A Pilot Randomized Controlled Study of the Effects of Exoskeleton Training on Neurogenic Bowel Dysfunction in Spinal Cord Injury/ Disease
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
- The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)
研究概览
简要总结
The purpose of the study is to assess the effects of exoskeleton training on neurogenic bowel disorders in spinal cord injury/ disease.
详细描述
After being informed about the study and the potential risks, all patients giving written consents will undergo a medical examination to ensure they are eligible and fit to proceed for the study. Subjects will be randomly assigned to intervention group and control group.
Intervention group will receive 2 consecutive courses of exoskeleton training (ET) with twelve 45-minute sessions, each to be completed in 6 to 8 weeks. The total period of training will be 12 to 16 weeks.
Control group will receive twelve 45-minute sessions of usual physiotherapy treatment (PT), consisting of maintenance exercise in the first 6 to 8 weeks, and then one course of ET with twelve 45-minute sessions in the following 6 to 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •SCI/D for a duration ≥ 12 months
- •Neurological level of injury (NLI) C4 to L3 as defined in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) 2019 revision
- •Bowel opening via anal route or stoma
- •Stable medical condition
- •Stable mental condition
- •No active painful musculoskeletal problems like fracture, infection, pressure injury, contracture or uncontrolled spasticity
- •Age ≥ 18 years old
- •Body height 150 - 188cm
排除标准
- •Unstable cardiovascular or pulmonary conditions
- •Untreated thromboembolic events
- •Untreated psychiatric disorders
- •History of malignancy
- •Any contra-indications for exoskeleton training
研究组 & 干预措施
Intervention
Subjects will receive 2 consecutive courses of exoskeleton training with twelve 45-minute sessions, each to be completed in 6 to 8 weeks. The total period of training will be 12 to 16 weeks.
干预措施: Exoskeleton training with Ekso NR (Device)
Control
Subjects will receive twelve 45-minute sessions of usual physiotherapy treatment, consisting of maintenance exercise in the first 6 to 8 weeks, and then one course of exoskeleton training with twelve 45-minute sessions in the following 6 to 8 weeks.
干预措施: Exoskeleton training with Ekso NR (Device)
结局指标
主要结局
The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)
时间窗: Week 0 (Pre-training), Week 8, , Week 16, week 24
Measurement of the change in the NBD score (0-45, 0-6 Very minor, 7-9 Minor, 10-13 Moderate and 14 or more Severe neurogenic bowel dysfunction) calculated in the data set.
次要结局
- The change in frequency of bowel incontinence episodes(Week 0 (Pre-training), Week 8, , Week 16, week 24)
- The change in defaecation time (DT)(Week 0 (Pre-training), Week 8, , Week 16, week 24)