- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06323941
Motor Imagery and Isometric Exercises on Pelvic Floor Sensorimotor Condition
March 21, 2024 updated by: Ferran Cuenca, University of Valencia
Effects of Motor Imagery on Skin Conductance and Pelvic Floor Sensorimotor Condition in Healthy Women: A Randomized Controlled Trial
Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health.
Through the present study the investigators want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Valencia, Spain, 46017
- Ferran Cuenca Martínez
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Over 18 years of age and asymptomatic women.
Exclusion Criteria:
- This study will exclude those who presented a respiratory pathology, cardiac, systematic, or metabolic disease, history of recent surgery, vertebral fracture, or osteoarticular disorders of the spine area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor Imagery plus Isometric Exercise
This group will perform a therapeutic exercise programme (isometric exercises training) to which motor imagery training will be added.
|
Isometric exercises (20 minutes) to which will be added a motor imagery intervention (imagining movements without actually doing them).
|
|
Active Comparator: Isometric Exercise
This group will perform a therapeutic exercise programme (isometric exercises training) to which sham motor imagery training will be added.
|
Isometric exercises (20 minutes) to which will be added a placebo motor imagery intervention (imagining a blue sky).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin conductance (for asessing electrodermal activity)
Time Frame: pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)
|
skin conductance is a measure of sweating which is an excitatory sympathetic monoinervative variable.
|
pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Algometry for assessing pressure pain thresholds (Pain sensitivity)
Time Frame: pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)
|
An algometer shall be used to assess pain thresholds to pressure, i.e. squeezing so that pressure is converted into pain at two points.
One point in the symphysis pubis area, and one point near the tibial tuberosity
|
pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)
|
|
maximal pelvic floor muscle strength (measured in grams and with the phenix device)
Time Frame: pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)
|
Three measurements of maximal pelvic floor strength shall be performed with an intracavitary probe and the mean of the three measurements of maximal pelvic floor muscle strength shall be considered.
|
pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
March 14, 2024
Study Registration Dates
First Submitted
March 14, 2024
First Submitted That Met QC Criteria
March 14, 2024
First Posted (Actual)
March 21, 2024
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- UV0003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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