NCT03137108已完成不适用
Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control, Standing, and Overground Walking in Individuals With Incomplete Spinal Cord Injury Single Centre Pilot Study Investigating Immediate Effects of Transcutaneous Electrical Spinal Cord Stimulation on Voluntary Ankle and Knee Control, Standing and Overground Walking in Incomplete Spinal Cord Injury
适应症
干预措施
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
- Kinematic movement characteristics recorded with a motion capture system;
研究概览
简要总结
Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been developed. It was suggested, that this method could be used to improve the therapy process after a spinal cord injury (SCI). The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with incomplete SCI
- •Chronic (≥ 12 months post-injury) or subacute (≥ 3 months post-injury) stage of recovery
- •Age: ≥18 years
- •Able to complete the 10mWT with walking aids as required but no physical assistance
- •Neurological level of SCI: above T12
- •Preserved segmental and cutaneo-muscular reflexes in the lower limbs
- •Bodyweight > 20 kg and < 120 kg
- •Mini-Mental state examination score 6 (test only performed if cognitive deficits are suspected)
排除标准
- •Any other neurological diseases
- •Current orthopedic problems
- •Premorbid major depression or psychosis
- •History of significant autonomic dysreflexia with treatment
- •Dermatological issues (e.g. decubitus) at the stimulation or harness attachment site (back, abdomen, upper legs)
- •Active implants (e.g. cardiac pacemaker, implanted drug pump)
- •Passive implants at vertebral level T9 or more caudal vertebrae (metal screws and plates for surgical stabilization of spinal fractures)
- •Malignant diseases
- •Heart insufficiency NYHA III-IV
- •Potential pregnancy (pregnancy test must be conducted before each session)
- •Unlikely to complete the intervention or return for follow-up
- •Participation in another training study
- •Contraindications for BWS training using the FLOAT (according the manual):
- •No responsiveness
- •Severe muscle contractures
- •Acute fractures
- •Osteoporosis or osteogenesis imperfecta
- •Body size shorter than 1 meter or taller than 2 meters
研究组 & 干预措施
Incomplete Spinal cord injury
Experimental
干预措施: Transcutaneous electrical spinal cord stimulation (Device)
结局指标
主要结局
Kinematic movement characteristics recorded with a motion capture system;
时间窗: Baseline and intervention of a specific task will be assessed directly after each other in a single session. All movement tasks will be split into 2 sessions within 2 weeks. The start of the first session is variable.
次要结局
未报告次要终点
研究者
研究点 (1)
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