Assessing the Feasibility and Safety of a Combined Closed Loop Functional Electrical Stimulation and Augmented Reality System for Individuals With Cervical Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
Cervical spinal cord injury (cSCI) can result in substantial loss of upper-limb function, with associated socio-economic impact on affected individuals and the healthcare system. Evidence suggests that non-invasive neuromodulation such as functional electrical stimulation (FES) therapy can contribute to regaining upper-limb function, which is a top priority for this population. This pilot study will involve individuals with cSCI using a device that combines augmented reality (AR) and functional electrical stimulation (FES) for 20, one-hour sessions over a 10-week period. The sessions will include upper-limb rehabilitation where individuals will interact with different objects with the aid of the AR +FES system. The primary objective is to assess safety and feasibility, measured by the absence of serious adverse events and participants' ability to independently set up and use the system. Secondary objectives include adherence to the intervention and user feedback through structured interviews. Exploratory outcomes will examine preliminary efficacy using clinical measures such as the Spinal Cord Independence Measure (SCIM) and the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic cervical SCI
- •Any level or severity of cervical SCI, traumatic or non-traumatic
- •Can carry out object manipulations but with visible impairment (i.e., 5-25 on the GRASSP Prehension Performance sub-score).
排除标准
- •Any disease or injury other than the SCI that may be affecting grasping performance.
- •Individuals with any self-reported FES contraindications (pacemakers, implantable defibrillator, implanted neurostimulation device, metallic implants in the stimulated areas, cardiac conditions, epilepsy, uncontrolled seizures, wounds or fractures on the target limb)
- •Inability to understand the study procedures
- •Muscles do not respond to FES to produce grasping movements
- •Currently participating in another upper limb rehabilitation intervention study (regular physical and occupational therapy is permitted).
结局指标
主要结局
Adverse events
时间窗: Week 1 to week 14.
Presence of adverse and serious adverse events. These will be recorded during each session. The criterion for success is no study-related serious adverse events and no study-related adverse events that cannot be alleviated by stopping electrical stimulation.
Feasibility - Set-up time
时间窗: During experimental sessions from week 1 to week 10.
The study will track independence with the system by assessing set-up time.
Feasibility - Assistance required.
时间窗: During experimental sessions from week 1 to week 10.
The study will track independence with the system by assessing the number of times assistance is requested.
次要结局
- Adherence(During experimental sessions from week 1 to week 10.)
- User feedback(Discharge assessment at week 10.)