The Spatiotemporal Gait Parameters in LDH Patient

NCT04409548 | Completed

• 1 other identifier: Bahçeşehir University
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Disc Herniation; Pain

Keywords

Pain; Gait analysis; Lumbar Disc Herniation; Spatiotemporal gait parameters; Gait asymmetry

Outcome Measures

Primary Outcomes (10)

• 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.

• 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

• 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

• Cadence (step/min)

  Cadence is the number of steps per minute.

  Changes from the cadence at 2 weeks

• Velocity (cm/s)

  Velocity is the distance covered in a given period.

  Changes from the velocity at 2 weeks

• 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

• 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

• 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

• 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

• 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).

Study Arms (3)

Lumbar Disc Hernaition Group

ACTIVE COMPARATOR

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.

Other: All of the spatial and Temporal Gait parameters

Healthy Control Group

ACTIVE COMPARATOR

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.

Other: All of the spatial and Temporal Gait parameters

Preoperative and Postoperative Group

ACTIVE COMPARATOR

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.

Other: All of the spatial and Temporal Gait parameters

Interventions

All of the spatial and Temporal Gait parameters OTHER

Healthy Control Group; Lumbar Disc Hernaition Group; Preoperative and Postoperative Group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead
• Bahçeşehir University: collaborator

Related Publications (2)

• 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.

  PMID: 25921552 BACKGROUND

• 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.

  PMID: 29709554 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• TUGBA KURU COLAK, Assoc. Prof.

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 1, 2020
• Study Start: May 1, 2016
• Primary Completion: December 29, 2017
• Study Completion: December 30, 2017
• Last Updated: September 27, 2022

Record last verified: 2020-05