- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03426852
INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT IN INDIVIDUALS WITH BACK PAIN
February 7, 2018 updated by: hhotaman, Hacettepe University
INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT VARIABILITY IN INDIVIDUALS WİTH LUMBAR HERNIATION NUCLEUS PULPOSUS
Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain.
It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study.
Gait characteristics of participants will be evaluate with treadmill.
Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses.
Gait speed, cadance, step lengths, time on each foot and step length variabilities will be recorded.
Study Overview
Detailed Description
Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain.
It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study.
Gait characteristics of participants will be evaluate with treadmill.
Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses.
Gait speed, cadance, step lengths, time on each foot and step length variabilities will be record
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Individuals with lumbar disc herniation with or without sacroiliac dysfunction, age between 18-50 years.
Description
Inclusion Criteria:
Have current back pain Have Lumbar Disc Herniation diagnosis Have sacroiliac dysfunction
Exclusion Criteria:
Do not want to participate Have another systemic, neurologic or orthopedic problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Individuals with lumbar back pain plus sacroiliac disc herniation
|
No intervention
|
|
Control Group
Individuals with lumbar back pain
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step Length Variability
Time Frame: First minute
|
Covariance of variability for right and left step lenghts.
|
First minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2018
Primary Completion (Anticipated)
March 30, 2018
Study Completion (Anticipated)
April 30, 2018
Study Registration Dates
First Submitted
February 2, 2018
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 8, 2018
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
February 7, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G0-17601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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