The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Health-related quality of life (HRQoL)
研究概览
简要总结
The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will:
- Identify the factors that significantly contribute to an individual's highest potential quality of life when considering each of the three available AFO design options, and
- Develop prediction models of clinical performance using biomechanical function linked to the three AFO designs.
Participants will be asked to:
- Wear each of the three modern AFO designs for one month, after receiving therapy training and
- Complete questionnaires and performance tests with each AFO.
In addition, the subset of individuals participating in goal 2) will also be asked to:
- Perform biomechanical analyses using high-speed cameras and force plates during different walking and balance tests with each AFO design.
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
- •be a minimum of three months post-stroke
- •be greater than 18 years of age
- •have been prescribed either a semi-rigid or a custom-made articulating AFO
- •wear their prescribed AFO for all primary mobility activity outside the house
- •be able to walk at least 20 meters without manual assistance
- •walk at least 10 meters per minute (12% of normal velocity) during a 6-meter self-selected velocity walking test.
排除标准
- •having a condition that could significantly limit ambulation, including severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or pre-existing neurological disorder other than post-stroke
- •having cognitive deficits that preclude their ability to provide consent for participation
- •having an ankle plantar flexion contracture equal to or greater than 15 degrees plantar flexion with full knee extension
研究组 & 干预措施
PF-CS-MA
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the carbon strut (CS) AFO, and finally the multifunctional articulating (MA) AFO.
干预措施: Pre-fabricated (PF) ankle-foot orthosis (AFO) (Device)
PF-CS-MA
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the carbon strut (CS) AFO, and finally the multifunctional articulating (MA) AFO.
干预措施: Carbon-strut (CS) ankle-foot orthosis (AFO) (Device)
PF-CS-MA
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the carbon strut (CS) AFO, and finally the multifunctional articulating (MA) AFO.
干预措施: Multifunctional articulating (MA) ankle-foot orthosis (AFO) (Device)
PF-MA-CS
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the multifunctional articulating (MA) AFO, and finally the carbon strut (CS) AFO.
干预措施: Pre-fabricated (PF) ankle-foot orthosis (AFO) (Device)
PF-MA-CS
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the multifunctional articulating (MA) AFO, and finally the carbon strut (CS) AFO.
干预措施: Carbon-strut (CS) ankle-foot orthosis (AFO) (Device)
PF-MA-CS
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the multifunctional articulating (MA) AFO, and finally the carbon strut (CS) AFO.
干预措施: Multifunctional articulating (MA) ankle-foot orthosis (AFO) (Device)
CS-PF-MA
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the pre-fabricated (PF) AFO, and finally the multifunctional articulating (MA) AFO.
干预措施: Pre-fabricated (PF) ankle-foot orthosis (AFO) (Device)
CS-PF-MA
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the pre-fabricated (PF) AFO, and finally the multifunctional articulating (MA) AFO.
干预措施: Carbon-strut (CS) ankle-foot orthosis (AFO) (Device)
CS-PF-MA
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the pre-fabricated (PF) AFO, and finally the multifunctional articulating (MA) AFO.
干预措施: Multifunctional articulating (MA) ankle-foot orthosis (AFO) (Device)
CS-MA-PF
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the multifunctional articulating (MA) AFO, and finally the pre-fabricated (PF) AFO.
干预措施: Pre-fabricated (PF) ankle-foot orthosis (AFO) (Device)
CS-MA-PF
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the multifunctional articulating (MA) AFO, and finally the pre-fabricated (PF) AFO.
干预措施: Carbon-strut (CS) ankle-foot orthosis (AFO) (Device)
CS-MA-PF
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the multifunctional articulating (MA) AFO, and finally the pre-fabricated (PF) AFO.
干预措施: Multifunctional articulating (MA) ankle-foot orthosis (AFO) (Device)
MA-PF-CS
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the pre-fabricated (PF) AFO, and finally the carbon strut (CS) AFO.
干预措施: Pre-fabricated (PF) ankle-foot orthosis (AFO) (Device)
MA-PF-CS
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the pre-fabricated (PF) AFO, and finally the carbon strut (CS) AFO.
干预措施: Carbon-strut (CS) ankle-foot orthosis (AFO) (Device)
MA-PF-CS
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the pre-fabricated (PF) AFO, and finally the carbon strut (CS) AFO.
干预措施: Multifunctional articulating (MA) ankle-foot orthosis (AFO) (Device)
MA-CS-PF
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the carbon strut (CS) AFO, and finally the pre-fabricated (PF) AFO.
干预措施: Pre-fabricated (PF) ankle-foot orthosis (AFO) (Device)
MA-CS-PF
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the carbon strut (CS) AFO, and finally the pre-fabricated (PF) AFO.
干预措施: Carbon-strut (CS) ankle-foot orthosis (AFO) (Device)
MA-CS-PF
Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the carbon strut (CS) AFO, and finally the pre-fabricated (PF) AFO.
干预措施: Multifunctional articulating (MA) ankle-foot orthosis (AFO) (Device)
结局指标
主要结局
Health-related quality of life (HRQoL)
时间窗: Over the real-world use period (4 weeks) for each AFO
Health-related quality of life (HRQoL) is a framework that considers physical, mental, emotional, and social function when assessing the satisfaction of AFO users with their AFO.
次要结局
未报告次要终点
研究者
Rick Neptune
Professor
University of Texas at Austin