Assessing the Usefulness of Functional Electrical Stimulation Program on Tibial Nerve for Rehabilitation of Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in gait velocity
研究概览
简要总结
Hemiparetic gait is one of the most common consequences after stroke. This impairment has a detrimental effects on the patients lies, limiting their social participation. Previous studies have shown that there is a direct relationship between triceps surae activation and gait speed in stroke patients, that is, higher triceps surae muscle activation are correspond to greater gait speed. Then, it can be hypothesized that therapies focused in strengthening the triceps surae also improves the patient gait. It has been shown that Functional Electrical Stimulation (FES) can improve triceps surae activation when applied on healthy subjects. However, it has not been yet explored in chronic stroke patients. Therefore, the aim of this study is to assess whether a FES program over tibial nerve contributes to the rehabilitation of the gait in chronic hemiparetic stroke patients. This study present a prospective interventional design, based on non-probabilistic sampling for convenience, and comprising a total of 15 volunteers with ischemic stroke of both genders and aged between 18 and 70 years old. Volunteers will be recruited from hospitals and private rehabilitation centres, and must be currently engaged in a conventional rehabilitation program. The study will consist of twenty-four sessions, with a frequency of three sessions per week.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging between 18 to 70 years.
- •Subjects with chronic ischemic stroke (more than 12 months of evolution)
- •Ability to walk 20 mts. without third-party assistance.
- •Hemiparesis with weakness and spasticity in the triceps surae.
排除标准
- •Previous injury on paretic lower limb
- •Soft tissue or joint retraction limiting ankle range of motion (ROM)
- •Severe peripheral nervous system compromise
- •Electronic devices that could be altered by the use of FES (e.g. cardiac pacemaker)
研究组 & 干预措施
FES program
干预措施: FES program (Other)
结局指标
主要结局
Change in gait velocity
时间窗: Baseline and week 8 (after 24 sessions of intervention)
A 10 metres walk test will be performed to asses gait velocity.
次要结局
- Changes in stride length(Baseline and week 8 (after 24 sessions of intervention))
- Change in Spasticity(Baseline, immediately after first session and week 8 (after 24 sessions of intervention))
- Change in cortical electrical activity(Baseline and week 8 (after 24 sessions of intervention))
- Change in muscle activity(Baseline, immediately after first session and week 8 (after 24 sessions of intervention))
- Change in swing phase(Baseline and week 8 (after 24 sessions of intervention))
- Change in stance phase(Baseline and week 8 (after 24 sessions of intervention))
- Change in double support(Baseline and week 8 (after 24 sessions of intervention))
- Change in spasticity(Baseline, immediately after first session and week 8 (after 24 sessions of intervention))
- Change in maximal isometric strength(Baseline, immediately after first session and week 8 (after 24 sessions of intervention))
- Changes in cadence(Baseline and week 8 (after 24 sessions of intervention))
- Change in stride time(Baseline and week 8 (after 24 sessions of intervention))
- Change in stride velocity(Baseline and week 8 (after 24 sessions of intervention))
研究者
Melisa Taborda
Principal Investigator
University of Gran Rosario
