Biomechanical Effects of Wearing a Sacroiliac Belt in Women

NCT03334799 | Completed

• 1 other identifier: 14-2323
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Girdle Pain

Keywords

sacroiliac belt; kinematics; stability; pelvic girdle pain; sacroiliac instability

Outcome Measures

Primary Outcomes (1)

• 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).

  within 2 months of enrollment, measured at one point in time

Secondary Outcomes (2)

• 95% confidence ellipse area of the center of pressure

  within 2 months of enrollment, measured at one point in time

• kinematic changes of lower extremity

  within 2 months of enrollment, measured at one point in time

Study Arms (1)

Sacroiliac belt on and off

OTHER

Belt on and belt off

Device: sacroiliac belt

Interventions

sacroiliac belt DEVICE

standing and walking with the belt on and with the belt off

Also known as: pelvic belt

Sacroiliac belt on and off

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Magali Robert

  Foothils Hospital Cumming School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case control

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 7, 2017
• Study Start: February 25, 2015
• Primary Completion: May 29, 2015
• Study Completion: September 9, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-10