Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

250

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach

4 countries

76 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 years study duration

Study Start

First participant enrolled

April 1, 2015

Completed

5.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

11 years

First QC Date

November 17, 2020

Last Update Submit

April 25, 2025

Conditions

Pareses Lower Extremity

Outcome Measures

Primary Outcomes (4)

Primary Efficacy: Timed Walk Test
The Timed Walk test is used to measure gait speed on either a 25-foot or 10-meter straight course timed using the middle 10 feet or 6 meters, respectively. Three trials are performed and the average of the three used. Patients are allowed the use of assistive device (such as a cane, crutches or walker) that they normally use for in home or community ambulation.
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
Originally designed to test mobility skills in the elderly, the TUG is a validated test for quantifying functional mobility and risk of falling. In the TUG Test, patients are asked to stand up from a chair, walk ten feet, turn and return to the chair, and then sit on the chair. For centers routinely using the TUG as a part of their standard of care, this data (time to complete in seconds) will be collected at baseline and follow-up visits when available. Predictive results from the test are as follows: \<10s, Freely mobile; \< 20s, Mostly independent; 20-29s, Variable mobility.
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)
Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
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
The number and percentage of patients who experience one or more adverse events during their participation in the registry will be computed along with the exact 95% binomial confidence interval. The number and percentage of subjects who experience a serious adverse event will also be tabulated along with the exact 95% binomial confidence interval. Events will also be categorized and the number of events and number of patients for each category will be presented. In addition, a complete listing of adverse events along with their relationship to the device, severity, seriousness and outcome will be constructed.
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

Secondary Outcomes (3)

Patient Specific Functional Scale (PSFS)
Changes in patient-centered activities and in the defined activity performance with C-Brace by the PSFS compared to baseline when assessed 12 months after the initial fitting.
Activity Tracker
Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker
Berg Balance Scale (BBS)
Changes in static and dynamic balance abilities as measured by the BBS compared to baseline when assessed 12 months after initial fitting with C-Brace.

Other Outcomes (4)

Numeric Pain Rating Scale (NPRS)
Reduction in joint, lower back, and limb pain as measured by the NPRS compared to baseline when assessed 12 months after the initial fitting with C-Brace.
Manual Muscle Test
Changes in muscle strength and function as measured by the Manual Muscle Test (MMT) compared to baseline when assessed 12 months after initial fitting.
EQ-5D-5L
Changes in health-related quality of life as assessed by the EQ-5D-5L with the C-Brace system compared to baseline when assessed 12 months after the initial fitting.
+1 more other outcomes

Interventions

C-BraceDEVICE

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.

Also known as: Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

As the purpose of the C-Brace Registry is to characterize safety and effectiveness data in a real-world setting, the inclusion and exclusion criteria are deliberately written as open as possible to allow all patients casted for a C-Brace fitting to be included as subjects in the registry. The indications and contraindications for the C-Brace are provided in the Instructions for Use and are based on clinical presentation, not on etiology. Clinical presentations will involve lower limb paresis that may be due to a variety of etiologies, including incomplete paraplegia, post-polio syndrome, peripheral neuropathy, traumatic brain injury and muscular sclerosis.

You may qualify if:

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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Otto Bock Healthcare Products GmbHlead

Study Sites (76)

Jonesboro P&O x Ottobock.care

Harrison, Arkansas, 72601, United States

ACTIVE NOT RECRUITING

Jonesboro P&O x Ottobock.care

Rogers, Arkansas, 72758, United States

TERMINATED

Bionics Orthotics & Prosthetics

San Diego, California, 92117, United States

RECRUITING

ABI P&O

San Diego, California, 92120, United States

COMPLETED

West Coast Brace & Limb - Palm Harbor

Palm Harbor, Florida, 34684, United States

RECRUITING

Hanger - Sarasota

Sarasota, Florida, 34233, United States

ACTIVE NOT RECRUITING

West Coast Brace & Limb - Tampa

Tampa, Florida, 33617, United States

RECRUITING

ProCare Prosthetics x Ottobock.care

Buford, Georgia, 30518, United States

RECRUITING

ProCare x Ottobock.care

Conyers, Georgia, 30094, United States

RECRUITING

Scheck & Siress: A Hanger Clinic Company

Chicago, Illinois, 60657, United States

COMPLETED

P&O Care x Ottobock.care

Fairview Heights, Illinois, 62208, United States

RECRUITING

Kenney Orthopedics - Evansville

Evansville, Indiana, 47715, United States

COMPLETED

Prevail Prosthetics & Orthotics

Fort Wayne, Indiana, 46804, United States

COMPLETED

Bionic Prosthetics & Orthotics

Merrillville, Indiana, 46410, United States

RECRUITING

Kenney Orthopedics - Danville

Danville, Kentucky, 40422, United States

COMPLETED

Kenney Orthopedics - Lexington

Lexington, Kentucky, 40503, United States

WITHDRAWN

Ability x Ottobock.care

Frederick, Maryland, 21702, United States

RECRUITING

Dankmeyer

Linthicum, Maryland, 21090, United States

RECRUITING

Medical Center Orthotics & Prosthetics

Silver Spring, Maryland, 20910, United States

COMPLETED

Cornell Orthotics & Prosthetics

Beverly, Massachusetts, 01915, United States

RECRUITING