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临床试验/NCT03484169
NCT03484169Unknown不适用

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

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Electromyographic activation of pelvic floor muscles

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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).

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

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;

干预措施: intervention group (Other)

结局指标

主要结局

Electromyographic activation of pelvic floor muscles

时间窗: one day

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;

次要结局

  • Motor learning after repetitive training of pelvic PNF patterns(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josepha Karinne de Oliveira Ferro

PhD student

Universidade Federal de Pernambuco

研究点 (2)

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