Flatlands Ave

Brooklyn, New York, United States

Site Status RECRUITING

VA NY Harbor

Manhattan, New York, United States

Site Status COMPLETED

Prosthetics in Motion

New York, New York, United States

Site Status COMPLETED

Reliable P&O

Jacksonville, North Carolina, United States

Site Status COMPLETED

Bionic Prosthetics & Orthotics

Lenoir, North Carolina, United States

Site Status RECRUITING

O&P of Pinehurst

Pinehurst, North Carolina, United States

Site Status COMPLETED

Atlantic Prosthetic Services

Wilmington, North Carolina, United States

Site Status RECRUITING

Yanke Bionics - W Exchange St

Akron, Ohio, United States

Site Status COMPLETED

Western Reserve O&P

Austintown, Ohio, United States

Site Status COMPLETED

Ability P&O x Ottobock.care

Exton, Pennsylvania, United States

Site Status RECRUITING

Titleman Orthopedic

Philadelphia, Pennsylvania, United States

Site Status COMPLETED

elizur Corporation

Pittsburgh, Pennsylvania, United States

Site Status WITHDRAWN

Ability x Ottobock.care

Wyomissing, Pennsylvania, United States

Site Status RECRUITING

Ability x Ottobock.care

York, Pennsylvania, United States

Site Status RECRUITING

South County Artificial Limb and Brace

Wakefield, Rhode Island, United States

Site Status WITHDRAWN

Carolina Ottobock.care

Spartanburg, South Carolina, United States

Site Status RECRUITING

Excel P&O

Kingsport, Tennessee, United States

Site Status COMPLETED

Restorative Health Services

Murfreesboro, Tennessee, United States

Site Status COMPLETED

Ottobock.care

Austin, Texas, United States

Site Status RECRUITING

New Life

Conroe, Texas, United States

Site Status COMPLETED

Scott Sabolich Prosthetics & Research x Ottobock.care

Dallas, Texas, United States

Site Status RECRUITING

Baker O&P

Fort Worth, Texas, United States

Site Status RECRUITING

Hanger Clinic - Houston

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Michael E. DeBakey VA

Houston, Texas, United States

Site Status COMPLETED

TIRR Research Center

Houston, Texas, United States

Site Status COMPLETED

South Texas Veterans Health Care System

San Antonio, Texas, United States

Site Status TERMINATED

Freedom P & O - 356 E 600 S

St. George, Utah, United States

Site Status WITHDRAWN

Hunter Holmes McGuire VA

Richmond, Virginia, United States

Site Status COMPLETED

VA O&P

Roanoke, Virginia, United States

Site Status COMPLETED

Cornerstone P&O

Everett, Washington, United States

Site Status RECRUITING

Cascade Prosthetics & Orthotics

Ferndale, Washington, United States

Site Status RECRUITING

Hanger Clinic - Renton

Renton, Washington, United States

Site Status COMPLETED

Pacific Medical

Richland, Washington, United States

Site Status RECRUITING

Thompson's O&P

Spokane, Washington, United States

Site Status COMPLETED

Bionic Prosthetics & Orthotics

Green Bay, Wisconsin, United States

Site Status RECRUITING

Neuromuscular-orthotics.com.au

Clayton, Victoria, Australia

Site Status NOT_YET_RECRUITING

Pohlig BmbH

Traunstein, Bavaria, Germany

Site Status RECRUITING

Ottobock Göttingen

Göttingen, Deutschland, Germany

Site Status RECRUITING

John+Bamberg GmbH & Co. KG

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Katholisches Klinikum Koblenz-Montabaur

Koblenz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Hyogo Rehabilitation Hospital

Kobe, Hyōgo, Japan

Site Status RECRUITING

Countries

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United States Australia Germany Japan

Central Contacts

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Russell L Lundstrom, MS

Role: CONTACT

512-806-2606

Barbara Pobatschnig, MSc

Role: CONTACT

+43 1 5233786-720

Facility Contacts

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Emily Rau, MSPO, CPO

Role: primary

8582709972

Danielle Tobler

Role: primary

(727) 785-0100

Walt Raynor

Role: primary

(813) 985-4499

Theresa Field

Role: primary

(770) 271-5581

James Kling, CPO/L

Role: primary

(770) 271-5581

Dylan Borrenpohl, MS, CPO

Role: primary

(618) 212-0006

Daniel Chan, MBA, COA

Role: primary

(219) 791-9200

Curtis Kowalczyk, CO

Role: primary

(301) 698-4692

Angela Bryl

Role: primary

(410) 636-8114

Claire Hebert

Role: primary

9789222866

Natalie Karabelski, CO

Role: primary

(586) 468-8289

Robin Beals, BS, CPO

Role: primary

(248) 615-0041

Ken Steel, CO

Role: primary

(810) 234-6582

Daniel Durany, CO

Role: primary

(517) 484-2624

Francy Lemp, CPO

Role: primary

(810) 664-1101

Matthew Cinader, MSOP, CPO

Role: primary

(734) 421-8400

Mike Hoisington, BS, CO

Role: primary

(586) 804-6124

Andrew Nelson

Role: primary

507-322-3457

Luke Brewer

Role: primary

(314) 775-2041

Vincent Lau, MS, CPO

Role: primary

402-899-9110

Kristen Lindsay, MSPO, CPO

Role: primary

2017963121

Macy Oteri

Role: primary

856-273-6400

John Caputo

Role: primary

(732) 244-8700

Kayla Watts

Role: primary

(828) 758-0002

Bob Collins

Role: primary

(910) 350-0067

Thomas Martin

Role: primary

(800) 455-0058

Taffy Bowman, CPO

Role: primary

(610) 709-6459

Jonah Rhymer, MPO, CPO

Role: primary

(717) 851-0156

John Lundquist, BOCP, COF, CPed

Role: primary

(864) 541-0028

Travis Heins

Role: primary

(737) 707-0058

Edwin Hassler

Role: primary

(214) 382- 9270

Michael Serrano

Role: primary

(817) 332-7313

David Hughes

Role: primary

425.339.2559

Larry Paise, CPO

Role: primary

(360) 384-1858

Kevin Stoddard, CO, LO

Role: primary

(509) 371-9660

Chris Welch, MSPO, CPO

Role: primary

(920) 435-3002

Tia Wedge

Role: primary

+613 1300 411 666

Annabell Jahn

Role: primary

+49 861-7085-200

Heiko Drewitz

Role: primary

+49 5513075122

Sebastian Klug

Role: primary

Bärbel Heger

Role: primary

Takashi Oshima

Role: primary

000-000-0000

References

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Lundstrom RL, Klenow TD, Morris A, Pobatschnig B, Hibler KD, Kannenberg AH. The C-Brace(R) microprocessor controlled stance and swing orthosis improves safety, mobility, and quality of life at one year: Interim results from a prospective registry. J Rehabil Assist Technol Eng. 2024 Aug 9;11:20556683241269539. doi: 10.1177/20556683241269539. eCollection 2024 Jan-Dec.

Reference Type BACKGROUND
PMID: 39132469 (View on PubMed)

Other Identifiers

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PD-PS00120018A-001

Identifier Type: -

Identifier Source: org_study_id

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