Creating an Engaging BCI/FES Therapy for Children With Perinatal Stroke Using Social Media
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Training accuracy and Cohen' Kappa
研究概览
简要总结
The goal of this trial is to evaluate the feasibility of a brain-computer interface controlled functional electrical stimulation (BCI-FES) social media integrated system for children with hemiparetic cerebral palsy . The main questions it aims to answer is:
(1) Is the social media BCI-FES system a feasible therapeutic intervention?
详细描述
Perinatal strokes are focal neurovascular brain injuries that affect 5 million people worldwide and can lead to lifelong physical disabilities. It is the leading cause of hemiparetic cerebral palsy (HCP) which is characterized as motor dysfunction on one side of the body. Even modest improvements in a child's hand function can positively impact participation and affect quality of life, which is why there is a push for therapeutic interventions during earlier developmental windows.
Functional electrical stimulation (FES) stimulates muscle contraction during activity performance through low-intensity electrical currents. When applied to the affected limb, it can reduce spasticity-related symptoms and improve range of motion (ROM) and strength. When a patient's attempted movement is paired with FES, it triggers the cortical activation of sensorimotor areas, the degree of which has been associated with functional improvement. In stroke rehabilitation guidelines for adults, upper extremity FES receives the highest evidence-based recommendation. However, it has not been adequately studied in children, largely due to challenges with engagement, since high repetition counts are required to achieve meaningful functional gains. Brain Computer Interfaces (BCI) work by converting intentional brain activity into commands that can be used to control external devices. BCIs have been recently under investigation for their role in stroke rehabilitation.Specifically, BCI paired with FES has been explored as a novel way to drive task-related neuroplasticity to improve motor impairments over time in adults with stroke. Evidence suggests BCI-FES may be effective in adult patients with stroke-induced hemiparesis. Despite the evidence of enhanced neuroplasticity, the use of FES and BCI in children remains limited. One study suggested BCI-FES is feasible and well-tolerated in children with perinatal stroke, but scored poorly on enjoyability, suggesting that uptake and engagement in the therapy require improved system design. Which is why, the investigators created a novel and engaging BCI-FES therapy designed for youth with the aim of increasing long-term efficacy.
Methods:
A multi-disciplinary team of therapists, engineers, researchers, clinicians, and patient partners helped design a BCI FES therapy that is integrated with social media. The resulting application was named FlickTok, a novel BCI/FES social media therapy system. FlickTok integrates three interacting components: 1) an EEG headset, 2) the FES system, and 3) an application to coordinate the two components with social media interactions.
Patient Partner Engagement The investigators engaged three youth patient partners to design and build a BCI-FES integrated with social media to ensure research focus was on patient identified priorities. Before development began, the investigatorsworked with the patient partners to ensure that the system aligned with target users They helped us pilot test the system to evaluate and improve technical performance and usability. Our patient partners were also actively involved in the study design, helping to develop and conduct the qualitative interviews and supported results interpretation.
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
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators recruited participants 10-25 years, with perinatal stroke and disabling hemiparetic cerebral palsy.
排除标准
- •Exclusion criteria include severe intellectual disability, unstable epilepsy, and orthopaedic surgery in the upper limb or botulinum toxin injection in the previous 6 months.
结局指标
主要结局
Training accuracy and Cohen' Kappa
时间窗: Taken on Day 1, Day 2 and Day 3 of the study
Cohen's kappa (a quantification of agreement in attempt accuracy) was calculated by defining a true positive value (TP) as FES being triggered within 6 seconds of the participant attempting a movement and defining false positive (FP) as the FES firing without an attempted movement. A true negative (TN) was defined as 6 seconds of the FES not firing when the participant did not attempt movement. A false negative (FN) was defined if the participant attempted a movement and Flick Tok did not trigger the FES for 6 seconds, in this case, the video was manually swiped. Repetitions with excessive movement/talking were removed for this calculation. Values were extracted by reviewing videos of participants during the three sessions. Cohen's kappa (κ): κ=(2(TP× TN- FN× FP))/((TP+FP)×(FP+TN)+(FP+ FN) ×(FN+TN)) Offline accuracy was extracted using a Riemannian Geometry based motor imagery classifier.
次要结局
- Qualitative Interview(Day 3)
- Enjoyability survey(end of session on Day 1, Day 2, Day 3)
- Range of Motion Assessment(ROM was taken immediately before and immediately after the intervention (day 1, day 2, day 3))
- Box and Blocks Assessment(The box and blocks assessment was completed immediately before and immediately after the intervention (day 1, day 2, day 3))
- Repetitions with and without electrical stimulation(Repetition were recorded during the sessions (day 1, day 2, day 3))
研究者
Adam Kirton
Pediatric Neurologist
University of Calgary