The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
研究概览
简要总结
Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.
详细描述
Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. In this pilot study, we will investigate the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.
Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of iCycle training. Function will be assessed before and after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •using a wheelchair for at least two hours per day
排除标准
- •cardiac pacemaker
- •pressure sores or unresolved skin problems
- •unhealed lower limb fractures
- •active heterotrophic ossification (lower limbs)
- •severe osteoporosis
- •complex regional pain syndrome
- •metal implants near electrode sites
- •lower limb malignancy
- •T6 and below spinal malignancy
- •uncontrolled autonomic dysreflexia
- •history of knee dislocation/subluxation
- •allergy to electrodes
- •cognitive difficulties
- •severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or
- •neurological degenerative diseases.
研究组 & 干预措施
intervention
FES
干预措施: FES (Device)
结局指标
主要结局
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
时间窗: Change between baseline and 8 weeks
Neurological Classification
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
时间窗: Change between baseline and 4 weeks
Neurological Classification
次要结局
- Oxford scale motor power grading(Change between baseline and 8 weeks)
- Modified Ashworth Score (MAS)(Change between baseline and 8 weeks)
- Spinal Cord Independence Measure (SCIM)(Change between baseline and 8 weeks)
- Walking Index for Spinal Cord Injury (WISCI II)(Change between baseline and 8 weeks)
- Oxford scale motor power grading(Change between baseline and 4 weeks)
- Modified Ashworth Score (MAS)(Change between baseline and 4 weeks)
- Spinal Cord Independence Measure (SCIM)(Change between baseline and 4 weeks)
- Walking Index for Spinal Cord Injury (WISCI II)(Change between baseline and 4 weeks)
研究者
Jane Burridge, PhD
Professor of Restorative Neuroscience
University of Southampton