Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- the Neuromuscular Recovery Scale (NRS)
研究概览
简要总结
So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old, with an incomplete or complete SCI/D of ≥ 3months, medically stable.
- •be recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community.
排除标准
- •adults with MRI contra-indications (stabilizing hardware is typically MRI safe);
- •adults with uncontrolled seizure disorder;
- •adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning;
- •adults with with ventilator dependency;
- •adults with other major medical complications
- •pregnant women
结局指标
主要结局
the Neuromuscular Recovery Scale (NRS)
时间窗: 12 weeks
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
The SCI-FI/AT
时间窗: 12 weeks
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
时间窗: 12 weeks
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
次要结局
未报告次要终点