跳至主要内容
临床试验/NCT05240716
NCT05240716已完成不适用

Assessing the Usefulness of Functional Electrical Stimulation Program on Tibial Nerve for Rehabilitation of Chronic Stroke Patients

University of Gran Rosario2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年3月21日最近更新:
适应症
干预措施

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

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

Experimental

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

发起方
University of Gran Rosario
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melisa Taborda

Principal Investigator

University of Gran Rosario

研究点 (2)

Loading locations...

相似试验

Functional Electrical Stimulation on Tibial Nerve in... | 临床试验