NCT Number: NCT04409548
The Spatiotemporal Gait Parameters in LDH Patient
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.
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Conditions
Age range
25 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Visual Analog Scale (VAS)
Time frame: The pain intensity of the patients was recorded immediately before performing the analysis.
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.
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Step length (cm)
Time frame: Changes from the step length at 2 weeks
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.
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Gait cycle length (cm)
Time frame: Changes from the gait cycle length at 2 weeks
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.
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Cadence (step/min)
Time frame: Changes from the cadence at 2 weeks
Cadence is the number of steps per minute.
-
Velocity (cm/s)
Time frame: Changes from the velocity at 2 weeks
Velocity is the distance covered in a given period.
-
Gait cycle duration (seconds)
Time frame: Changes from the gait cycle duration at 2 weeks
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.
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Step duration (seconds)
Time frame: Changes from the step duration at 2 weeks
Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.
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Double stance duration (seconds)
Time frame: Changes from the double stance duration at 2 weeks
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)
Time frame: Changes from the swing duration at 2 weeks
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
Time frame: Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).
Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.
Sponsors and collaborators
Lead sponsor
Marmara University
Other
Collaborators
- Bahçeşehir University
Registry information
Official study title
Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 1, 2020
- Registry last updated
- Sep 27, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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