Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Gait Velocity
研究概览
简要总结
The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.
The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.
详细描述
Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.
In this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in the rehabilitation of the legs of participants with incomplete SCI.
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
- •Paraplegia or tetraplegia due to SCI
- •At least 1 year post incomplete Spinal Cord Injury
- •Can tolerate sitting upright for at least one hour
- •Capable of weight-bearing and taking a step with or without an assistive device
- •On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5 level
- •Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg
排除标准
- •Fracture of the treated limb resulting in loss of range of motion
- •Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study), or other neurological injury or disease
- •DVT of the treated extremity
- •Peripheral nerve injury of the treated extremity
- •Osteo- or rheumatoid-arthritis limiting range of motion
- •Contractures equal to or greater than 50% of the normal ROM
- •Skin condition not tolerant of device or sitting upright
- •Progressive neurodegenerative disorder
- •Botox treatment of the treated extremity in the prior 5 month
- •Chronic ITB therapy
- •Uncontrolled seizure disorder
- •Uncontrolled high blood pressure/angina
- •Pain in affected limb or exercise intolerance
- •Participation in another therapy or activity-based program
- •Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9
结局指标
主要结局
Gait Velocity
时间窗: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Measured by the GAITRite system
次要结局
- Timed 10-Meter Walk Test(Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).)
- Modified Ashworth Scale(Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).)
- Vibration Threshold Test(Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).)
- Gait Assessment Including Step Length and Cadence(Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).)
- Ankle Active Motion Test(Prior to each treatment session, on average 3 times a week)
- Ankle Strength(Prior to each treatment session, on average 3 times a week)
- ASIA Motor and Sensory Scores for L2-S1(Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).)
研究者
Paul J. Cordo
Study Principal Investigator
Oregon Health and Science University