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The Spatiotemporal Gait Parameters in LDH Patient

Primary Purpose

Lumbar Disc Herniation, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
All of the spatial and Temporal Gait parameters
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Pain, Gait analysis, Lumbar Disc Herniation, Spatiotemporal gait parameters, Gait asymmetry

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals who were diagnosed with LDH by a specialist;
  • Patients had a medical history and proven by MRI with more or less evidence of degenerative lumbar disc;
  • Aged between 25-80 years old;
  • Pain symptom on the lumbal area or lower extremity.

Exclusion Criteria:

  • Patients who have previously received surgery or physical therapy treatment;
  • Having congenital deformity in the spine or lower extremity;
  • History of spinal surgery or other diseases affecting gait;
  • Pregnancy;
  • Situations that may cause gait balance problems;
  • Using assistive gait appliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Lumbar Disc Hernaition Group

    Healthy Control Group

    Preoperative and Postoperative Group

    Arm Description

    The number of participants in this group is anticipated to be 153. The pain intensity of the patients was recorded by a Visual Analog Scale (VAS) immediately before performing the analysis. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.

    The number of participants in this group is anticipated to be 54. The participants were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.

    The number of participants in this group is anticipated to be 59. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day, before and 15 days after surgery.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (VAS)
    Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side. The patient was asked to mark the line point that represented his or her current pain.
    Step length (cm)
    Step length is the distance between the heel contact point of one foot and that of the other foot. The step length (cm) was recorded separately for both extremities.
    Gait cycle length (cm)
    Gait cycle length is the distance between successive foot contacts of the same limbs. The gait cycle length (cm) was recorded separately for both extremities.
    Cadence (step/min)
    Cadence is the number of steps per minute.
    Velocity (cm/s)
    Velocity is the distance covered in a given period.
    Gait cycle duration (seconds)
    Gait cycle duration is the time between successive foot contacts of the same limbs. The gait cycle duration (seconds) was recorded separately for both extremities.
    Step duration (seconds)
    Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.
    Double stance duration (seconds)
    Double stance duration is the time over which the body is supported by both legs. The double stance duration (seconds) was recorded separately for both extremities.
    Swing duration (seconds)
    Swing duration is the time taken for the leg to swing through while the body is in single support on the other leg. The swing duration (seconds) was recorded separately for both extremities.
    Gait symmetry
    Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2020
    Last Updated
    September 23, 2022
    Sponsor
    Marmara University
    Collaborators
    Bahçeşehir University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04409548
    Brief Title
    The Spatiotemporal Gait Parameters in LDH Patient
    Official Title
    Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    December 29, 2017 (Actual)
    Study Completion Date
    December 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University
    Collaborators
    Bahçeşehir University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study was to assessment on the interaction of spatial and temporal gait parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15 days after surgery.
    Detailed Description
    The participants were divided into LDH and healthy control groups. The analysis of the spatiotemporal gait parameters was performed using the "Win-Track" gait analysis platform system for two groups. In addition, the analysis of spatiotemporal gait parameters of 60 participants who had the planned lumbar discectomy surgery, was tested before and 15 days after surgery. The pain intensity of the patients was recorded by the Visual Analog Scale (VAS) immediately before performing the analysis. After then participants completed ten passes on the "Win-Track" Gait Analysis Platform at their self-selected walking speed. The arithmetic mean of the three flawless walking data was used for analysis. The gait symmetry index was used to calculate the walking asymmetry.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation, Pain
    Keywords
    Pain, Gait analysis, Lumbar Disc Herniation, Spatiotemporal gait parameters, Gait asymmetry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    208 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lumbar Disc Hernaition Group
    Arm Type
    Active Comparator
    Arm Description
    The number of participants in this group is anticipated to be 153. The pain intensity of the patients was recorded by a Visual Analog Scale (VAS) immediately before performing the analysis. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.
    Arm Title
    Healthy Control Group
    Arm Type
    Active Comparator
    Arm Description
    The number of participants in this group is anticipated to be 54. The participants were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.
    Arm Title
    Preoperative and Postoperative Group
    Arm Type
    Active Comparator
    Arm Description
    The number of participants in this group is anticipated to be 59. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day, before and 15 days after surgery.
    Intervention Type
    Other
    Intervention Name(s)
    All of the spatial and Temporal Gait parameters
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS)
    Description
    Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side. The patient was asked to mark the line point that represented his or her current pain.
    Time Frame
    The pain intensity of the patients was recorded immediately before performing the analysis.
    Title
    Step length (cm)
    Description
    Step length is the distance between the heel contact point of one foot and that of the other foot. The step length (cm) was recorded separately for both extremities.
    Time Frame
    Changes from the step length at 2 weeks
    Title
    Gait cycle length (cm)
    Description
    Gait cycle length is the distance between successive foot contacts of the same limbs. The gait cycle length (cm) was recorded separately for both extremities.
    Time Frame
    Changes from the gait cycle length at 2 weeks
    Title
    Cadence (step/min)
    Description
    Cadence is the number of steps per minute.
    Time Frame
    Changes from the cadence at 2 weeks
    Title
    Velocity (cm/s)
    Description
    Velocity is the distance covered in a given period.
    Time Frame
    Changes from the velocity at 2 weeks
    Title
    Gait cycle duration (seconds)
    Description
    Gait cycle duration is the time between successive foot contacts of the same limbs. The gait cycle duration (seconds) was recorded separately for both extremities.
    Time Frame
    Changes from the gait cycle duration at 2 weeks
    Title
    Step duration (seconds)
    Description
    Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.
    Time Frame
    Changes from the step duration at 2 weeks
    Title
    Double stance duration (seconds)
    Description
    Double stance duration is the time over which the body is supported by both legs. The double stance duration (seconds) was recorded separately for both extremities.
    Time Frame
    Changes from the double stance duration at 2 weeks
    Title
    Swing duration (seconds)
    Description
    Swing duration is the time taken for the leg to swing through while the body is in single support on the other leg. The swing duration (seconds) was recorded separately for both extremities.
    Time Frame
    Changes from the swing duration at 2 weeks
    Title
    Gait symmetry
    Description
    Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.
    Time Frame
    Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals who were diagnosed with LDH by a specialist; Patients had a medical history and proven by MRI with more or less evidence of degenerative lumbar disc; Aged between 25-80 years old; Pain symptom on the lumbal area or lower extremity. Exclusion Criteria: Patients who have previously received surgery or physical therapy treatment; Having congenital deformity in the spine or lower extremity; History of spinal surgery or other diseases affecting gait; Pregnancy; Situations that may cause gait balance problems; Using assistive gait appliance.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    TUGBA KURU COLAK, Assoc. Prof.
    Organizational Affiliation
    Marmara University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25921552
    Citation
    Toosizadeh N, Yen TC, Howe C, Dohm M, Mohler J, Najafi B. Gait behaviors as an objective surgical outcome in low back disorders: A systematic review. Clin Biomech (Bristol, Avon). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.
    Results Reference
    background
    PubMed Identifier
    29709554
    Citation
    Loske S, Nuesch C, Byrnes KS, Fiebig O, Scharen S, Mundermann A, Netzer C. Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis. Spine J. 2018 Dec;18(12):2195-2204. doi: 10.1016/j.spinee.2018.04.016. Epub 2018 Apr 27.
    Results Reference
    background
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/25921552
    Description
    Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/?term=Decompression+surgery+improves+gait+quality+in+patients+with+symptomatic+lumbar+spinal+stenosis.
    Description
    Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.

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    The Spatiotemporal Gait Parameters in LDH Patient

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