C-Brace Prospective Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-Brace.
- Who it may be relevant to
- Registry conditions: Pareses, Lower Extremity. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Germany, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
Overview
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.
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.
Interventions
- Device 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 measures
- 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]
Secondary outcome measures (3)
- Patient Specific Functional Scale (PSFS) [Time frame: 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 [Time frame: Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker]
- Berg Balance Scale (BBS) [Time frame: 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 70 centers
- Jonesboro P&O x Ottobock.care — Harrison
- Jonesboro P&O x Ottobock.care — Rogers
- Bionics Orthotics & Prosthetics — San Diego
- ABI P&O — San Diego
- West Coast Brace & Limb - Palm Harbor — Palm Harbor
- Hanger - Sarasota — Sarasota
- West Coast Brace & Limb - Tampa — Tampa
- ProCare Prosthetics x Ottobock.care — Buford
- … and 62 more centers
Germany · 4 centers
- Pohlig BmbH — Traunstein
- Ottobock Göttingen — Göttingen
- John+Bamberg GmbH & Co. KG — Hanover
- Katholisches Klinikum Koblenz-Montabaur — Koblenz
Australia · 1 center
- Neuromuscular-orthotics.com.au — Clayton
Japan · 1 center
- Hyogo Rehabilitation Hospital — Kobe
Publications
- Lundstrom RL, Klenow TD, Morris A, Pobatschnig B, Hibler KD, Kannenberg AH. The C-Brace(R) microprocessor controlled stance and swing orthosis improves safety, mobility, and quality of life at one year: Interim results from a prospective registry. J Rehabil Assist Technol Eng. 2024 Aug 9;11:20556683241269539. doi: 10.1177/20556683241269539. eCollection 2024 Jan-Dec. PMID 39132469
Identifiers
NCT: NCT04640584 · PD-PS00120018A-001