Recruiting

Observational Study

Sponsor:

Otto Bock Healthcare Products GmbH

Code:

NCT04640584

Conditions

Pareses

Lower Extremity

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

C-Brace

Study Details

Brief summary:

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

Conditions

Pareses

Lower Extremity

Study ID

NCT04640584

Start date

Apr, 2015

Status verified date

Apr, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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. ]
  • 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. ]
  • 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 ]

Central Contacts and Locations

Central contacts

Russell L Lundstrom, MS

512-806-2606russ.lundstrom@ottobock.com

Barbara Pobatschnig, MSc

+43 1 5233786-720barbara.pobatschnig@ottobock.com

Locations

Bionics Orthotics & Prosthetics

Recruiting

San Diego, California, United States, 92117

Contacts

Emily Rau, MSPO, CPO

8582709972erau@bionicsoandp.com

Principal Investigator:

Emily Rau, MSPO, CPO

West Coast Brace & Limb - Palm Harbor

Recruiting

Palm Harbor, Florida, United States, 34684

Contacts

Danielle Tobler

(727) 785-0100danielle.tobler@wcbl.com

Principal Investigator:

Bridget Lawler

West Coast Brace & Limb - Tampa

Recruiting

Tampa, Florida, United States, 33617

Contacts

Walt Raynor

(813) 985-4499walt.raynor@wcbl.com

Principal Investigator:

Bridget Lawler

ProCare Prosthetics x Ottobock.care

Recruiting

Buford, Georgia, United States, 30518

Contacts

Theresa Field

(770) 271-5581tfieldr@procarepando.com

Principal Investigator:

Roger "Eric" Shoemaker, CPO

ProCare x Ottobock.care

Recruiting

Conyers, Georgia, United States, 30094

Contacts

James Kling, CPO/L

(770) 271-5581jkling@procarepando.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

P&O Care x Ottobock.care

Recruiting

Fairview Heights, Illinois, United States, 62208

Contacts

Dylan Borrenpohl, MS, CPO

(618) 212-0006dylan.borrenpohl@ottobock.com

Principal Investigator:

Roger "Eric" Shoemaker, CPO

Bionic Prosthetics & Orthotics

Recruiting

Merrillville, Indiana, United States, 46410

Contacts

Daniel Chan, MBA, COA

(219) 791-9200danielchan@bionicpo.com

Principal Investigator:

Daniel Chan, MBA, COA

Ability x Ottobock.care

Recruiting

Frederick, Maryland, United States, 21702

Contacts

Curtis Kowalczyk, CO

(301) 698-4692curtis.kowalczyk@ottobock.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Dankmeyer

Recruiting

Linthicum, Maryland, United States, 21090

Contacts

Angela Bryl

(410) 636-8114abryl@dankmeyer.com

Principal Investigator:

Angela Bryl

Cornell Orthotics & Prosthetics

Recruiting

Beverly, Massachusetts, United States, 01915

Contacts

Claire Hebert

9789222866claire@cornelloandp.com

Principal Investigator:

Claire Hebert, MSPO, CPO

Wright & Filippis x Ottobock.care

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Natalie Karabelski, CO

(586) 468-8289natalie.k@wright-filippis.com

Principal Investigator:

Roger "Eric" Shoemaker, CPO

Wright & Filippis x Ottobock.care

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Robin Beals, BS, CPO

(248) 615-0041robin.b@wright-filippis.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Wright & Filippis x Ottobock.care

Recruiting

Flint, Michigan, United States, 48504

Contacts

Ken Steel, CO

(810) 234-6582ken.s@wright-filippis.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Wright & Filippis x Ottobock.care

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Daniel Durany, CO

(517) 484-2624dadurany@wright-filippis.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Wright & Filippis x Ottobock.care

Recruiting

Lapeer, Michigan, United States, 48446

Contacts

Francy Lemp, CPO

(810) 664-1101fmlemp@wright-filippis.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Wright & Filippis x Ottobock.care

Recruiting

Livonia, Michigan, United States, 48150

Contacts

Matthew Cinader, MSOP, CPO

(734) 421-8400

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Wright & Filippis x Ottobock.care

Recruiting

Madison Heights, Michigan, United States, 48071

Contacts

Mike Hoisington, BS, CO

(586) 804-6124mike.h@wright-filippis.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Limb Lab

Recruiting

Rochester, Minnesota, United States, 55904

Contacts

Andrew Nelson

507-322-3457andrew@limblab.com

Principal Investigator:

Andrew Nelson

P&O Care x Ottobock.care

Recruiting

Saint Louis, Missouri, United States, 63131

Contacts

Luke Brewer

(314) 775-2041luke.brewer@ottobock.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Limb Lab

Recruiting

Omaha, Nebraska, United States, 68106

Contacts

Vincent Lau, MS, CPO

402-899-9110

Principal Investigator:

Andrew Nelson, MS, CPO

AlliedOP

Recruiting

Fair Lawn, New Jersey, United States, 07410

Contacts

Kristen Lindsay, MSPO, CPO

2017963121klindsay@alliedop.com

Principal Investigator:

Kristen Lindsay, MSPO, CPO

AlliedOP

Recruiting

Mount Laurel, New Jersey, United States, 08054

Contacts

Macy Oteri

856-273-6400moteri@alliedop.com

Principal Investigator:

Kristen Lindsay, MSPO, CPO

Body in Motion

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

John Caputo

(732) 244-8700

Principal Investigator:

John Caputo

Orthocraft Inc. - 3856 Flatlands Ave

Recruiting

Brooklyn, New York, United States, 11234

Principal Investigator:

Herschel Sauber, CO, LPO

Bionic Prosthetics & Orthotics

Recruiting

Lenoir, North Carolina, United States, 28645

Contacts

Kayla Watts

(828) 758-0002lenoir@bionicpo.com

Principal Investigator:

Daniel Chan, MBA, COA

Atlantic Prosthetic Services

Recruiting

Wilmington, North Carolina, United States, 28412

Contacts

Bob Collins

(910) 350-0067bob@apswilm.com

Principal Investigator:

Bob Collins

Ability P&O x Ottobock.care

Recruiting

Exton, Pennsylvania, United States, 19341

Contacts

Thomas Martin

(800) 455-0058thomas.martin@ottobock.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Ability x Ottobock.care

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

Taffy Bowman, CPO

(610) 709-6459taffy.bowman@ottobock.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Ability x Ottobock.care

Recruiting

York, Pennsylvania, United States, 17401

Contacts

Jonah Rhymer, MPO, CPO

(717) 851-0156jonah.rhymer@abilitypo.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Carolina Ottobock.care

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

John Lundquist, BOCP, COF, CPed

(864) 541-0028jlundquist@carolinaop.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Ottobock.care

Recruiting

Austin, Texas, United States, 78758

Contacts

Travis Heins

(737) 707-0058travis.heins@ottobock.com

Principal Investigator:

Roger "Eric" Shoemaker, MS, CPO

Scott Sabolich Prosthetics & Research x Ottobock.care

Recruiting

Dallas, Texas, United States, 75148

Contacts

Edwin Hassler

(214) 382- 9270edwin.hassler@scottsabolich.com

Principal Investigator:

Gerald Stark, PhD

Baker O&P

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Michael Serrano

(817) 332-7313michael.serrano@bakerops.net

Principal Investigator:

Michael Serrano, CO

Cornerstone P&O

Recruiting

Everett, Washington, United States, 98203

Contacts

David Hughes

425.339.2559dhughes@cornerstonepo.com

Principal Investigator:

David Hughes

Cascade Prosthetics & Orthotics

Recruiting

Ferndale, Washington, United States, 98248

Contacts

Larry Paise, CPO

(360) 384-1858LarryP@Dafo.com

Principal Investigator:

Larry Paise, CPO

Pacific Medical

Recruiting

Richland, Washington, United States, 99352

Contacts

Kevin Stoddard, CO, LO

(509) 371-9660kstoddard@pacmedical.com

Principal Investigator:

Riley Liddell, MS, LCPO

Bionic Prosthetics & Orthotics

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Chris Welch, MSPO, CPO

(920) 435-3002cwelch@bionicpo.com

Principal Investigator:

Daniel Chan, MBA, COA

More Information

Sponsor

Otto Bock Healthcare Products GmbH

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Otto Bock Healthcare Products GmbH on 2025-04-30.