Clinical trial NCT04409548: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Pain
Keywords: Pain
Gait analysis
Lumbar Disc Herniation
Spatiotemporal gait parameters
Gait asymmetry
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
First posted: 2020-06-01
Enrollment: 208
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: The pain intensity of the patients was recorded immediately before performing the analysis.
measure: Step length (cm)
timeFrame: Changes from the step length at 2 weeks
measure: Gait cycle length (cm)
timeFrame: Changes from the gait cycle length at 2 weeks
measure: Cadence (step/min)
timeFrame: Changes from the cadence at 2 weeks
measure: Velocity (cm/s)
timeFrame: Changes from the velocity at 2 weeks
measure: Gait cycle duration (seconds)
timeFrame: Changes from the gait cycle duration at 2 weeks
measure: Step duration (seconds)
timeFrame: Changes from the step duration at 2 weeks
measure: Double stance duration (seconds)
timeFrame: Changes from the double stance duration at 2 weeks
measure: Swing duration (seconds)
timeFrame: Changes from the swing duration at 2 weeks
measure: Gait symmetry
timeFrame: Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University
name: TUGBA KURU COLAK, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.
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.