Lower Extremity, Pareses
Conditions
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.
Interventions
DEVICEC-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.
Sponsors
Otto Bock Healthcare Products GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Frequency and severity of falling | 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. |
| Primary Efficacy: Timed Walk Test | 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: Activities-specific Balance Confidence (ABC) | 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 Efficacy: Timed Up and Go (TUG) Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Tracker | Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the 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. |
| 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. | 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. |
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | The NPRS is a valid and reliable measure of pain that may be used across all musculoskeletal injuries/conditions and complements the Patient Specific Functional Scale (PSFS). The patient will be asked to rate the pain of their joints, foot, lower back, and if they are using an assistive device any additional affected limbs on average over the last 24 hours on a scale 1-10, with '1' being 'very mild' and '10' being the 'unimaginable unspeakable'. There is no total score for the NPRS. |
| PROMIS Pain Interference - Short Form 6a | 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. | PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. For this registry the Pain Interference - Short Form 6a has been chosen for use by the patient. The patient will be asked six questions related to how pain may have interfered with certain activities in the last 7 days, and rate them on a 1-5 scale, with '1' being 'not at all' and '5' being 'very much.' To find the total raw score for the short form, the values of the responses are summed. The raw score is then converted to a T-Score. A higher PROMIS T-score represents more of the concept being measured. |
| 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. | Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. These weights, sometimes referred to as 'utilities', are often used to compute QALYs for use in health economic analyses. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. |
| 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. | The Manual Muscle Test is using a grading system of 0-5 in muscles of the lower body (hip, knee, ankle), 0 indicating none muscle strength at all, 5 means normal. In addition, assessments for range of motion, contractures, and alignment in the lower limb will all be recorded.There is no total score for these assessments |
Countries
Australia, Germany, Japan, United States
Contacts
Primary ContactRussell L Lundstrom, MS
Backup ContactBarbara Pobatschnig, MSc
Outcome results
None listed