C-Brace Prospective Registry
Purpose
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.
Conditions
- Pareses
- Lower Extremity
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Otto Bock Healthcare Products GmbH
Detailed 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.