A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 62
- 主要终点
- Primary Efficacy: Activities-specific Balance Confidence (ABC)
研究概览
简要总结
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient is geographically inaccessible to comply and participate in the registry.
- •Patient has not been casted for a C-Brace fitting.
结局指标
主要结局
Primary Efficacy: Activities-specific Balance Confidence (ABC)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)