Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in 10 Meter Walk Test speed
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use.
Participants will:
- Wear a sensor that records everyday activities and mobility.
- Perform measures of mobility and different activities of participation using their own brace.
- Perform measures of mobility and different activities of participation using the Nomad powered KAFO
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma
- •Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
- •Willing to wear and charge an activity monitor for three-months home trials.
排除标准
- •Flexion contracture in the knee and/or hip joint in excess of 15 degrees
- •Non-correctable knee varus/valgus in excess of 15 degrees
- •Severe spasticity
- •Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
研究组 & 干预措施
Group A
Group A receives the intervention Nomad KAFO first; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing.
干预措施: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) (Device)
Group B
Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing.
干预措施: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) (Device)
结局指标
主要结局
Change in 10 Meter Walk Test speed
时间窗: Baseline, Post 3-month home trials with each device
A test to measure the change of speed of both self selected and fastest walking speeds
次要结局
- Hill Assessment Index(Baseline, Post 3-month home trials with each device)
- Functional Gait Assessment(Baseline, Post 3-month home trials with each device)
- World Health Organization Quality of Life(Baseline, Post 3-month home trials with each device)
- Borg Rate of Perceived Exertion(Baseline, Post 3-month home trials with each device, and as needed throughout course of study)
- Berg Balance Test(Baseline, Post 3-month home trials with each device)
- Modified Falls Efficacy Scale(Baseline, Post 3-month home trials with each device)
- Range of Motion (both passive and active)(Screening, Baseline, Post 3-month home trials with each device)
- Stair Assessment Index(Baseline, Post 3-month home trials with each device)
- Timed Up and Go(Baseline, Post 3-month home trials with each device)
- Activities Specific Balance Confidence Scale(Baseline, Post 3-month home trials with each device)
- EQ5D-5L(Baseline, Post 3-month home trials with each device)
- Numeric Pain Rating Scale(Baseline, Post 3-month home trials with each device, and as needed throughout course of study.)
- Manual Muscle Test(Screening, Baseline, Post 3-month home trials with each device)
- Six Minute Push Test(Baseline, Post 3-month home trials with each device)
- Six Minute Walk Test(Baseline, Post 3-month home trials with each device)
- Orthotics and Prosthetics User Survey(Baseline, Post 3-month home trials with each device)
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab