An interventional study of sacroiliac belt in Pelvic Girdle Pain, sponsored by University of Calgary. Completed. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by University of Calgary · Not applicable, Interventional, and Screening
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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.
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:
Variables measured will include:
63 studies on the registry are indexed under Pelvic Girdle Pain; 14 are open to participants now.
This study's enrollment of 10 is below the median of 53 across 45 interventional studies indexed under Pelvic Girdle Pain.
Browse Pelvic Girdle Pain studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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and matched controls by age (within 5 years), (within one point) and parity
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Belt on and belt off
Device: sacroiliac belt
standing and walking with the belt on and with the belt off
Also known as: pelvic belt
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).
Time frame: within 2 months of enrollment, measured at one point in time
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.
Time frame: within 2 months of enrollment, measured at one point in time
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.
Time frame: within 2 months of enrollment, measured at one point in time
No study locations are listed for this record.
Plan to share: Undecided — Data will be stored in repository for access by request
No publications or documents are linked to this record.
Ran from Feb 2015 to primary completion in May 2015, 3 months.
Of 32 interventional studies with no phase under Pelvic Girdle Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 59. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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