The Spatiotemporal Gait Parameters in LDH Patient

NCT ID: NCT04409548

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-12-30

Brief Summary

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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

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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.

Conditions

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Lumbar Disc Herniation Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumbar Disc Hernaition Group

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.

Group Type ACTIVE_COMPARATOR

All of the spatial and Temporal Gait parameters

Intervention Type OTHER

Healthy Control Group

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.

Group Type ACTIVE_COMPARATOR

All of the spatial and Temporal Gait parameters

Intervention Type OTHER

Preoperative and Postoperative Group

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.

Group Type ACTIVE_COMPARATOR

All of the spatial and Temporal Gait parameters

Intervention Type OTHER

Interventions

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All of the spatial and Temporal Gait parameters

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TUGBA KURU COLAK, Assoc. Prof.

Role: STUDY_DIRECTOR

Marmara University

References

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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). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.

Reference Type BACKGROUND
PMID: 25921552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29709554 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/25921552

Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.

https://www.ncbi.nlm.nih.gov/pubmed/?term=Decompression+surgery+improves+gait+quality+in+patients+with+symptomatic+lumbar+spinal+stenosis.

Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.

Other Identifiers

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Bahçeşehir University

Identifier Type: -

Identifier Source: org_study_id

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