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Motor ActivityNCT03484169

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

A study testing intervention group in people with Motor Activity, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Motor Activity
What is being tested?
intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
1 Mar 2018to 30 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • diabetes;
  • connective tissue disease;
  • anal fissures;
  • active hemorrhoids; (chronic pelvic pain, pyriform syndrome, hyperlordosis or marked lumbar rectification)
  • smokers.

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting
  • Josepha Karinne de Oliveira Ferro

    Recife, Pernambuco, +5581

    Josepha KO Ferro, Master, +5581998058006, karinneferro@gmail.com

    Recruiting

Other trials in Brazil

About this study

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.

Conditions
Motor Activity
Being tested
intervention group
Keywords
Muscle Stretching Exercises, Pelvic Floor, motor control, motor skill, motor activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intervention groupOther

    Also called pelvic pattern of proprioceptive neuromuscular facilitation

    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;

Study groups in NCT03484169
Study groupRoleWhat they receive
Control groupNo interventionNo intervention
intervention groupExperimentalThe 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;
Receives: Other: intervention group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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;

    Measured: one day

Secondary outcomes (1)
  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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start1 Mar 2018
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion30 Nov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Will be part of the study 30 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 n=15 (GI) and one control group n=15 (CG), randomized through www.randomization.com by a researcher who will be blind regarding outcomes.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484169
Sponsor's protocol ID
PNF in pelvic floor muscles
Status last verified
Mar 2018
First submitted
16 Mar 2018
Last updated
3 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing intervention group in people with Motor Activity, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electromyographic activation of pelvic floor muscles (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.

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