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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06090435
Other study ID # UV0002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date April 30, 2024

Study information

Verified date October 2023
Source University of Valencia
Contact Ferran Cuenca Martínez, PhD
Phone 913456780
Email ferran.cuenca@uv.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Both motor imagery and action observation training, either alone or in combination with physical practice, have been shown to improve some clinical variables of interest such as strength and motor control. However, this has not yet been investigated in the pelvic floor musculature.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Therapeutic exercise plus motor imagery
Therapeutic exercise programme (aerobic exercise and strengthening exercise) to which is added a motor imagery intervention (which consists of imagining the same movements but not performing them for real).
Therapeutic exercise plus action observation
Therapeutic exercise programme (aerobic exercise and strengthening exercise) to which is added an action observation intervention (which consists of observing the same movements but not performing them for real).
Therapeutic exercise
Therapeutic exercise programme (aerobic exercise and strengthening exercise) to which is added a sham action observation intervention (which consists of observing planets in space).

Locations

Country Name City State
Spain Ferran Cuenca Martínez Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximal pelvic floor muscle strength (measured in grams and with the phenix device) 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), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).
Primary Algometry for assessing pressure pain thresholds (Pain sensitivity) An algometer shall be used to assess pain thresholds to pressure, i.e. squeezing so that pressure is converted into pain at four points. Two points in the symphysis pubis area, one point in the lumbar area and one point near the tibial tuberosity. pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).
Primary Motor control of the lumbopelvic area assessed with a biofeedback device. A protocol to assess lumbopelvic dissociation (i.e. moving the legs without moving the lower back) of both legs of the participants will be performed with a biofeedback device that assesses the pressure exerted on the lower back during leg mobilisation (in mmHg). pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).
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