NCT03484169

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 16, 2018

Last Update Submit

March 31, 2018

Conditions

Keywords

Muscle Stretching ExercisesPelvic Floormotor controlmotor skillmotor activity

Outcome Measures

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;

    one day

Secondary Outcomes (1)

  • Motor learning after repetitive training of pelvic PNF patterns

    6 weeks

Other Outcomes (4)

  • Body Mass Index (BMI)

    one day

  • Sexual Function

    one day

  • Strength of pelvic floor muscles

    one day

  • +1 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

No intervention

intervention group

EXPERIMENTAL

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

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
intervention group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Josepha Karinne de Oliveira Ferro

Recife, Pernambuco, +5581, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 30, 2018

Study Start

March 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2019

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations