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临床试验/NCT06082297
NCT06082297已完成不适用

Can Blood Flow Enhancing Plantar Flexion Electrically Induced Via Textile Electrodes in a Sock Using 1 Hz Frequency Give Better Comfort and Energy Efficiency as Compared to 36 Hz ?

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年7月17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
1
主要终点
Average duration of blood pulse (ADBP)

研究概览

简要总结

Muscle contractions induced by calf low-intensity neuromuscular electrical stimulation (C-LI-NMES) can increase venous return and may reduce venous thromboembolism. This study aimed to compare the effect of different C-LI-NMES frequencies and plateau times on hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse textile electrodes.

详细描述

Fifteen healthy participants were stimulated via two 3x3cm transverse textile electrodes integrated in a sock, with ten different combinations of frequency (1Hz or 36Hz) and plateau times (0.5/1.5/3/5/7s), with gradually increasing NMES-intensity until plantar flexion-induction. At this point, popliteal peak venous velocity (PVV), time-averaged mean velocity (TAMV) and ejection volume (EV) were assessed by Doppler-ultrasound, discomfort by a numerical rating scale (NRS, 0-10) and values for current amplitude and energy were calculated based on the NMES-device´s intensity level. Values expressed with median (interquartile range), significance set to p<0.05.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Basic Science
盲法
None

盲法说明

Participants did not receive information about what parameter-settings that were used for the different tests.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-99 years of age
  • •Voluntary participation

排除标准

  • •Pregnancy
  • •Pacemaker
  • •Ongoing thromboprophylaxis
  • •Skin wounds
  • •Vascular abnormalities
  • •Previous vascular system surgery in the lower limbs

研究组 & 干预措施

Single arm where repeated measures where performed in 15 participants.

Experimental

Each of the 15 participants in the arm was, in addition to the resting state (no intervention), exposed to 10 different interventions repeated after each other to enable repeated measures of the outcomes.

干预措施: Chattanooga Physio, DJO, neuromuscular electrical stimulation (Device)

结局指标

主要结局

Average duration of blood pulse (ADBP)

时间窗: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

Average duration of blood pulse will be assesed by Doppler ultrasound in the popliteal vein (seconds)

Time averaged mean velocity (TAMV)

时间窗: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

Time averaged mean velocity will be assesed by Doppler ultrasound in the popliteal vein (centimeters per second)

Ejection volume (EV)

时间窗: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

Ejection volume of blood will be assesed by Doppler ultrasound in the popliteal vein (milliliters)

Peak venous velocity (PVV)

时间窗: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

Peak venous velocity (centimeters per second) will be assesed by Doppler ultrasound of in the popliteal vein

次要结局

  • Current amplitude(Day 1 during ankle plantar flexion was induced by the intervention)
  • Numerical rating scale (NRS)(Day 1 during ankle plantar flexion was induced by the intervention)
  • Energy(Day 1 during ankle plantar flexion was induced by the intervention)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Ackermann

Professor,MD,PhD

Karolinska University Hospital

研究点 (1)

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