Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
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
Study Start
First participant enrolled
September 30, 2023
CompletedFirst Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedOctober 19, 2023
October 1, 2023
7 months
October 3, 2023
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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)).
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)).
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)).
Study Arms (3)
Therapeutic exercise plus motor imagery
EXPERIMENTALTherapeutic exercise plus action observation
EXPERIMENTALTherapeutic exercise
ACTIVE COMPARATORInterventions
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 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 programme (aerobic exercise and strengthening exercise) to which is added a sham action observation intervention (which consists of observing planets in space).
Eligibility Criteria
You may qualify if:
- Over 18 years of age and asymptomatic women.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ferran Cuenca Martínez
Valencia, 46017, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 19, 2023
Study Start
September 30, 2023
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
October 19, 2023
Record last verified: 2023-10