Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cionic, Inc.
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Mean Dorsiflexion at Heel Strike
研究概览
简要总结
The objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (FES) of the lower leg to improve gait in people with foot drop.
详细描述
Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. All participants will receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets. Participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). The primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70
- •Lower extremity impairment that makes walking difficult or uncomfortable
- •Capable of sitting, standing, and walking independently or with assistance
- •Able to walk at least 50 feet independently or with assistance
- •Able to understand and follow basic instructions in English
排除标准
- •Have non-reversible damage to the peripheral nervous system
- •Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices
- •Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent
- •Have lower motor neuron disease or injury that may impair response to stimulation
- •Are pregnant
- •Are under the age of 18 years old
- •Have skin conditions of the affected lower limb, including cuts, burns or lesions
结局指标
主要结局
Mean Dorsiflexion at Heel Strike
时间窗: 60 minutes
Dorsiflexion measured via inertial measurement unit (IMU) sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe.
Mean Ankle Inversion During Swing Phase
时间窗: 60 minutes
Ankle inversion measured via IMU sensors placed on the foot and lower leg, measured in degrees. Swing phase is determined from pressure sensors in the shoe
次要结局
- Mean Heel-Toe Time as a Percent of Gait Cycle(60 minutes)
- Mean Foot Angle at Heel Strike(60 minutes)
研究者
Rebecca Webster
Clinical Operations
Cionic, Inc.