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Biomechanical Effects of Wearing a Sacroiliac Belt in Women

Primary Purpose

Pelvic Girdle Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sacroiliac belt
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pelvic Girdle Pain focused on measuring sacroiliac belt, kinematics, stability, pelvic girdle pain, sacroiliac instability

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females
  • Individuals with isolated SI joint dysfunction
  • Individuals with shoe size 6, 7, 8 or 9 US

and matched controls by age (within 5 years), BMI (within one point) and parity

Exclusion Criteria:

  • Pregnancy in the last year or presently pregnant
  • Significant lumbar dysfunction
  • Significant hip dysfunction
  • Leg length discrepancy of 1 cm or more
  • Women who have previously undergone prolotherapy or SI joint injections
  • Women with previous lower back, hip, knee or ankle surgery
  • Inability to stand for 60 sec unaided or to walk unaided.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Sacroiliac belt on and off

    Arm Description

    Belt on and belt off

    Outcomes

    Primary Outcome Measures

    Explore if 95% confidence ellipse area of the center of pressure or kinematic measures can distinguish women with PGP from women without PGP when a SI belt is applied
    Pressure insoles will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used. Kinematic data will be collected using eight high speed video cameras at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side. Walking speed will be monitored using photo electronic cells. Identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA).

    Secondary Outcome Measures

    95% confidence ellipse area of the center of pressure
    Pressure insoles (Pedar, novel GmbH, Germany) will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. Prior to testing, the insoles will be calibrated as per the manufacture's protocol. All data will be analyzed using custom Matlab scripts. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used.Gait variability will be assessed by calculating the average position of the CoP in the medial-lateral direction during walking using pedar pressure insoles. The mean and standard deviation of the average CoP position will be defined as gait variability in medial-lateral direction calculated for each subject, foot, and condition.
    kinematic changes of lower extremity
    A force plate (Kistler Instrumente AG, Switzerland) recording at 2400 Hz will be positioned in the middle of a 15 meter walkway to measure ground reaction forces (GRF) during standing and walking. The threshold for determining heel strike wil be 20 N. Walking speed will be monitored using photo electronic cells (model TC Timing System; Brower Timing Systems, Draper, UT). Discrete kinematic and kinetic variables will be identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA). Kinematic data will be collected using eight high speed video cameras (Motion Analysis Corporation, Santa Rosa, USA) Version 3.6.1.1315 at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side.

    Full Information

    First Posted
    October 24, 2017
    Last Updated
    November 6, 2017
    Sponsor
    University of Calgary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03334799
    Brief Title
    Biomechanical Effects of Wearing a Sacroiliac Belt in Women
    Official Title
    A Case-Control Pilot Study on the Biomechanical Effects of Wearing a Sacroiliac Belt in Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 25, 2015 (Actual)
    Primary Completion Date
    May 29, 2015 (Actual)
    Study Completion Date
    September 9, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Calgary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Women with pelvic girdle pain PGP) often get relief from using a sacroiliac belt. The study will explore if there are differences and in the changes of lower body movement in stability with the belt on and with the belt off. Women with PGP will be matched with women without to explore if there is a difference between these two groups. This will be looked at in standing and in walking.
    Detailed Description
    SacroIliac (SI) joint dysfunction (also called pelvic girdle pain) has been associated with impaired load transfer across the lumbopelvic region. This can result in lower back pain as well as poor biomechanical adaptation during walking. Sacroiliac (SI) belts have typically been prescribed in order to mitigate pain and improve load transfer in individuals with SI joint dysfunction. It has been speculated that SI belts have the ability to instantaneously increase joint stability, and as a result improve load transfer and muscle activation and recruitment. However, this speculation is primarily based on anecdotal evidence; there is little biomechanical research supporting the effects of wearing an SI belt. In order to gain an improved understanding of the biomechanical effects of wearing an SI belt, the investigators propose to conduct a study with the following key objectives: Determine if there are differences with respect to neuromuscular, kinematic, or pressure patterns during walking and/or standing between healthy stable individuals and individuals with SI joint dysfunction Determine if wearing an SI belt affects neuromuscular, kinematic, or pressure patterns during walking and/or standing in women with sacroiliac instability Variables measured will include: Kinematics will be collected to quantify posture and joint angles Kinetics will be collected to quantify ground reaction forces Plantar pressure will be collected to quantify force distribution and center or pressure Joint moments (Lumbar-pelvic and Hip) will be added as variables. The investigators will use inverse dynamics to calculate various joint moments during walking.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Girdle Pain
    Keywords
    sacroiliac belt, kinematics, stability, pelvic girdle pain, sacroiliac instability

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    case control
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sacroiliac belt on and off
    Arm Type
    Other
    Arm Description
    Belt on and belt off
    Intervention Type
    Device
    Intervention Name(s)
    sacroiliac belt
    Other Intervention Name(s)
    pelvic belt
    Intervention Description
    standing and walking with the belt on and with the belt off
    Primary Outcome Measure Information:
    Title
    Explore if 95% confidence ellipse area of the center of pressure or kinematic measures can distinguish women with PGP from women without PGP when a SI belt is applied
    Description
    Pressure insoles will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used. Kinematic data will be collected using eight high speed video cameras at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side. Walking speed will be monitored using photo electronic cells. Identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA).
    Time Frame
    within 2 months of enrollment, measured at one point in time
    Secondary Outcome Measure Information:
    Title
    95% confidence ellipse area of the center of pressure
    Description
    Pressure insoles (Pedar, novel GmbH, Germany) will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. Prior to testing, the insoles will be calibrated as per the manufacture's protocol. All data will be analyzed using custom Matlab scripts. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used.Gait variability will be assessed by calculating the average position of the CoP in the medial-lateral direction during walking using pedar pressure insoles. The mean and standard deviation of the average CoP position will be defined as gait variability in medial-lateral direction calculated for each subject, foot, and condition.
    Time Frame
    within 2 months of enrollment, measured at one point in time
    Title
    kinematic changes of lower extremity
    Description
    A force plate (Kistler Instrumente AG, Switzerland) recording at 2400 Hz will be positioned in the middle of a 15 meter walkway to measure ground reaction forces (GRF) during standing and walking. The threshold for determining heel strike wil be 20 N. Walking speed will be monitored using photo electronic cells (model TC Timing System; Brower Timing Systems, Draper, UT). Discrete kinematic and kinetic variables will be identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA). Kinematic data will be collected using eight high speed video cameras (Motion Analysis Corporation, Santa Rosa, USA) Version 3.6.1.1315 at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side.
    Time Frame
    within 2 months of enrollment, measured at one point in time

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    women
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Females Individuals with isolated SI joint dysfunction Individuals with shoe size 6, 7, 8 or 9 US and matched controls by age (within 5 years), BMI (within one point) and parity Exclusion Criteria: Pregnancy in the last year or presently pregnant Significant lumbar dysfunction Significant hip dysfunction Leg length discrepancy of 1 cm or more Women who have previously undergone prolotherapy or SI joint injections Women with previous lower back, hip, knee or ankle surgery Inability to stand for 60 sec unaided or to walk unaided.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Magali Robert
    Organizational Affiliation
    Foothils Hospital Cumming School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data will be stored in repository for access by request

    Learn more about this trial

    Biomechanical Effects of Wearing a Sacroiliac Belt in Women

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