Micro-processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Versus Stance-control Knee-Ankle-Foot Orthosis (SCO): Functional Outcomes in Individuals With Lower Extremity Impairment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Six minute walk test (6MWT)
研究概览
简要总结
The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
- •Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
- •Age 18 - 80 years.
- •Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
- •Cognitive ability to understand and the willingness to sign a written informed consent.
- •Subjects must be able to demonstrate the ability to turn the global positioning sensor (GPS) and Actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
排除标准
- •Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
- •Body weight >275 pounds.
- •Unstable neurological or cardiovascular/pulmonary disease, cancer.
- •Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
- •Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
研究组 & 干预措施
C-brace then stance control orthosis
干预措施: C-brace (Device)
C-brace then stance control orthosis
干预措施: Stance control orthosis (Device)
Stance control orthosis then C-brace
干预措施: C-brace (Device)
Stance control orthosis then C-brace
干预措施: Stance control orthosis (Device)
结局指标
主要结局
Six minute walk test (6MWT)
时间窗: Change from baseline in 6MWT using device 1 at 8 weeks and using device 2 at 16 weeks.
The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.
次要结局
- Muscle strength(Change from baseline in muscle strength after device 1 use at 8 weeks and after device 2 use at 16 weeks.)
- Passive and active range of motion(Change from baseline in range of motion after device 1 use at 8 weeks and after device 2 use at 16 weeks.)
- 10 meter walk test(Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks.)
- Hill Assessment Index(Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks.)
- Stair Assessment Index(Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks.)
- Cross Walk Blinking Signal Test(Change from baseline in the Cross Walk Blinking Signal Test using device 1 at 8 weeks and using device 2 at 16 weeks.)
- GAITRite Data Capture(Change from baseline in gait parameters using device 1 at 8 weeks and using device 2 at 16 weeks.)
- Berg Balance Scale(Change from baseline in Berg Balance Scale score using device 1 at 8 weeks and using device 2 at 16 weeks.)
- Functional Gait Assessment(Change from baseline in Functional Gait Assessment scores using device 1 at 8 weeks and using device 2 at 16 weeks.)
- 5 times sit to stand test(Change from baseline in 5 times sit to stand test using device 1 at 8 weeks and using device 2 at 16 weeks.)
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab