Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women

Sponsor
University of Valencia (Other)
Overall Status
Recruiting
CT.gov ID
NCT06090435
Collaborator
(none)
45
1
3
7
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Therapeutic exercise plus motor imagery
  • Behavioral: Therapeutic exercise plus action observation
  • Behavioral: Therapeutic exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women: A Randomized Controlled Trial
Actual Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapeutic exercise plus motor imagery

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).

Experimental: Therapeutic exercise plus action observation

Behavioral: 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).

Active Comparator: Therapeutic exercise

Behavioral: 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).

Outcome Measures

Primary Outcome Measures

  1. maximal pelvic floor muscle strength (measured in grams and with the phenix device) [pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).]

    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.

  2. Algometry for assessing pressure pain thresholds (Pain sensitivity) [pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).]

    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.

  3. Motor control of the lumbopelvic area assessed with a biofeedback device. [pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ferran Cuenca Martínez Valencia Spain 46017

Sponsors and Collaborators

  • University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ferran Cuenca, Principal investigator, University of Valencia
ClinicalTrials.gov Identifier:
NCT06090435
Other Study ID Numbers:
  • UV0002
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 19, 2023