What is this study trying to find out about lower extremity pareses?

This study is gathering information on the safety and effectiveness of the C-Brace, a device designed to assist walking in people with lower extremity pareses. Researchers want to understand how the C-Brace affects walking speed, balance, and risk of falls. The study is sponsored by Otto Bock Healthcare Products GmbH and follows patients over several years.

Who may be eligible for this lower extremity pareses clinical trial?

Adults with lower extremity pareses who have been tested and casted for the C-Brace, can communicate and follow instructions, and are willing to provide consent may be eligible. There is no age or gender restriction. Patients must also be able to attend follow-up visits. Please review eligibility criteria for more details.

Is there any cost to participate in this lower extremity pareses clinical trial?

Study-related care, including the C-Brace device and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

All Genders

ID04640584

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

Led by Otto Bock Healthcare Products GmbH · Updated on 2025-04-30

250

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

CONDITIONS

Brief Title

C-Brace Prospective Registry

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

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.

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Baseline and fitting period

Participants are fitted with the C-Brace device, which includes individually fabricated components and a sensor system to assist walking.

1 baseline visit (in-person) and fitting session

Post-implementation Follow-up

Duration - 36 months after definitive fitting

Participants receive training and therapy sessions to use the C-Brace and are followed according to standard care with evaluations at multiple time points.

Follow-up visits at 6 months, 12 months, 24 months, and 36 months

Trial Site Locations

Total: 76 locations

Jonesboro P&O x Ottobock.care

Harrison, Arkansas, United States, 72601

Active, Not Recruiting

Jonesboro P&O x Ottobock.care

Rogers, Arkansas, United States, 72758

Terminated

Bionics Orthotics & Prosthetics

San Diego, California, United States, 92117

Actively Recruiting

ABI P&O

San Diego, California, United States, 92120

Completed

West Coast Brace & Limb - Palm Harbor

Palm Harbor, Florida, United States, 34684

Actively Recruiting

Hanger - Sarasota

Sarasota, Florida, United States, 34233

Active, Not Recruiting

West Coast Brace & Limb - Tampa

Tampa, Florida, United States, 33617

Actively Recruiting

ProCare Prosthetics x Ottobock.care

Buford, Georgia, United States, 30518

Actively Recruiting

ProCare x Ottobock.care

Conyers, Georgia, United States, 30094

Actively Recruiting

Scheck & Siress: A Hanger Clinic Company

Chicago, Illinois, United States, 60657

Completed

P&O Care x Ottobock.care

Fairview Heights, Illinois, United States, 62208

Actively Recruiting

Kenney Orthopedics - Evansville

Evansville, Indiana, United States, 47715

Completed

Prevail Prosthetics & Orthotics

Fort Wayne, Indiana, United States, 46804

Completed

Bionic Prosthetics & Orthotics

Merrillville, Indiana, United States, 46410

Actively Recruiting

Kenney Orthopedics - Danville

Danville, Kentucky, United States, 40422

Completed

Kenney Orthopedics - Lexington

Lexington, Kentucky, United States, 40503

Withdrawn

Ability x Ottobock.care

Frederick, Maryland, United States, 21702

Actively Recruiting

Dankmeyer

Linthicum, Maryland, United States, 21090

Actively Recruiting

Medical Center Orthotics & Prosthetics

Silver Spring, Maryland, United States, 20910

Completed

Cornell Orthotics & Prosthetics

Beverly, Massachusetts, United States, 01915

Actively Recruiting