C-Brace Prospective Registry

Otto Bock Healthcare (Ottobock)

Status: Enrolling

Conditions: Lower Extremity; Pareses

Treatments: Device: C-Brace

Study type: Observational

Funder types: Industry

Identifiers

NCT04640584

PD-PS00120018A-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.