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Completed

NCT Number: NCT04661774

Specific Effect of Foot Reflexology on Diaphragm Function

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAYOUX

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Reflexology Massage

Other

reflexology massage of the foot zone implicated in diaphragm stimulation

Sham massage

Other

traditional massage of the foot

Primary outcomes

  1. modulation of brain activity of the specific impact of RP

    Time frame: 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

Secondary outcomes

  1. variation of physiological constants related to the function of the diaphragm

    Time frame: Day 1

    collection of respiratory rate

  2. variation of physiological constants related to the function of the diaphragm

    Time frame: Day 1

    collection of saturation

  3. variation in physiological constants linked to the ANS

    Time frame: Day 1

    collection of heart rate

  4. subjective feelings of the subjects

    Time frame: Day 1

    Likert scale for the subjective assessment of stress and a Likert scale for the subjective assessment of ease of breathing (graduations from 1 to 7 with 1 = I completely agree and 7= I Don't agree at all)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: FOOT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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