Trial document




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  DRKS00008030

Trial Description

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Title

Feasibility study for the development of a sensorimotor insole for postnatal activation of the pelvic floor

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The pelvic floor is often weakened after childbirth and many women experience urine leakage. This loss of urine, which can range from a few drops at a cough or sneeze to quite large amounts, may be associated with lifting, carrying or a long walk.
The aim of this study is to investigate if there are gait variables that can be measured in a movement laboratory and that are related to the activity of the pelvic floor. Also, we want to examine if wearing the shoe “kyBoot” (by the company kybun) increases the activity of the pelvic floor during standing and walking. Additionally, we will measure if a surface that stimulates the sole of the foot causes a change in the activity of the pelvic floor.
During the study, different conditions will be tested. First, experiments are carried out with shoes, with subjects standing or walking at a self-selected speed. Then, experiments with bare feet will be carried out.

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Brief Summary in Scientific Language

Introduction: During pregnancy and birth, women are at a significantly higher risk of developing a urinary incontinence, defined as any involuntary loss of urine. Longitudinal studies have shown that with no treatment the urinary incontinence will persist after one year after birth. Training of the pelvic floor musculature has shown improvements of the symptoms of incontinence. While most women are aware of the benefits of pelvic floor training, such trainings are rarely implemented in everyday life. This is mainly due to limited time besides taking care of a newborn. Therefore, training of the pelvic floor should be easily feasible for new mothers, such as wearing a shoe. However, there is only very limited literature about the effect of surface or footwear on the activation of the pelvic floor muscles.
Goal: The primary goal of this study is to show the activity of the pelvic floor musculature during stance and gait in different conditions (soft shoe, with and without proprioceptive insole). The secondary goal is to show possible correlations between pelvic floor activity and kinematic gait parameters or activity of skeletal muscles that can be measured using skin surface EMG.
Design: The study is a cross-sectional study with different conditions (including control condition) that will be measured in one session. The conditions are barefoot, shod, shod with proprioceptive insole. 20 healthy subjects or with a urinary incontinence after birth will be recruited.
Results: Kinematics will be measured using a Vicon Motion System, surface EMG will be measured with a myon system and pelvic floor activity with the Nexus-10 system. The activity of the pelvic floor will be measured in different conditions and compared between conditions as well as correlated with kinematics and surface EMG. An ANOVA and Pearson’s correlation will be calculated for statistical analysis.

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Organizational Data

  •   DRKS00008030
  •   2015/04/24
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  •   yes
  •   Approved
  •   2015-0126, Kantonale Ethikkommission Zürich
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Secondary IDs

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Health Condition or Problem studied

  •   N39.3 -  Stress incontinence
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Interventions/Observational Groups

  •   Kinematics, skeletal muscle activity and activity of pelvic floor muscles will be measured in healthy subjects or subjects with urinary incontinence after birth in one measurement session.
    Subjects will perform standing and walking (at self-selected speed) trials in following conditions: barefoot, in shoe with soft-elastic sole, and in shoe with soft-elastic sole and proprioceptive insole.
    Kinematics will be measured using skin-mounted markers that are recorded with infra-red cameras. Skeletal muscle activity (trunk and back) will be recorded with surface electrods. The activity of the pelvic floor muscles will be recorded with a vaginal sensor.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

activation of pelvic floor: root mean square of EMG signal and time point of activation of different conditions. Pelvic floor activity will be recorded with a vaginal sensor and the Nexus-10 device

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Secondary Outcome

correlation of pelvic floor activity with gait parameters: 3-dimensional joint/segment angles and time point of activity of skeletal muscle EMG

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/11/24
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

8 weeks to 6 months after birth
healthy or mild stress incontinence (self-reported)

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Exclusion Criteria

severe childbirth related injuries,
infection of urinary passage,
chronic respiratory diseases,
neurologic impariments,
diabetes mellitus,
kidney or intestinal diseases,
chronic back pain,
joint diseases,
musculoskeletal injuries (in last 6 months),
amputations,
experience with instable shoes

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zürcher Hochschule für Angewandte Wissenschaften
    • Ms.  Dr.  Eveline  Graf 
    • Technikumstrasse 71, Postfach
    • 8401  Winterthur
    • Switzerland
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    • Zürcher Hochschule für Angewandte Wissenschaften
    • Ms.  Dr.  Eveline  Graf 
    • Technikumstrasse 71, Postfach
    • 8401  Winterthur
    • Switzerland
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    • Zürcher Hochschule für Angewandte Wissenschaften
    • Ms.  Dr.  Eveline  Graf 
    • Technikumstrasse 71, Postfach
    • 8401  Winterthur
    • Switzerland
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Sources of Monetary or Material Support

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    • Kommission für Technologie und Innovation KTI
    • Einsteinstrasse 2
    • 3003  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2018/01/11
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.