Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2016-05-01
2017-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lumbar Disc Hernaition Group
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.
All of the spatial and Temporal Gait parameters
Healthy Control Group
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.
All of the spatial and Temporal Gait parameters
Preoperative and Postoperative Group
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.
All of the spatial and Temporal Gait parameters
Interventions
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All of the spatial and Temporal Gait parameters
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
80 Years
ALL
Yes
Sponsors
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Bahçeşehir University
OTHER
Marmara University
OTHER
Responsible Party
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Principal Investigators
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TUGBA KURU COLAK, Assoc. Prof.
Role: STUDY_DIRECTOR
Marmara University
References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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.
Other Identifiers
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Bahçeşehir University
Identifier Type: -
Identifier Source: org_study_id
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