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临床试验/NCT04314960
NCT04314960Unknown不适用

Immediate and Long-term Effects of Gait Training With Functional Electrical Stimulation in Subjects With Chronic Ankle Instability

Shmuel Springer2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年6月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
试验地点
2
主要终点
Immediate change in ankle inversion angle during heel strike

研究概览

简要总结

Individuals with chronic ankle instability (CAI) display neuromuscular deficits such as altered control of posture and gait when compared with healthy controls. These deficits may be attributed to muscle inhibition occurring after a surrounding joint structure has been damaged. Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may overcome inhibition, and which is coupled with a functional task such as gait.

The current study aims to investigate the short and immediate effects of FES on gait parameters and postural control in subjects with CAI. Prior to intervention, treadmill gait will be evaluated using a motion analysis system, and postural control will be evaluated in a series of tests that measure balance, reaction time to ankle perturbation and stabilization ability after jump-landing. Then, a 20 minutes gait training with an FES device will be applied. Immediate effects of the training on gait parameters will be assessed. For medium-term effects evaluation, subjects will return for additional 7 training sessions (2 per week for 4 weeks), following by a complete measurements acquisition as prior to intervention. At six months follow-up, subjects will be contacted for collecting subjective outcomes.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A history of at least one significant ankle sprain:
  • At least 12 months prior to participating in the study
  • Was characterized by inflammatory symptoms (i.e. pain and swelling)
  • Caused at least one day of decreased physical activity
  • At least 3 months since the last acute ankle sprain that results in inflammatory symptoms and at least one interrupted day of desired physical activity.
  • History of the previously injured ankle 'giving way' at least twice during the last 6 months, and/or 'feelings of instability' and/or recurrent sprain.
  • Being able to bear full weight on the injured lower extremity with no more than mild discomfort.
  • Scoring<24 in the Cumberland Ankle Instability Tool (CAIT)

排除标准

  • A history of previous surgeries to a musculoskeletal structure in either lower limb.
  • A history of a fracture requiring re-alignment
  • Any acute injury to a lower limb in the last 3 months.

结局指标

主要结局

Immediate change in ankle inversion angle during heel strike

时间窗: immediately after the intervention

Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system. Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.

Change in peroneal muscle electromyography at 4 weeks

时间窗: through intervention completion, approximately at 4 weeks

Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike. Change will be measured between pre-intervention and after completing the entire intervention.

Immediate change in peroneal muscle electromyography

时间窗: immediately after the intervention

Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike. Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.

Change in ankle inversion angle during heel strike at 4 weeks

时间窗: through intervention completion, approximately at 4 weeks

Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system. Change will be measured between pre-intervention and after completing the entire intervention.

次要结局

  • Change in Star excursion balance test (SEBT) score(through intervention completion, approximately at 4 weeks)
  • Peroneal reaction time (PRT)(through intervention completion, approximately at 4 weeks)
  • Time to stabilization (TTS)(through intervention completion, approximately at 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shmuel Springer

Chair, Physiotherapy Department, Neuromuscular & Human Performance Laboratory

Ariel University

研究点 (2)

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