Specific Effect of Foot Reflexology on Diaphragm Function
FOOT
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedMay 6, 2026
August 1, 2023
6 months
November 6, 2020
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modulation of brain activity of the specific impact of RP
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
day 1
Secondary Outcomes (4)
variation of physiological constants related to the function of the diaphragm
Day 1
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
Study Arms (2)
Sham massage before reflexology massage (RP)
OTHERSham massage (MS) comparator will be realised before RP.
Reflexology massage (RP) before Sham massage
OTHERRP will be realized before Sham massage.
Interventions
reflexology massage of the foot zone implicated in diaphragm stimulation
traditional massage of the foot
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PAYOUX
Toulouse, France
Related Publications (1)
Descamps E, Boussac M, Joineau K, Payoux P. Changes of cerebral functional connectivity induced by foot reflexology in a RCT. Sci Rep. 2023 Oct 10;13(1):17139. doi: 10.1038/s41598-023-44325-x.
PMID: 37816799RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- each participant has reflexology and placebo massage, he is his own comparator
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
December 10, 2020
Study Start
December 1, 2020
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
May 6, 2026
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share