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临床试验/NCT04661774
NCT04661774已完成不适用

Specific Effect of Foot Reflexology on Diaphragm Function: Comparison Between Different Biomarkers Upon Stimulation of the Reflex Area

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1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
入组人数
30
试验地点
1
主要终点
modulation of brain activity of the specific impact of RP

研究概览

简要总结

Diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). The investigators proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

详细描述

Many complex, chronic and multifactorial dysfunctions, such as diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). This change is essential and will broaden relevant solutions to health.

Despite the very positive benefits of RP highlighted, the methodological quality of trials are often poor and there are gaps notably on the description of the intervention, the blind, the drop-out rate ... which prevents the meta-analyzes to conclude. Promoting rigorous research will play an essential role in the transition to personalized and integrative medicine. With the intention of specifying the methods of application and the indications of the PR, it is necessary to correctly evaluate and be able to cross-check the different information It therefore seems relevant to combine research on the objective physiological effects in correlation with the patient's subjective feelings to initiate the scientific validation of RP and thus non-drug interventions as recommended by the High Authority for Health (HAS). The hypothesis is that through a comparison of the evolution of different parameters, quantitative and qualitative, this study will allow to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

each participant has reflexology and placebo massage, he is his own comparator

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult aged 20 to 40
  • Healthy right-handed subject, attested by a score ≥ 8/10 on the Edinburgh manual laterality questionnaire
  • Naive subject in Reflexology.

排除标准

  • Contraindication to carrying out the MRI examination
  • Subject refusing to be informed of any abnormality detected on brain MRI,
  • Subject presenting a neurodegenerative disease,
  • Subject presenting a cardiac disease,
  • Subject presenting skin lesions in the feet or recent fracture in the feet,
  • Subject having an history of phlebitis less than 3 months
  • Subject having an history of deep vein thrombosis.

研究组 & 干预措施

Reflexology massage (RP) before Sham massage

Other

RP will be realized before Sham massage.

干预措施: reflexology massage (Other)

Reflexology massage (RP) before Sham massage

Other

RP will be realized before Sham massage.

干预措施: sham massage (Other)

Sham massage before reflexology massage (RP)

Other

Sham massage (MS) comparator will be realised before RP.

干预措施: reflexology massage (Other)

Sham massage before reflexology massage (RP)

Other

Sham massage (MS) comparator will be realised before RP.

干预措施: sham massage (Other)

结局指标

主要结局

modulation of brain activity of the specific impact of RP

时间窗: day 1

a comparison between the activation cards of the brain networks and a map of correlation coefficients representing the strength of the connectivity between the different brain networks and regions of interest

次要结局

  • variation of physiological constants related to the function of the diaphragm(Day 1)
  • variation in physiological constants linked to the ANS(Day 1)
  • subjective feelings of the subjects(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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