NCT04230733

Brief Summary

The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 13, 2019

Last Update Submit

January 13, 2020

Conditions

Lumbar Disc HerniationGait AnalysisPelvis Abnormal

Keywords

GaitPelvic heightLeg Length DiscrepancySacral angle

Outcome Measures

Primary Outcomes (1)

  • 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

    A week after data collected

Secondary Outcomes (1)

  • Numeric Rating Scale

    A week after data collected

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are admitted to Jaseng Hospital of Korean Medicine and got gait analysis

You may qualify if:

  • 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

You may not qualify if:

  • Patients without MRI and X-ray
  • Patient diagnosed with ankle disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementLeg Length Inequality

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBone Diseases, Developmental

Study Officials

  • In-Hyuk Ha, KMD, Ph.D

    Jaseng Medical Foundation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 13, 2019

First Posted

January 18, 2020

Study Start

August 20, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

January 18, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)