Multinational Randomized Controlled Cross-over Trial Comparing C -Brace to Conventional Knee Ankle Foot Orthoses With Respect to Balance, Fall Risk and Activities of Daily Living
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 23
- 主要终点
- Primary Efficacy: Berg Balance Scale (BBS)
研究概览
简要总结
Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses
详细描述
After obtaining informed consent, patients will be screened. For subjects fulfilling inclusion/exclusion criteria, a first baseline assessment will be conducted. Within one to two days, a second set of baseline data will be collected for performance measures. Subjects will then be randomly assigned to be fitted with C-Brace or to continue wearing the current KAFO/SCO. After fitting, an accommodation period follows that will last up to 14 days prior to the initial home use. The first follow-up data collection will occur after three months of the initial home use period. Afterwards, the patients will cross over to KAFO/SCO or C-Brace, respectively. The participants who were fitted with C-Brace will cross over to KAFO/SCO and vice versa. Another accommodation phase will be offered for both C-Brace and KAFO/SCO wearers to ensure that subjects can properly use both devices before the cross-over home use period. The second follow-up data collection will occur after 3-months of the cross-over home use period. At the end of the study, the patients can choose to keep the C-Brace for up to 24 months until reimbursement or to return to their original KAFO/SCO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been tested with the Trial Tool (DTO) and demonstrated the potential to utilize the C-Brace successfully
- •Patient has a BBS score < 45
- •Lower limb functional impairment according to CE label wording
- •Prior active and compliant use of unilateral or bilateral KAFO or SCO in the past 3 months prior to enrollment in the study
- •Patient meets minimum physical requirements to be fitted with a C-Brace, such as muscle status, joint mobility, leg axis and proper control of the orthosis must be guaranteed.
- •The User must fulfill the physical and mental requirements for perceiving optical/acoustic signals and/or mechanical vibrations
- •The existing muscle strength of the hip extensors and flexors must permit the controlled swing-through of the limb (compensation using the hip is possible).
- •Patient´s commitment to use C-Brace 2 at least 1-2 hours per day 5 days per week-
- •Patient is ≥ 18 years old
- •Patient is willing and able to independently provide informed consent.
- •Person is willing to comply with study procedures
排除标准
- •Patient who is not able to follow the entire study visits or is unwilling/unable to follow the instructions
- •Patient was not able to use DTO
- •Patient who is not using an orthosis at least 1 to 2 hours/ day for 5 days per week
- •Patient with body weight > 125 kg (includes body weight and heaviest object (weight) carried)
- •Patient with Orthoprosthesis
- •Patient with flexion contracture in the knee and/or hip joint in excess of 10°
- •Patient with uncontrolled moderate to severe spasticity (relative contraindication moderate spasticity)
- •Leg length discrepancy in excess of 15 cm
- •Patient with unstable neurological or cardiovascular/pulmonary disease, cancer
- •Pregnancy
- •Patient using a C-Brace
- •Patient with known vertigo or with history of falls unrelated to orthosis use or unrelated to motor disability
- •Patient who has never been fitted an orthosis before
- •Patient is not able to answer the self-administered questionnaires independently; for patients with upper extremity impairment is it allowed to verbally answer the questions.
- •Patient participating already in a study during this study´s duration
- •Patient participated in earlier C-Brace studies
结局指标
主要结局
Primary Efficacy: Berg Balance Scale (BBS)
时间窗: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
The Berg Balance Scale 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.
次要结局
- Activity-specific Balance Confidence (ABC) Scale(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Dynamic Gait Index (DGI)(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- 6-minute Walk Test(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Stair Assessment Index (SAI) - Down(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Frequency of Falling(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Fear of Falling(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO(3 months after initial home use period, and 3 months after cross-over home use period)
- Reintegration to Normal Living (RNL) Index Questionnaire(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- EQ-5D-5L(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Work Limitations Questionnaires WLQ-25(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Orthotics & Prosthetics User Survey (OPUS)(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Medical Outcomes Study Short Form (SF-36)(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)(Baseline, 3 months after initial home use period, and 3 months after cross-over home use period)
- Patient-Related Outcome Questions(3 months after cross-over home use period)