Time Sensitivity of Adaptive Neuroplasticity and Functional Recovery Related to FEST in Combination with TST for Rehabilitation of Upper Extremity Function of Individuals with Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Spinal Cord Independence Measure (SCIM)
研究概览
简要总结
The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific training (FEST+TST) following spinal cord injury (SCI) influences functional and neurological recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI
排除标准
- •Contraindications for neurophysiological tests
- •Contraindications for FEST
- •Medical conditions that can limit treatment protocols
- •Other neurological diseases (i.e. peripheral neuropathies)
- •Significant persisting mental illness;
- •Learning disabilities;
- •Substance abuse over 6 months prior to recruitment;
- •Hearing and visual deficits sufficient to affect test performance;
- •Contraindication to MRI scanning
结局指标
主要结局
Spinal Cord Independence Measure (SCIM)
时间窗: Change from baseline SCIM at 3 & 6 months
Self-care SCIM subscore (0-20) and total SCIM score (0-100) will be used to assess the degree of disability for individuals with SCI with respect to activities of daily living; higher scores reflect greater degree of functional independence
American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS)
时间窗: Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])
International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.
Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
时间窗: Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])
The GRASSP is a clinical measure used to evaluate upper limb impairment following SCI across 3 domains: strength, sensation, and prehension.
ASIA Upper-Extremity Sensory Score (UESS)
时间窗: Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])
International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.
次要结局
- Repetitive Nerve Stimulation(Change in baseline neuromuscular junction transmission at 3 & 6 months)
- Laboratorial Assessments (BDNF)(Change in baseline BDNF at 3 & 6 months)
- Needle Electromyography(Change in baseline EMG activity at 3 & 6 months)
- F-Wave(Change in baseline F-wave amplitude at 3 & 6 months)
- Nerve Conduction Studies(Change in baseline nerve conduction at 3 & 6 months)
- H-Reflex(Change in baseline H-reflex amplitude at 3 & 6 months)
- Somatosensory Evoked Potentials (SSEPs)(Change in baseline SSEPs at 3 & 6 months)
- Motor Evoked Potentials (MEPs)(Change in baseline MEPs at 3 & 6 months)
- Functional Magnetic Resonance Imaging (fMRI)(Change in baseline functional connectivity at 3 & 6 months)
- Laboratorial Assessments (NTF-3)(Change in baseline NTF-3 at 3 & 6 months)
研究者
Julio Furlan, MD
Neurologist
University Health Network, Toronto