The Spatiotemporal Gait Parameters in LDH Patient

Pain Clinical Trial

Official title:

Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409548
• Other study ID #: Bahçesehir University
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: May 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 30, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Pain

Intervention

Other:
• All of the spatial and Temporal Gait parameters

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Marmara University	Bahçesehir University

References & Publications (2)

Loske S, Nüesch C, Byrnes KS, Fiebig O, Schären S, Mündermann 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The pain intensity of the patients was recorded immediately before performing the analysis.
Primary	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.	Changes from the step length at 2 weeks
Primary	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.	Changes from the gait cycle length at 2 weeks
Primary	Cadence (step/min)	Cadence is the number of steps per minute.	Changes from the cadence at 2 weeks
Primary	Velocity (cm/s)	Velocity is the distance covered in a given period.	Changes from the velocity at 2 weeks
Primary	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.	Changes from the gait cycle duration at 2 weeks
Primary	Step duration (seconds)	Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.	Changes from the step duration at 2 weeks
Primary	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.	Changes from the double stance duration at 2 weeks
Primary	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.	Changes from the swing duration at 2 weeks
Primary	Gait symmetry	Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.	Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).

External Links

•   Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.
•   Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.