Lumbar Disc HerniationNCT04409548
The Spatiotemporal Gait Parameters in LDH Patient
A study testing All of the spatial and Temporal Gait parameters in people with Lumbar Disc Herniation and Pain, run by Marmara University.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Pain
- What is being tested?
- All of the spatial and Temporal Gait parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study
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.
Read the 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.
- Conditions
- Lumbar Disc Herniation, Pain
- Being tested
- All of the spatial and Temporal Gait parameters
- Keywords
- Pain, Gait analysis, Lumbar Disc Herniation, Spatiotemporal gait parameters, Gait asymmetry
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All of the spatial and Temporal Gait parametersOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: All of the spatial and Temporal Gait parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Changes from the gait cycle length at 2 weeks
Cadence (step/min)
Cadence is the number of steps per minute.
Measured: Changes from the cadence at 2 weeks
Velocity (cm/s)
Velocity is the distance covered in a given period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 May 2016
- Primary completion29 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Sponsor
- Investigators
- TUGBA KURU COLAK, Assoc. Prof., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409548
- Sponsor's protocol ID
- Bahçeşehir University
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25921552Loske 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.
PubMed 29709554
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04409548
- Acronym / sponsor ID
- Bahçeşehir University
- Conditions
- Lumbar Disc Herniation, Pain
- Keywords
- Pain, Gait analysis, Lumbar Disc Herniation, Spatiotemporal gait parameters, Gait asymmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 1 May 2016 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar Disc Hernaition Group | Active comparator | Other: All of the spatial and Temporal Gait parametersThe 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. |
| Healthy Control Group | Active comparator | Other: All of the spatial and Temporal Gait parametersThe 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. |
| Preoperative and Postoperative Group | Active comparator | Other: All of the spatial and Temporal Gait parametersThe 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. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All of the spatial and Temporal Gait parameters | Other | Healthy Control Group, Lumbar Disc Hernaition Group, Preoperative and Postoperative Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 25921552Toosizadeh 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.
- Background: PubMed 29709554Loske 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.
- Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.Link provided by the sponsor.
- Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.Link provided by the sponsor.
Related trials for Lumbar Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA KURU COLAK, Assoc. Prof. study director
Marmara University
Questions about this trial
What is this clinical trial studying?
A study testing All of the spatial and Temporal Gait parameters in people with Lumbar Disc Herniation and Pain, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: The pain intensity of the patients was recorded immediately before performing the analysis.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.