Phase 1 Effects of Training With a Novel Rehabilitation Bike on the Functional Recovery and Corticospinal Plasticity in Individuals With Incomplete Spinal Cord Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Peak-to-peak amplitude of the motor evoked potentials (MEPs)
研究概览
简要总结
A novel rehabilitation bike has been developed for patients with incomplete spinal cord injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle strengthening has been reported by NASA to improve muscle atrophy in astronauts in zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict that the combination of mechanical stimulation with cycling may be similar enough to walking over ground to lead to gains in balance and mobility. The present study will evaluate the therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal pathways in patients with incomplete spinal cord injuries.
详细描述
INTRODUCTION:
Individuals with spinal cord injuries (SCI) experience balance impairments and limitations in walking. Newer research demonstrates that even after several years individuals with incomplete SCIs can make significant gains in function when they are engaged in targeted physical activity. Previous studies using functional electrical stimulation and locomotion training report reduced spasticity and reflex control, increased electromyography activity during stepping, and increased thigh muscles mass. However, these methods and instruments are bulky, expensive, need technical maintenance, and must be used in a clinical setting. A novel rehabilitation bicycle that uses simultaneous stimulation of plantar mechanoreceptors and hip joint proprioceptors was developed in the department of Biomedical Engineering of University of Manitoba. An advantage of this device is that patients can use it at home and with minimal assistance. Five patients completed initial pilot testing and exhibited an overall improvement on the Berg Balance Scale. Presently, the effect of rehabilitation bike training on the plasticity of the spinal and corticospinal neuronal circuitry and consequently its effects on the functional walking capacity are unclear.
OBJECTIVES:
The purpose of the present study is to evaluate the effect of the rehabilitation bike on corticospinal and spinal plasticity, and functional walking and balance in incomplete SCI individuals.
METHODS:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant should have experienced a traumatic spinal cord injury
- •American Spinal Injury Association (ASIA) class C or D
- •Between 18 and 65 years
- •At least 12 months post- injury to ensure stability of the patient's neurological condition
- •Should be able to walk 10 meters or more with or without assistance (use of braces or walking aids or parallel bars or moderate assistance of one person)
- •Should have range of motion in the lower limb joint sufficient to allow the cycling exercise
- •Discharged from all rehabilitation.
排除标准
- •Impaired mental capacity
- •Any medical contradiction to cycling training
- •Degenerative spinal disorder
- •Significant diagnosed osteoporosis
- •Excessive spasticity in the legs as measured by a score of more than 3 on the Modified Ashworth Scale or any spasticity that limits the possibility of cycling exercise or walking
- •Obstructive and/or restrictive pulmonary disease
- •Severe spinal and Lower Limb deformities
- •Decubitus ulcer in the area in contact with the bike and bike's bed
结局指标
主要结局
Change in Peak-to-peak amplitude of the motor evoked potentials (MEPs)
时间窗: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
MEPs in tibialis anterior muscle using single pulse transcranial magnetic stimulation will be measure.The average of 4 trials in different stimulation intensity will be calculated.
Change in Peak-to-peak amplitude of the H-reflex
时间窗: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Average of 10 peak to peak amplitudes of the H-reflex in soleus muscle with stimulation frequencies of 0.1, 0.2, 0.5 and 10 Hz.
次要结局
- Change in Berg Balance Scale score(BBS)(2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session)
- Change in 2 minute walk test score(2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session)
- Change in Walking index for spinal cord injury (WISCI II) score(2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session)
- Change in 10 meter walk test time(2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session)
研究者
Dr. Cheryl Glazebrook
Associate Professor
University of Manitoba