- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585090
Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: passive ankle dorsi flexion
doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle)
|
|
|
EXPERIMENTAL: active ankle plantar flexion with arm up
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
|
|
|
NO_INTERVENTION: horizontal standing position
doing strengthening exercises of PFM in standing position with horizontal standing position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
pelvic floor muscles force
|
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 89094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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