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
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
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
NCT ID
NCT03334799
First Posted
October 24, 2017
Last Updated
November 6, 2017
Sponsor
University of Calgary
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
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Biomechanical Effects of Wearing a Sacroiliac Belt in Women
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