FES Driven Stepping in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
研究概览
简要总结
The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes.
详细描述
Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. The FES stepping in this study will be done through a device called the RT600 FES Stepper (RT600).
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
- •Male, Female, age 18-65, all ethnic groups
- •Spinal Cord Injury, traumatic and non-traumatic
- •C1-T12 neurological level
- •ASIA class A-D
- •Chronic injury > 6 months from the injury
- •Visible motor response to FES stimulation (visible muscle contraction evoked with electrical stimulation)
- •Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- •Subjects are able to comply with procedures and follow-up
排除标准
- •Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- •History of inability to tolerate electrical stimulation
- •Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability
- •Uncontrolled hypertension (resting systolic BP > 160mmHg or diastolic BP >100mmHg consistently)
- •Presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices other than baclofen pumps
- •Unstable long bone fractures of the lower extremities
- •Presence of stage III or greater skin ulcerations that would preclude application of stimulating pads
- •Malignancy
- •History of epileptic seizures
- •Women who are pregnant
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- •Fractures less than 6 months
结局指标
主要结局
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
时间窗: Baseline, 8 weeks
Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal.
次要结局
- Change in Systolic Blood Pressure(Baseline, 8 weeks)
- Change in Diastolic Plood Pressure(Baseline, 8 weeks)
- Change in Rate of Perceived Exertion(Baseline, 8 weeks)
- Change in Vital Capacity(Baseline, 8 weeks)
- Change in Peak Cough Flow(Baseline, 8 weeks)
- Change in Heart Rate(Baseline, 8 weeks)
研究者
Cristina Sadowsky, M.D.
Assistant Professor Physical Medicine and Rehabilitation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.