Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women

Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Motor Imagery; Therapeutic Exercise; Action Observation
• Intervention / Treatment: Behavioral: Therapeutic exercise plus motor imagery; Behavioral: Therapeutic exercise plus action observation; Behavioral: Therapeutic exercise

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ferran Cuenca Martínez, PhD; Phone Number: 913456780; Email: ferran.cuenca@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46017
    • Recruiting
    • Ferran Cuenca Martínez
    • Contact: Ferran Cuenca Martinez, PhD; Phone Number: 913456781; Email: ferran.cuenca@uv.es

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)).

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: UV0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No