Clinical trial NCT04640584: C-Brace Prospective Registry
Official title: A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pareses
Lower Extremity
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

Brief summary: 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.

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.

Primary outcomes:
measure: Primary Efficacy: Timed Walk Test
timeFrame: 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
measure: Primary Efficacy: Timed Up and Go (TUG) Test
timeFrame: 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.
measure: Primary Efficacy: Activities-specific Balance Confidence (ABC)
timeFrame: 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.
measure: Primary Safety: Frequency and severity of falling
timeFrame: 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:
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 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.
measure: Activity Tracker
timeFrame: Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker
measure: Berg Balance Scale (BBS)
timeFrame: 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:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 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.
measure: Manual Muscle Test
timeFrame: Changes in muscle strength and function as measured by the Manual Muscle Test (MMT) compared to baseline when assessed 12 months after initial fitting.
measure: EQ-5D-5L
timeFrame: 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.
measure: PROMIS Pain Interference - Short Form 6a
timeFrame: Reduction in the consequences of pain as measured by the PROMIS Pain Interference Short form 6a compared to baseline when assessed at 12 months after the initial fitting.
Locations:
city: Harrison
country: United States
facility: Jonesboro P&O x Ottobock.care
state: Arkansas
city: Rogers
country: United States
facility: Jonesboro P&O x Ottobock.care
state: Arkansas
city: San Diego
country: United States
facility: Bionics Orthotics & Prosthetics
state: California
city: San Diego
country: United States
facility: ABI P&O
state: California
city: Palm Harbor
country: United States
facility: West Coast Brace & Limb - Palm Harbor
state: Florida
city: Sarasota
country: United States
facility: Hanger - Sarasota
state: Florida
city: Tampa
country: United States
facility: West Coast Brace & Limb - Tampa
state: Florida
city: Buford
country: United States
facility: ProCare Prosthetics x Ottobock.care
state: Georgia
city: Conyers
country: United States
facility: ProCare x Ottobock.care
state: Georgia
city: Chicago
country: United States
facility: Scheck & Siress: A Hanger Clinic Company
state: Illinois
city: Fairview Heights
country: United States
facility: P&O Care x Ottobock.care
state: Illinois
city: Evansville
country: United States
facility: Kenney Orthopedics - Evansville
state: Indiana
city: Fort Wayne
country: United States
facility: Prevail Prosthetics & Orthotics
state: Indiana
city: Merrillville
country: United States
facility: Bionic Prosthetics & Orthotics
state: Indiana
city: Danville
country: United States
facility: Kenney Orthopedics - Danville
state: Kentucky
city: Lexington
country: United States
facility: Kenney Orthopedics - Lexington
state: Kentucky
city: Frederick
country: United States
facility: Ability x Ottobock.care
state: Maryland
city: Linthicum
country: United States
facility: Dankmeyer
state: Maryland
city: Silver Spring
country: United States
facility: Medical Center Orthotics & Prosthetics
state: Maryland
city: Beverly
country: United States
facility: Cornell Orthotics & Prosthetics
state: Massachusetts
city: Clinton Township
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Farmington Hills
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Flint
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Lansing
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Lapeer
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Livonia
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Madison Heights
country: United States
facility: Wright & Filippis x Ottobock.care
state: Michigan
city: Rochester
country: United States
facility: Limb Lab
state: Minnesota
city: Saint Louis
country: United States
facility: P&O Care x Ottobock.care
state: Missouri
city: Omaha
country: United States
facility: Limb Lab
state: Nebraska
city: Fair Lawn
country: United States
facility: AlliedOP
state: New Jersey
city: Mount Laurel
country: United States
facility: AlliedOP
state: New Jersey
city: Mount Laurel
country: United States
facility: MedEast Post-op & Surgical
state: New Jersey
city: Toms River
country: United States
facility: Body in Motion
state: New Jersey
city: Alburquerque
country: United States
facility: Raymond G. Murphy VA
state: New Mexico
city: Brooklyn
country: United States
facility: Orthocraft Inc. - 3856 Flatlands Ave
state: New York
city: Manhattan
country: United States
facility: VA NY Harbor
state: New York
city: New York
country: United States
facility: Prosthetics in Motion
state: New York
city: Jacksonville
country: United States
facility: Reliable P&O
state: North Carolina
city: Lenoir
country: United States
facility: Bionic Prosthetics & Orthotics
state: North Carolina
city: Pinehurst
country: United States
facility: O&P of Pinehurst
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Prosthetic Services
state: North Carolina
city: Akron
country: United States
facility: Yanke Bionics - W Exchange St
state: Ohio
city: Austintown
country: United States
facility: Western Reserve O&P
state: Ohio
city: Exton
country: United States
facility: Ability P&O x Ottobock.care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Titleman Orthopedic
state: Pennsylvania
city: Pittsburg
country: United States
facility: elizur Corporation
state: Pennsylvania
city: Wyomissing
country: United States
facility: Ability x Ottobock.care
state: Pennsylvania
city: York
country: United States
facility: Ability x Ottobock.care
state: Pennsylvania
city: Wakefield
country: United States
facility: South County Artificial Limb and Brace
state: Rhode Island
city: Spartanburg
country: United States
facility: Carolina Ottobock.care
state: South Carolina
city: Kingsport
country: United States
facility: Excel P&O
state: Tennessee
city: Murfreesboro
country: United States
facility: Restorative Health Services
state: Tennessee
city: Austin
country: United States
facility: Ottobock.care
state: Texas
city: Conroe
country: United States
facility: New Life
state: Texas
city: Dallas
country: United States
facility: Scott Sabolich Prosthetics & Research x Ottobock.care
state: Texas
city: Fort Worth
country: United States
facility: Baker O&P
state: Texas
city: Houston
country: United States
facility: Hanger Clinic - Houston
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA
state: Texas
city: Houston
country: United States
facility: TIRR Research Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
city: Saint George
country: United States
facility: Freedom P & O - 356 E 600 S
state: Utah
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA
state: Virginia
city: Roanoke
country: United States
facility: VA O&P
state: Virginia
city: Everett
country: United States
facility: Cornerstone P&O
state: Washington
city: Ferndale
country: United States
facility: Cascade Prosthetics & Orthotics
state: Washington
city: Renton
country: United States
facility: Hanger Clinic - Renton
state: Washington
city: Richland
country: United States
facility: Pacific Medical
state: Washington
city: Spokane
country: United States
facility: Thompson's O&P
state: Washington
city: Green Bay
country: United States
facility: Bionic Prosthetics & Orthotics
state: Wisconsin
city: Clayton
country: Australia
facility: Neuromuscular-orthotics.com.au
state: Victoria
city: Traunstein
country: Germany
facility: Pohlig BmbH
state: Bavaria
city: Göttingen
country: Germany
facility: Ottobock Göttingen
state: Deutschland
city: Hanover
country: Germany
facility: John+Bamberg GmbH & Co. KG
state: Lower Saxony
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz-Montabaur
state: Rhineland-Palatinate
city: Kobe
country: Japan
facility: Hyogo Rehabilitation Hospital
state: Hyogo
Study officials:
affiliation: Private University of Applied Sciences
name: Frank Braatz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.