Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Timed Up and Go (TUG) test
研究概览
简要总结
The Smart Ankle-Foot Orthosis (Smart AFO) system is an investigational system that combines a diagnostic ankle-foot orthosis with a mobile application to assist clinicians in optimizing an AFO user's gait by adjusting AFO stiffness and range of motion settings, and quantifying functional walking improvements in post-stroke individuals. The purpose of the clinical testing is to evaluate the Smart AFO system with its target users: post-stroke AFO users and orthotists. This may include, but is not limited to, identifying any aspects of the Smart AFO system that could be improved through clinical testing and evaluating the gait of post-stroke AFO users walking with an AFO adjusted using the Smart AFO system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Age 18 years or older
- •Mass less than 90 kg (200 lbs)
- •At least six months post-stroke
- •Hemiplegia or hemiparesis as a result of stroke
- •Foot drop during swing phase (often identified by a toe catch), on at least one side
- •Current user of an AFO
- •Current user of an AFO with a Triple Action Joint is acceptable
- •Has bilateral passive ankle range of motion within normal limits
- •Able to walk safely on level ground for at least 100 feet without rest
- •Able to communicate individual perceptions in the English language
- •Able to provide written informed consent
- •Participants that will use a treadmill during data collection must also be able to walk independently and safely on an instrumented treadmill
排除标准
- •Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation
- •Pregnancy
- •Not able to read and understand English
- •Use of assistive device that requires bilateral upper extremities
结局指标
主要结局
Timed Up and Go (TUG) test
时间窗: Assessed on day 1 (data collection day) with Smart AFO
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Measured in seconds.
Ankle power
时间窗: Assessed on day 1 (data collection day) with Smart AFO
Average peak ankle joint power during stance phase (Newton-meters/second)
Knee angle
时间窗: Assessed on day 1 (data collection day) with Smart AFO
Average knee joint angle at midstance (degrees)
Knee power
时间窗: Assessed on day 1 (data collection day) with Smart AFO
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Ankle dorsiflexion
时间窗: Assessed on day 1 (data collection day) with Smart AFO
Average ankle joint angle during midswing (degrees)
Ankle plantarflexion
时间窗: Assessed on day 1 (data collection day) with Smart AFO
Average ankle joint angle at foot flat after initial contact (degrees)
次要结局
- Stride length(Assessed on day 1 (data collection day) with Smart AFO)