ParesesNCT04640584
C-Brace Prospective Registry
An observational study of Pareses and Lower Extremity, run by Otto Bock Healthcare Products GmbH at 76 sites in 4 countries.
Trial summary
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pareses, Lower Extremity
- What is being tested?
- C-Brace
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 76 sitesin 4 countries
- Study dates
- Apr 2015to Apr 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient is geographically inaccessible to comply and participate in the registry.
- Patient has not been casted for a C-Brace fitting.
Trial locations and contacts
76 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
76 sites in 4 countries
United States70 sites, 37 recruiting
- Completed
Yanke Bionics - W Exchange St
Akron, Ohio, 44302
- Terminated
Raymond G. Murphy VA
Albuquerque, New Mexico, 87108
- Recruiting
Ottobock.care
Austin, Texas, 78758
Travis Heins, (737) 707-0058, travis.heins@ottobock.com
Roger "Eric" Shoemaker, MS, CPO
- Completed
Western Reserve O&P
Austintown, Ohio, 44515
- Recruiting
Cornell Orthotics & Prosthetics
Beverly, Massachusetts, 01915
Claire Hebert, 9789222866, claire@cornelloandp.com
Claire Hebert, MSPO, CPO
- Recruiting
Orthocraft Inc. - 3856 Flatlands Ave
Brooklyn, New York, 11234
Herschel Sauber, CO, LPO
- Recruiting
ProCare Prosthetics x Ottobock.care
Buford, Georgia, 30518
Theresa Field, (770) 271-5581, tfieldr@procarepando.com
Roger "Eric" Shoemaker, CPO
- Completed
Scheck & Siress: A Hanger Clinic Company
Chicago, Illinois, 60657
- Recruiting
Wright & Filippis x Ottobock.care
Clinton Township, Michigan, 48038
Natalie Karabelski, CO, (586) 468-8289, natalie.k@wright-filippis.com
Roger "Eric" Shoemaker, CPO
- Completed
New Life
Conroe, Texas, 77384
- Recruiting
ProCare x Ottobock.care
Conyers, Georgia, 30094
James Kling, CPO/L, (770) 271-5581, jkling@procarepando.com
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
Scott Sabolich Prosthetics & Research x Ottobock.care
Dallas, Texas, 75148
Edwin Hassler, (214) 382- 9270, edwin.hassler@scottsabolich.com
Gerald Stark, PhD
- Completed
Kenney Orthopedics - Danville
Danville, Kentucky, 40422
- Completed
Kenney Orthopedics - Evansville
Evansville, Indiana, 47715
- Recruiting
Cornerstone P&O
Everett, Washington, 98203
David Hughes, 425.339.2559, dhughes@cornerstonepo.com
David Hughes
- Recruiting
Ability P&O x Ottobock.care
Exton, Pennsylvania, 19341
Thomas Martin, (800) 455-0058, thomas.martin@ottobock.com
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
AlliedOP
Fair Lawn, New Jersey, 07410
Kristen Lindsay, MSPO, CPO, 2017963121, klindsay@alliedop.com
Kristen Lindsay, MSPO, CPO
- Recruiting
P&O Care x Ottobock.care
Fairview Heights, Illinois, 62208
Dylan Borrenpohl, MS, CPO, (618) 212-0006, dylan.borrenpohl@ottobock.com
Roger "Eric" Shoemaker, CPO
- Recruiting
Wright & Filippis x Ottobock.care
Farmington Hills, Michigan, 48334
Robin Beals, BS, CPO, (248) 615-0041, robin.b@wright-filippis.com
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
Cascade Prosthetics & Orthotics
Ferndale, Washington, 98248
Larry Paise, CPO, (360) 384-1858, LarryP@Dafo.com
Larry Paise, CPO
- Recruiting
Wright & Filippis x Ottobock.care
Flint, Michigan, 48504
Ken Steel, CO, (810) 234-6582, ken.s@wright-filippis.com
Roger "Eric" Shoemaker, MS, CPO
- Completed
Prevail Prosthetics & Orthotics
Fort Wayne, Indiana, 46804
- Recruiting
Baker O&P
Fort Worth, Texas, 76104
Michael Serrano, (817) 332-7313, michael.serrano@bakerops.net
Michael Serrano, CO
- Recruiting
Ability x Ottobock.care
Frederick, Maryland, 21702
Curtis Kowalczyk, CO, (301) 698-4692, curtis.kowalczyk@ottobock.com
Taffy Bowman, CPO
- Recruiting
Bionic Prosthetics & Orthotics
Green Bay, Wisconsin, 54301
Chris Welch, MSPO, CPO, (920) 435-3002, cwelch@bionicpo.com
Daniel Chan, MBA, COA
- Active, not recruiting
Jonesboro P&O x Ottobock.care
Harrison, Arkansas, 72601
- Active, not recruiting
Hanger Clinic - Houston
Houston, Texas, 77025
- Completed
Michael E. DeBakey VA
Houston, Texas, 77030
- Completed
TIRR Research Center
Houston, Texas, 77030
- Completed
Reliable P&O
Jacksonville, North Carolina, 28546
- Completed
Excel P&O
Kingsport, Tennessee, 37660
- Recruiting
Wright & Filippis x Ottobock.care
Lansing, Michigan, 48912
Daniel Durany, CO, (517) 484-2624, dadurany@wright-filippis.com
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
Wright & Filippis x Ottobock.care
Lapeer, Michigan, 48446
Francy Lemp, CPO, (810) 664-1101, fmlemp@wright-filippis.com
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
Bionic Prosthetics & Orthotics
Lenoir, North Carolina, 28645
Kayla Watts, (828) 758-0002, lenoir@bionicpo.com
Daniel Chan, MBA, COA
- Withdrawn
Kenney Orthopedics - Lexington
Lexington, Kentucky, 40503
- Recruiting
Dankmeyer
Linthicum, Maryland, 21090
Angela Bryl, (410) 636-8114, abryl@dankmeyer.com
Angela Bryl
- Recruiting
Wright & Filippis x Ottobock.care
Livonia, Michigan, 48150
Matthew Cinader, MSOP, CPO, (734) 421-8400
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
Wright & Filippis x Ottobock.care
Madison Heights, Michigan, 48071
Mike Hoisington, BS, CO, (586) 804-6124, mike.h@wright-filippis.com
Roger "Eric" Shoemaker, MS, CPO
- Completed
VA NY Harbor
Manhattan, New York, 10010
- Recruiting
Bionic Prosthetics & Orthotics
Merrillville, Indiana, 46410
Daniel Chan, MBA, COA, (219) 791-9200, danielchan@bionicpo.com
Daniel Chan, MBA, COA
- Recruiting
AlliedOP
Mount Laurel, New Jersey, 08054
Macy Oteri, 856-273-6400, moteri@alliedop.com
Kristen Lindsay, MSPO, CPO
- Completed
MedEast Post-op & Surgical
Mount Laurel, New Jersey, 08054
- Completed
Restorative Health Services
Murfreesboro, Tennessee, 37129
- Completed
Prosthetics in Motion
New York, New York, 10001
- Recruiting
Limb Lab
Omaha, Nebraska, 68106
Vincent Lau, MS, CPO, 402-899-9110
Andrew Nelson, MS, CPO
- Recruiting
West Coast Brace & Limb - Palm Harbor
Palm Harbor, Florida, 34684
Danielle Tobler, (727) 785-0100, danielle.tobler@wcbl.com
Bridget Lawler
- Completed
Titleman Orthopedic
Philadelphia, Pennsylvania, 19083
- Completed
O&P of Pinehurst
Pinehurst, North Carolina, 28374
- Withdrawn
elizur Corporation
Pittsburgh, Pennsylvania, 15237
- Completed
Hanger Clinic - Renton
Renton, Washington, 98057
- Recruiting
Pacific Medical
Richland, Washington, 99352
Kevin Stoddard, CO, LO, (509) 371-9660, kstoddard@pacmedical.com
Riley Liddell, MS, LCPO
- Completed
Hunter Holmes McGuire VA
Richmond, Virginia, 23249
- Completed
VA O&P
Roanoke, Virginia, 24012
- Recruiting
Limb Lab
Rochester, Minnesota, 55904
Andrew Nelson, 507-322-3457, andrew@limblab.com
Andrew Nelson
- Terminated
Jonesboro P&O x Ottobock.care
Rogers, Arkansas, 72758
- Terminated
South Texas Veterans Health Care System
San Antonio, Texas, 78229
- Recruiting
Bionics Orthotics & Prosthetics
San Diego, California, 92117
Emily Rau, MSPO, CPO, 8582709972, erau@bionicsoandp.com
Emily Rau, MSPO, CPO
- Completed
ABI P&O
San Diego, California, 92120
- Active, not recruiting
Hanger - Sarasota
Sarasota, Florida, 34233
- Completed
Medical Center Orthotics & Prosthetics
Silver Spring, Maryland, 20910
- Recruiting
Carolina Ottobock.care
Spartanburg, South Carolina, 29303
John Lundquist, BOCP, COF, CPed, (864) 541-0028, jlundquist@carolinaop.com
Roger "Eric" Shoemaker, MS, CPO
- Completed
Thompson's O&P
Spokane, Washington, 99202
- Recruiting
P&O Care x Ottobock.care
St Louis, Missouri, 63131
Luke Brewer, (314) 775-2041, luke.brewer@ottobock.com
Roger "Eric" Shoemaker, MS, CPO
- Withdrawn
Freedom P & O - 356 E 600 S
St. George, Utah, 84770
- Recruiting
West Coast Brace & Limb - Tampa
Tampa, Florida, 33617
Walt Raynor, (813) 985-4499, walt.raynor@wcbl.com
Bridget Lawler
- Recruiting
Body in Motion
Toms River, New Jersey, 08755
John Caputo, (732) 244-8700
John Caputo
- Withdrawn
South County Artificial Limb and Brace
Wakefield, Rhode Island, 02879
- Recruiting
Atlantic Prosthetic Services
Wilmington, North Carolina, 28412
Bob Collins, (910) 350-0067, bob@apswilm.com
Bob Collins
- Recruiting
Ability x Ottobock.care
Wyomissing, Pennsylvania, 19610
Taffy Bowman, CPO, (610) 709-6459, taffy.bowman@ottobock.com
Roger "Eric" Shoemaker, MS, CPO
- Recruiting
Ability x Ottobock.care
York, Pennsylvania, 17401
Jonah Rhymer, MPO, CPO, (717) 851-0156, jonah.rhymer@abilitypo.com
Roger "Eric" Shoemaker, MS, CPO
Germany4 sites, 4 recruiting
- Recruiting
Ottobock Göttingen
Göttingen, Deutschland, 37075
Heiko Drewitz, +49 5513075122, heiko.drewitz@ottobock.de
Frank Braatz, Prof.
- Recruiting
John+Bamberg GmbH & Co. KG
Hanover, Lower Saxony, 30625
Sebastian Klug, sebastian.klug@john-bamberg.de
Frank Braatz
- Recruiting
Katholisches Klinikum Koblenz-Montabaur
Koblenz, Rhineland-Palatinate, 56073
Bärbel Heger, a.ruetz@kk-km.de
Axel Rütz, MD
- Recruiting
Pohlig BmbH
Traunstein, Bavaria, 83278
Annabell Jahn, +49 861-7085-200, annabell.jahn@pohlig.net
Frank Braatz
Australia1 site, 1 recruiting
- Not yet recruiting
Neuromuscular-orthotics.com.au
Clayton, Victoria, 3168
Tia Wedge, +613 1300 411 666, Tia@neuromuscular-orthotics.com.au
Sarah Anderson
Japan1 site, 1 recruiting
- Recruiting
Hyogo Rehabilitation Hospital
Kobe, Hyōgo, 651-2181
Takashi Oshima, 000-000-0000, t_ooshima@hwc.or.jp
About this study
Official title: A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.
Read the 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.
- Conditions
- Pareses, Lower Extremity
- Being tested
- C-Brace
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-BraceDevice
Also called Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
The PSFS is a self-report measure aimed at identifying functional status limitations that are most relevant to individual patients.The PSFS is a reliable, valid, and efficient measure for detecting clinical change in persons with low back pain and knee dysfunction. Patients will be asked to identify three to five activities that they are having difficulty or are unable to perform because of their injury/condition. For the specified activities, patients will then be asked to rate their ability to perform each activity at that time (0-10 numerical scale) with '0' being unable to perform the activity, and '10' being able to perform the activity at the same level as they could prior to the injury/condition. There is no total score for this measure.
Measured: 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
On the day the patient is casted for the C-Brace the patient's current orthosis will be affixed with an activity monitor to record the number of steps the patient takes with the orthosis. The patient will be sent home with a prepaid envelope and be instructed to mail back the activity monitor 16 days later, in order to capture 14 whole days of step count data. The step counts will be downloaded from the device the day the activity monitor is returned to the Investigator. The C-Brace will also be affixed with the same activity monitor following the same process for when the activity monitor was attached to the previous orthosis.
Measured: Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker
Berg Balance Scale (BBS)
The BBS is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner. The points reached in each item were summed up to the total score.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study startApr 2015
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParesesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Braatz, Prof., Principal investigator, Private University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640584
- Sponsor's protocol ID
- PD-PS00120018A-001
- Status last verified
- Apr 2025
- First submitted
- 17 Nov 2020
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39132469
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
- ClinicalTrials.gov ID
- NCT04640584
- Acronym / sponsor ID
- PD-PS00120018A-001
- Conditions
- Pareses, Lower Extremity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient is geographically inaccessible to comply and participate in the registry.
- Patient has not been casted for a C-Brace fitting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-BraceAlso: Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)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. | Device | – |
Primary outcome
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
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.
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.
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.
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.
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.
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
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 39132469Lundstrom 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.
- Individual participant dataSharing planned: No
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Muscular Diseases, Neuromuscular Manifestations
RecruitingPhase 1/2
PBGENE-DMD Phase 1/2a Safety and Preliminary Efficacy Study in Duchenne Muscular Dystrophy (FUNCTION-DMD)
Duchenne Muscular Dystrophy With Mutations Amenable to PBGENE-DMD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Braatz, Prof. principal investigator
Private University of Applied Sciences
76 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pareses and Lower Extremity, run by Otto Bock Healthcare Products GmbH at 76 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Germany, Australia, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Russell L Lundstrom, MS (512-806-2606, russ.lundstrom@ottobock.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04640584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.