ClinicalTrials.gg
Status unknownNCT03484169Updated Apr 3, 2018

Effects of Pelvic Patterns of Proprioceptive Neuromuscular Facilitation in the Pelvic Floor Muscles

An interventional study of intervention group in Motor Activity, sponsored by Universidade Federal de Pernambuco. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-03.

Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 350 studies in Motor Activity with a site in Brazil — 41 open to participants now, 52 under way, none of them phase 3. Motor Activity · Brazil.

Planned enrollment
228th of 328
30 · median 44
Started
2018
with 29 others
No phase
296 of 350
37 open now
Registered
203rd of 350
by date

Among the 350 studies in Motor Activity with a site in Brazil, this one is the 228th largest by planned enrollment of the 328 interventional ones that give a count, is one of 30 that started in 2018, is one of 296 with no phase, and was the 203rd registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

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Open to participants now

41 of the 350 studies in Motor Activity with a site in Brazil are open now. Recruiting first, the newest first:

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A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 35 Years · female · healthy volunteers too.

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02

Study summary

Specific patterns of PNF have been used in neurological and rheumatologic rehabilitation to improve trunk control and postural stability. However, there are no studies that analyze the effect of pelvic PNF patterns on pelvic floor muscles. We hypothesize that pelvic patterns of proprioceptive neuromuscular facilitation activate the pelvic floor muscles in healthy individuals through the abdomino-pelvic synergism. Thus, the objective of the study is to analyze the effects of pelvic patterns PNF on the recruitment of pelvic floor muscles in healthy individuals.

Read the detailed description

The project will address three aspects: a) analyze the activation of the deep pelvic floor muscles during the application of pelvic PNF patterns through electromyographic measurements; b) verify which diagonals of these pelvic patterns have a better effect on the recruitment of these muscle fibers; c) to analyze electromyographic activity after motor learning (repeated training of 12 sessions).

Study Design: Randomized controlled trial.

Sample: Will be part of the study 70 healthy women at menacme, eutrophic, nulliparous and aged between 18 and 35 years, recruited among students of the Department of Physical Therapy of the Federal University of Pernambuco. The initial sample will be divided into two groups: intervention group (GI) and one control group (CG), randomized through www.randomization.com by a researcher who will be blind regarding outcomes. The result of the randomization will be placed in sealed and opaque envelopes and the information will be revealed to the member in charge of the training only at the moment the intervention is performed, guaranteeing the secrecy of the allocation. The study will be triple blind, since the randomization and allocation of participants will be performed by researcher A, electromyographic evaluations, data tabulation and statistical analysis (researcher B) and intervention (researcher C). After the initial analysis, the sample calculation will be performed using GPower software version 3.1.

Methodological outline:

Three researchers (A, B and C) will be part of the study data collection. After the clear explanation of the procedures that will be carried out during the research and the application of the Informed Consent Form (TCLE), the individuals will be subjected to a screening to analyze the eligibility. Initially, a semistructured form will be used to collect data that may be important during the analysis of the results, such as personal and sociodemographic data, anthropometric characteristics, associated diseases, medication use and gynecological history. Afterwards, the Female Sexual Function Index (FSFI) will be applied to evaluate the sexual function of the participants, translated and validated for use in Brazil.

After the application of the semistructured form, the volunteers will be submitted to a postural evaluation using photogrammetry and, physical examination for functional evaluation of the pelvic floor muscles, using the PERFECT protocol.

Finally, the electromyographic activity of the pelvic floor and abdominal muscles will be recorded during the performance of the pelvic patterns of PNF with active and resisted movements.

Recording of the electromyographic signal:

Surface electromyography will be performed during the application of pelvic PNF patterns and when associated with an active contraction of the MAP. For that, self-adhesive surface electrodes, simple and low impedance MAXICOR medical products (Paraná, Brazil), positioned in the abdominal region and pelvic floor, will be used. Owing to the rules for the acquisition of the electromyographic signal, standardized by the International Society of Electrophysiology and Kinesiology (ISEK), low-impedance surface circular electrodes (25mm diameter), self-adhesive (solid cellulose gel) and disposable surface electrodes will be used. To eliminate external interferences, a reference electrode positioned on the right anterior superior iliac spine (EIAS) will be used following the recommendations of the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) Project. To minimize noise, recording and capture devices will only be connected to the battery during data collection. In order to reduce the impedance of the skin, the area will be cleaned to be positioned the electrodes using moist wipes, drying it just before registration. Also, to reduce the impedance of the skin, the tricotomy of the area where the electrode will be positioned before data collection will be requested, as well as the bladder emptying before the procedures. The electromyographic recording will be performed with the patient in left lateral decubitus during the application of pelvic PNF patterns. The general guidelines for the positioning of the electrodes described by SENIAM will be followed, however, the muscles analyzed are not included in their specific electrode placement recommendations. Therefore, to capture the electromyographic signal will be positioned along the line of action of muscle fibers, always choosing the right side of the individual, in the following anatomical structures:

  • Transverse abdominal / internal oblique muscle group: surface electrode positioned 2 cm proximal to the midpoint between the pubic symphysis and the anterior superior iliac spine (EIAS).
  • Lumbar square muscle: surface electrode positioned 4 cm lateral, based on the vertebral sulcus of the muscle belly of the erector muscle of the spine with slightly oblique angulation at half the distance between the 12th rib and the iliac crest.
  • Thigh adductor group: upper middle third in the midline of the thigh.
  • Pelvic floor muscles: in the supine position, the surface electrodes will be positioned at the three and nine o'clock position of the perineal clock.

The acquisition will be performed outside of the menstrual period and three maximal voluntary contractions (CVM) of each muscle or muscle group evaluated will be requested to obtain the highest activity during standardized tests (AEMP RMS). It will be requested the maximum contraction that the participant can perform and each contraction being sustained for 3 seconds, with interval of 30 seconds between each contraction.

After the acquisition of the AEMP RMS registry, the registry will be performed during the execution of the four isolated pelvic patterns (RMS AEMFNPI) and later when associated with pelvic floor muscle contraction (RMS AEMFNPA).

To acquire the electromyographic signal, a Miotec® surface electromyograph (Miotool 400 model, Miotec Equipamentos Biomédicos Ltd. Porto Alegre, Brazil) will be used with four channels and 14-bit analogue / digital (A / D) resolution, with internal gain of 1000 times. The sampling frequency per channel used will be 2000 Hz, 110 dB common mode rejection (CMRR), 1010 Ohm // 2pF input impedance, and fourth order Butterworth analog filter. The captured signal will be recorded using the Miotec Suite Software version 1.0 (Miotec®, Porto Alegre, Brazil) and transferred to a portable computer.

Proprioceptive Neuromuscular Facilitation Protocol:

The pelvic movements that originate the patterns are: Anterior Elevation (EA); Posterior Depression (PD); Posterior Elevation (EP) and Anterior Depression (AD) of the pelvis, totaling four specific pelvic patterns and two diagonals [anterior elevation and posterior depression (Diagonal 1) and posterior Elevation and anterior depression (Diagonal 2)] In this study, the performance of the pelvic patterns, accompanied by the electromyographic signal capture, will be performed after learning the technique done through rhythmic initiation. After learning each pattern, electromyographic recording will be performed using the specific isotonic combination technique, which combines concentric, eccentric and stabilizing contractions of the agonist muscle group without relaxation.

The protocol will be divided into four stages:

  1. st stage: Initial recording of the electromyographic signal during the execution of pelvic PNF patterns.

    The electromyographic signal (RMS AEMFNPI) during the four pelvic patterns: anterior elevation, posterior elevation, anterior depression and posterior depression will be made as the lateral decubitus individual and in each muscle or muscle group evaluated during the execution of the combination technique isotonic in each pattern. The electromyographic recording of the abdominal and pelvic floor muscles will be done three times to perform the weighted average in the following sequences:

    Combination of isotonic (concentric, stabilizing and eccentric) of the anterior elevation pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior depression pattern ; Combination of isotonic (concentric, stabilizing and eccentric) of the previous depression pattern ; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior elevation pattern ;

  2. nd stage: Electromyographic evaluation during a maximal voluntary contraction of each muscle or muscle group evaluated.

Participants will undergo a preparatory training to awareness of the correct contraction of the pelvic floor muscles with the guidance of a pelvic physiotherapist and later electromyographic recording (AEMP RMS) during a maximal voluntary contraction of the pelvic floor muscles as well as of the abdominal muscles, adductors of the thigh and lumbar square through the standardized tests. In order to reduce the activity of the accessory musculature during the capture of the electromyographic signal of the MAP, the individual will adopt dorsal decubitus posture with flexion and external hip rotation and knee flexion, simulating the frog posture of the Global Posture Reeducation (RPG) technique.

Stage 3: Intervention - Motor skills training The training of the pelvic PNF patterns for motor learning in the GI will be performed twice a week by a trained and experienced researcher for six weeks. At each training session, there will be three repeated movements in each pelvic pattern.

4th stage: Re-evaluation of electromyographic activity after intervention. In this stage, an electromyographic reassessment of the two groups (GI and GC) after the training period will be performed, following the same sequences of step 1 (isolated recording during the execution of the pelvic standards) and step 3 (recording during the execution of the associated pelvic patterns to the voluntary contraction of MAPs.

03

Conditions studied

  • Motor Activity

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Keywords

  • Muscle Stretching Exercises
  • Pelvic Floor
  • motor control
  • motor skill
  • motor activity
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • female individuals
  • aged between 18 and 35 years
  • healthy at menacme, eutrophic, nulliparous
  • functional evaluation of pelvic floor muscles presenting muscular strength ≥3 of the Oxford Scale.

Exclusion criteria

Exclusion Criteria:

  • Pregnant women will be excluded from the study;
  • women with a history of previous abdominal and / or pelvic surgeries;
  • urogynecological and neuromuscular diseases;
  • vaginismus;
  • increased perineal muscle tone;
  • chronic constipation;
  • diabetes;
  • connective tissue disease;
  • anal fissures;
  • active hemorrhoids; (chronic pelvic pain, pyriform syndrome, hyperlordosis or marked lumbar rectification)
  • smokers.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Control group

    No intervention

  • Experimental
    intervention group

    The training of PNF pelvic patterns for motor learning in GI will be performed twice a week by a trained and experienced researcher for six weeks (CHRISTIANSEN et al., 2017). At each training session, there will be three repeated movements in each pelvic pattern: Combination of isotonic (concentric, stabilizing and eccentric) of the anterior elevation pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the previous depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior elevation pattern;

    Other: intervention group

Interventions

  • Otherintervention group

    The training of PNF pelvic patterns for motor learning in GI will be performed twice a week by a trained and experienced researcher for six weeks (CHRISTIANSEN et al., 2017). At each training session, there will be three repeated movements in each pelvic pattern: Combination of isotonic (concentric, stabilizing and eccentric) of the anterior elevation pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the previous depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior elevation pattern;

    Also known as: pelvic pattern of proprioceptive neuromuscular facilitation

06

What researchers measure

Primary outcomes

  1. Electromyographic activation of pelvic floor muscles

    The electromyographic signal (RMS AEMFNPI) during the four pelvic patterns: anterior elevation, posterior elevation, anterior depression and posterior depression will be made as the lateral decubitus individual and in each muscle or muscle group evaluated during the execution of the combination technique isotonic in each pattern. The electromyographic recording of the abdominal and pelvic floor muscles will be done three times to perform the weighted average in the following sequences: Combination of isotonic (concentric, stabilizing and eccentric) of the anterior elevation pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the previous depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior elevation pattern;

    Time frame: one day

Secondary outcomes

  1. Motor learning after repetitive training of pelvic PNF patterns

    The training of PNF pelvic patterns for motor learning in GI will be performed twice a week by a trained and experienced researcher for six weeks (CHRISTIANSEN et al., 2017). At each training session, there will be three repeated movements in each pelvic pattern.

    Time frame: 6 weeks

Other outcomes

  1. Body Mass Index (BMI)

    weight and height will be combined to report BMI in Kg/m2

    Time frame: one day

  2. Sexual Function

    ordinal qualitative variable, which will be measured through the Female Sexual Function Index (FSFI). Score 26 will be used as the cut-off point for categorizing the variable, in which scores ≤ 26 indicate sexual dysfunction.

    Time frame: one day

  3. Strength of pelvic floor muscles

    a qualitative ordinal variable, which will be measured by the Oxford Scale, classified as: (0) Degree 0; (1) Grade 1; (2) Grade 2; (3) Grade 3; (4) Grade 4.

    Time frame: one day

  4. Postural change (pelvis)

    continuous quantitative variable, measured through angulation in degrees during photogrammetry.

    Time frame: one day

07

Study locations

1 of 1 sites recruiting
  • Josepha Karinne de Oliveira Ferro
    Recife, Pernambuco +5581, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Nov 2018, 8 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 8 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2018
First posted
Mar 30, 2018
StartActual
Mar 1, 2018
Primary completionEst.
Nov 30, 2018
CompletionEst.
Nov 30, 2019
Last update
Apr 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03484169
Responsible party
Josepha Karinne de Oliveira Ferro (PhD student, Universidade Federal de Pernambuco) — Principal investigator
First posted
Mar 30, 2018
Start date
Mar 1, 2018
Primary completion
Nov 30, 2018 (estimated)
Completion
Nov 30, 2019 (estimated)
Last update
Apr 3, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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