Application of Functional Electrical Stimulation Therapy Coupled to a P300-based Brain-Computer Interface for Paretic Upper Limb Rehabilitation in Chronic Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Upper limb motor recovery
研究概览
简要总结
The objective of this research is to evaluate the efficacy of an experimental therapy for motor recovery of the arm after a stroke, which includes the application of a functional electrical stimulation therapy coupled to P-300 based Brain-Computer Interface system (BCI-FES). For this purpose, the investigators will compare two groups, the first one will receive only conventional physical therapy, while the second one will receive physical conventional therapy together with BCI-FES therapy.
The control and experimental group will receive 20 sessions of conventional physical therapy at a rate of five sessions per week for 4 weeks, and the experimental group will receive 20 sessions of rehabilitation with the BCI-FES system at a rate of five sessions per week for 4 weeks. Broadly speaking, the BCI is in charge of determining the movement selected by the individual and assist the hand movement while performing functional tasks. The movements included in the sessions will be hand opening, grasping, pinching, pronation and supination, which are combined to facilitate the execution of functional movements that are performed together with the manipulation of daily used utensils. The visual, sensory and motor feedback provided by the BCI-FES system that enables the individual to replicate the afferent-efferent motor circuit, contributes to the activation and recruitment of neural pathways, which is associated with motor recovery.
It should be noted that this BCI-FES system has already been tested previously in a study with healthy individuals, and in a non-randomized pilot study that used this therapy for upper limb motor function recovery in chronic post-stroke patients. It showed positive results, and the therapy was safe and tolerated by all the patients. Besides no adverse event related to the intervention occurred.
To evaluate the results, a series of tests will be applied to assess the motor recovery and level of independence, including the FMA-UE: Fugl-Meyer Assessment Scale of Upper Extremity, ARAT: Action Research Arm Test, MAS: Modified Ashworth Scale, FIM: Functional Independence Measure and MAL: Motor Activity Log. Moreover, to assess neuroplasticity, two neuroimaging techniques including magnetic resonance imaging and electroencephalography will be used.
详细描述
About one third of patients who suffer a stroke remain with a severe and permanent disability, secondary to motor sequelae and reduced mobility. Physical and occupational therapy represents the main rehabilitation alternative in patients with paretic upper limb, however, despite this, after six months of the event about two thirds of the patients will still be unable to use the affected limb in their daily life activities.
This has led to the development of new therapeutic alternatives able to enhance the effects of conventional physical therapy. The use of brain-computer interfaces represents a paradigm in neurorehabilitation of the upper limb since it can interpret the users intentions and allow them to interact with the environment by facilitating motion execution. Some effector devices that facilitate this movement execution have been tested, with functional electrical stimulation being one of the most used.
Therefore, the objective of this research is to evaluate the efficacy of an experimental therapy for motor recovery of the arm after a stroke, which includes the application of a functional electrical stimulation therapy coupled to P-300 based Brain-Computer Interface system (BCI-FES). For this purpose, the investigators will compare two groups, the first one will receive only conventional physical and occupational therapy, while the second one will receive conventional therapy together with BCI-FES therapy.
Twenty-six subjects with moderate to severe paretic upper limb and history of chronic stroke will be invited to participate in the study. These will be recruited through the patient database of the neurological rehabilitation department of the National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra (INRLGII), in addition to patients recommended by the stroke rehabilitation department.
They will be randomized into two groups: the experimental group will receive P300-BCI-FES therapy together with conventional physical therapy and the control group will receive only conventional physical therapy. They will be randomly assigned to either group according to a big stick design and covariate-adaptive randomization method, considering the following variables for stratification: type of stroke (ischemic/hemorrhagic) and chronicity, baseline Fugl-Meyer Assessment Scale of Upper Extremity score, and age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Patients with ischemic or hemorrhagic stroke (evidenced by CT or MRI)
- •≥6 months from stroke onset, chronic phase
- •Unilateral lesion
- •Age ≥18 years
- •Moderate-severe hemiparesis (FMA-UE: ≤45)
- •Full passive ranges of motion in the elbow, forearm, wrist, and hand
- •Minimal cognitive level necessary to follow instructions and complete tasks
- •Desire to participate in the study
排除标准
- •Neurological disorders (Parkinsons disease, epilepsy, dementia)
- •Neurological or musculoskeletal condition directly affecting the upper limb (dystonia, severe spasticity -muscle tone for elbow, wrist and fingers > 3 according to modified Ashworth scale-)
- •Contraindications for MRI (implantable devices -pacemakers-, claustrophobia, others)
- •Cognitive deficit (MoCA <20 points)
- •Severe aphasia
- •Severe psychiatric disorders
- •More than one stroke
结局指标
主要结局
Upper limb motor recovery
时间窗: It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).
Fugl-Meyer Assessment Scale of Upper Extremity (FMA-UE), Minimum Value: 0 - Maximum Value: 66, Higher Score = Better Outcome.
次要结局
- Upper limb functional independence.(It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).)
- Structural Anatomy, Structural Connectivity and Functional Connectivity(It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).)
- Upper limb spasticity(It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).)
- Upper limb function(It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).)
- Upper limb functional independence(It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).)
- Severity of depression(It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).)
研究者
Jimena Quinzaños
Principal Investigator, Head of the Neurological Rehabilitation Department
Instituto Nacional de Rehabilitacion