Lumbar Disc HerniationNCT04230733
Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation
An observational study of Lumbar Disc Herniation and Gait Analysis, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Gait Analysis, Pelvis Abnormal
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Aug 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted to Jaseng Hospital of Korean Medicine and got gait analysis
Who may be able to join
- Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
- Patient who got gait analysis
Who cannot join
- Patients without MRI and X-ray
- Patient diagnosed with ankle disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Correlation Analysis of Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation : Retrospective Study Using Electronic Medical Record Data
The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.
Read the detailed description
Walking is a repetitive movement that moves your body while keeping your posture stable. The pelvis is located between the hip and lumbar region, where many muscles are attached to regulate the movement of the hip and lumbar spine. Asymmetrical pelvic alignment affects stability of the lower extremities and trunk, making normal walking difficult. The purpose of this study is to investigate the pattern of gait according to pelvic displacement in patients with lumbar disc herniation.
- Conditions
- Lumbar Disc Herniation, Gait Analysis, Pelvis Abnormal
- Keywords
- Gait, Pelvic height, Leg Length Discrepancy, Sacral angle
- Medical subject headings
- Intervertebral Disc Displacement, Leg Length Inequality
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between pelvic displacement and gait parameters
<Pelvic displacement>
- Sacral angle : The angle between the parallel line drawn on the first vertebral body(Sacrum) and the horizontal line
- Leg Length Discrepancy : Difference between the values of both sides by measuring the height of the upper edge of both femoral heads
- Pelvic height : Difference between the left and right peaks of both iliac crests
- Gravity line : Line passing through the gravity point(L3) of the human body
<Gait parameters>
Step, Stance phase, Swing phase, Single support, Double support, Step time, Stride, Cadence, Load response, Pre swing, Gait cycle, Speed, Acceleration, contact phase, foot flat, propulsive, PCI
Measured: A week after data collected
Secondary outcomes (1)
Numeric Rating Scale
Using NRS-11(0 to 10) which is measured at first visit
Measured: A week after data collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Aug 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, KMD, Ph.D, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230733
- Sponsor's protocol ID
- JS-CT-2018-08
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation : Retrospective Study Using Electronic Medical Record Data
- ClinicalTrials.gov ID
- NCT04230733
- Acronym / sponsor ID
- JS-CT-2018-08
- Conditions
- Lumbar Disc Herniation, Gait Analysis, Pelvis Abnormal
- Keywords
- Gait, Pelvic height, Leg Length Discrepancy, Sacral angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.
Detailed description
Walking is a repetitive movement that moves your body while keeping your posture stable. The pelvis is located between the hip and lumbar region, where many muscles are attached to regulate the movement of the hip and lumbar spine. Asymmetrical pelvic alignment affects stability of the lower extremities and trunk, making normal walking difficult. The purpose of this study is to investigate the pattern of gait according to pelvic displacement in patients with lumbar disc herniation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to Jaseng Hospital of Korean Medicine and got gait analysis
Key inclusion criteria (2 listed)
- Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
- Patient who got gait analysis
Key exclusion criteria (2 listed)
- Patients without MRI and X-ray
- Patient diagnosed with ankle disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between pelvic displacement and gait parameters
Time frame: A week after data collected
<Pelvic displacement> * Sacral angle : The angle between the parallel line drawn on the first vertebral body(Sacrum) and the horizontal line * Leg Length Discrepancy : Difference between the values of both sides by measuring the height of the upper edge of both femoral heads * Pelvic height : Difference between the left and right peaks of both iliac crests * Gravity line : Line passing through the gravity point(L3) of the human body <Gait parameters> Step, Stance phase, Swing phase, Single support, Double support, Step time, Stride, Cadence, Load response, Pre swing, Gait cycle, Speed, Acceleration, contact phase, foot flat, propulsive, PCI
1 secondary outcome
Numeric Rating Scale
Time frame: A week after data collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, KMD, Ph.D study director
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Gait Analysis, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between pelvic displacement and gait parameters (time frame: A week after data collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.