Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Lean-and-release test
研究概览
简要总结
Up to 25 individuals living with chronic incomplete spinal cord injury (iSCI) who can stand but have limited ability to elicit a step without physical assistance or upper limb (U/L) support will be recruited for this study. The first objective of the study will aim to investigate the orthotic effect (i.e., immediate effect) of FES on the reactive stepping response. The second objective is to investigate the therapeutic effect of a novel balance intervention, perturbation-based balance training (PBT) combined with FES (i.e., PBT+FES) on reactive stepping ability, measures of postural sway during quiet standing (i.e., biomechanical measures), and scores on clinical measures of balance and walking.
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
- •have a motor incomplete SCI (i.e., AIS grade C or D) that is non-progressive;
- •be at least one year post-injury (i.e., chronic injury);
- •≥ 18 years old;
- •be able to stand independently for 60 sec;
- •unable to take a step bilaterally without physical assistance or upper extremity support;
- •able to understand spoken English;
- •free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke);
- •be able to provide informed, written consent.
排除标准
- •Contraindications for EMS. Electrical stimulation will not be used if:
- •it will be applied to areas where it could cause malfunction of electronic devices, including cardiac pacemakers;
- •a woman is pregnant;
- •the applied region has known or suspected malignancy;
- •the person has active deep vein thrombosis or thrombophlebitis;
- •there are active bleeding tissues, or the person has untreated hemorrhagic disorders;
- •there are infected tissues, tuberculosis, or wounds with underlying osteomyelitis;
- •tissues have been radiated in the past six months;
- •there are damaged skin areas or at-risk skin areas that would result in uneven conduction of current;
- •severe spasticity is present in the legs;
- •the person has contractures in the lower limbs that prevent achieving a neutral hip and ankle position, or extended knee;
- •there is a history of prior lower limbs fragility fracture;
- •the leg muscles are unresponsive to electrical stimulation (i.e., peripheral nerve damage in the legs).
- •Pressure sores on pelvis or trunk, where safety harness will be donned.
结局指标
主要结局
Lean-and-release test
时间窗: Up to 7 weeks
Test of reactive stepping and balance in the forward direction
Biomechanical measures of postural control
时间窗: Up to 7 weeks
Measurement of centre of pressure during quiet standing
次要结局
- Falls Efficacy Scale International(Up to 7 weeks)
- Activities-specific Balance Confidence Scale(Up to 7 weeks)
- Semi-structured interview(3 months post)
- Mini-Balance Evaluation Systems Test(Up to 7 weeks)
- Gait parameters(Up to 7 weeks)