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Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome

Primary Purpose

Pelvic Floor Muscle Syndrome

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
doing strengthening exercises of pelvic floor muscles
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Floor Muscle Syndrome focused on measuring Ankle positions, pelvic floor muscles strength, relaxation of pelvic floor muscles syndrome, doing strengthening exercises of pelvic floor muscles

Eligibility Criteria

25 Years - 55 Years (Adult)Female

Inclusion Criteria:

  • age 25-55
  • bma 20-30
  • women with relaxation of pelvic floor muscles syndrome in ph.ex and inspection

Exclusion Criteria:

  • severe deformity in knee joint and ankle
  • regular exercise or yoga
  • severe or moderate vaginal atrophy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    passive ankle dorsi flexion

    active ankle plantar flexion with arm up

    horizontal standing position

    Arm Description

    doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle)

    doing strengthening exercises of PFM in standing position with active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position

    doing strengthening exercises of PFM in standing position with horizontal standing position

    Outcomes

    Primary Outcome Measures

    pelvic floor muscles force

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2012
    Last Updated
    April 24, 2012
    Sponsor
    Mashhad University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01585090
    Brief Title
    Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mashhad University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial in different studies. The aim of this study is to assess the effect of ankle positions on pelvic floor muscle force during PFM exercises. This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle)(n=20), active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by using a pamphlet and face to face education. They were followed up every two week by telephone call and were asked to refer to women's clinic after 4 & 8 weeks. Pelvic floor muscles strength was assessed with brink score before and after intervention. Data analyzed by using analytic-descriptive statistics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Floor Muscle Syndrome
    Keywords
    Ankle positions, pelvic floor muscles strength, relaxation of pelvic floor muscles syndrome, doing strengthening exercises of pelvic floor muscles

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    passive ankle dorsi flexion
    Arm Type
    Experimental
    Arm Description
    doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle)
    Arm Title
    active ankle plantar flexion with arm up
    Arm Type
    Experimental
    Arm Description
    doing strengthening exercises of PFM in standing position with active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position
    Arm Title
    horizontal standing position
    Arm Type
    No Intervention
    Arm Description
    doing strengthening exercises of PFM in standing position with horizontal standing position
    Intervention Type
    Other
    Intervention Name(s)
    doing strengthening exercises of pelvic floor muscles
    Primary Outcome Measure Information:
    Title
    pelvic floor muscles force

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    55 Years
    Eligibility Criteria
    Inclusion Criteria: age 25-55 bma 20-30 women with relaxation of pelvic floor muscles syndrome in ph.ex and inspection Exclusion Criteria: severe deformity in knee joint and ankle regular exercise or yoga severe or moderate vaginal atrophy

    12. IPD Sharing Statement

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