Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury (Eficacia de Una Terapia Con estimulación eléctrica Funcional Controlada Con Interfaz Cerebro-computadora Para neurorrehabilitación de Pacientes Con lesión Medular)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Capabilities of Upper Extremities Questionnaire (CUE-Q)
研究概览
简要总结
The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Spinal Cord Injury at neurological levels C6 or C7
- •American Spinal Injury Association (ASIA) classification A, B, C or D
- •Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale
- •Time since disease onset of more than 6 months and less than 60 months
- •Normal or corrected to normal vision
排除标准
- •Severe attention deficits
- •Previous diagnosis of traumatic brain injury
- •Previous diagnosis of peripheral nerve injury
- •Previous stroke diagnosis
- •Previous diagnosis of neurodegenerative diseases
- •History of fractures in upper extremities
- •Skin lesions
- •Contractures in upper extremities that hamper mobility
- •Excessive muscle spasms
研究组 & 干预措施
Brain-Computer Interface controlled functional electrical stimulation feedback
干预措施: Brain-Computer Interface (Device)
Sham Brain-Computer Interface controlled functional electrical stimulation feedback
干预措施: Sham Brain-Computer Interface (Device)
结局指标
主要结局
Capabilities of Upper Extremities Questionnaire (CUE-Q)
时间窗: At enrollment and after 7 weeks of the intervention onset
Change of the functional limitation in tetraplegia. Scale ranges from 32 to 224 points if both upper limbs are assessed. A higher score means less functional limitation outcome.
Action Research Arm Test (ARAT)
时间窗: At enrollment and after 7 weeks of the intervention onset
Change of upper limbs function. Scale ranges from 0 to 57 points for each upper limb. A higher score means a better upper limb function.
Upper Extremity Motor Score (UEMS)
时间窗: At enrollment and after 7 weeks of the intervention onset
Change of upper limbs function. Scale ranges from 0 to 50 points if both upper limbs are assessed. A higher score means a better upper limb function.
次要结局
- Spinal Cord Independence Measure III (SCIM-III)(At enrollment and after 7 weeks of the intervention onset)
- Life Satisfaction Questionnaire 9 (LISAT-9)(At enrollment and after 7 weeks of the intervention onset)
研究者
Jessica Cantillo-Negrete
Researcher in Medical Sciences
Instituto Nacional de Rehabilitacion