Conventional-therapy & FES-therapy In-Veritas Effects Study (C-FIVE Study): Rehabilitation of the Upper Extremity for New Persistent C5 Palsy After Surgical Treatment of Patients With Degenerative Cervical Myelopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Spinal Cord Independence Measure (SCIM) score
研究概览
简要总结
This randomized clinical trial will primarily compare the effectiveness of conventional physiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy.
详细描述
This randomized clinical trial will primarily compare the effectiveness of conventionalphysiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy. Secondarily, this clinical trial will evaluate the effectiveness of combined conventional physiotherapy and FES-t along with task-specific training outcome compared to conventional physiotherapy alone with regards to improved connectivity andexcitability in the ascending and descending pathways as assessed using neurophysiological tests and functional MRI analysis.
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
- Single (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
- •New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy
排除标准
- •Contraindication for FES-t
- •Contraindication for neurophysiological testing
- •Contraindication for MRI scanning
- •Uncontrolled cardiovascular conditions
- •Other medical conditions that can limit treatment protocols
- •Other neurological diseases
- •Significant persisting mental illness
- •Diagnosed learning disabilities
- •Substance abuse over 6 months prior to recruitment
- •Hearing and visual deficits sufficient to affect test performance
- •Reduced passive range of motion (ROM) of the shoulder ("frozen shoulder")
- •Inability to participate in and intensive outpatient rehabilitation program
结局指标
主要结局
Change in Spinal Cord Independence Measure (SCIM) score
时间窗: up to 10 weeks post-intervention
The SCIM is a clinician-administered disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently (SCIM varies from 0 (completely dependent) to 100 (completely independent).
次要结局
- Change in neurophysiological parameters(up to 10 weeks post-intervention)
- change in Modified Japanese Outcome Association (mJOA) Score(up to 10 weeks post-intervention)
- Change in Functional Magnetic Resonance Imaging (MRI)(6 to10 weeks post-intervention)
- Change in Manual muscle testing(up to 10 weeks post-intervention)