Lumbar Spinal StenosisNCT06750055
Gait Assessment in Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar spinal stenosis (LSS) is a clinical condition in which the structures within the canal are compressed as a result of the narrowing of the lumbar spinal canal and nerve root canals, which is often caused by bones and soft tissues, causing back pain and neurological deficits in the lower extremities. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with spinal stenosis who have undergone surgery
Who may be able to join
- Between the ages of 20-65 and discharged from hospital,
- At least 6 weeks and at most 3 months after surgery,
- No other orthopedic and neurological problems,
- Able to communicate,
- Individuals who agree to participate in the study will be included in the study.
Who cannot join
- Cognitive impairment,
- Other neurologic, psychiatric and/or orthopedic problems other than lumbar spinal stenosis,
- Medically unstable,
- Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
Fatma ÖZ, 5358510875, fatmaoz8499@gmail.com
About this study
Official title: Comparison of Walking With Wearable Gait Analysis System in Patients Undergoing Lumbar Spinal Stenosis Surgery
Lumbar spinal stenosis (LSS) is a clinical condition in which the structures within the canal are compressed as a result of the narrowing of the lumbar spinal canal and nerve root canals, which is often caused by bones and soft tissues, causing back pain and neurological deficits in the lower extremities. The incidence in the general population has been reported as 1.7-8%. It begins to be seen after the age of 50 and its incidence increases after the age of 65. According to studies, LSS has been detected in 5% of patients who apply to a general practitioner with persistent back pain. Although it can be congenital, most cases of lumbar spinal stenosis are caused by changes in the aging spine as a result of degenerative processes. Changes that can lead to lumbar spinal stenosis include facet joint hypertrophy, decreased intervertebral disc height, osteophyte formation and ligamentum flavum hypertrophy. Clinical findings of LSS include symptoms such as back pain, leg pain, paresthesia, weakness and neurogenic claudication. Patients with neurogenic claudication experience increased pain when walking and standing and decreased pain when bending forward. Patients with LSS often change their spinal posture to allow more lumbar flexion to minimize pain and symptoms while walking; this can lead to gait abnormalities.
Walking function is important for the maintenance of daily living activities. Gait disturbance is associated with poor health outcomes. In a gait cycle, the foot has two distinct phases: stance and swing. These gait phases can be analyzed as a proportion of the gait cycle and compared to normative values. Furthermore, with the use of more advanced systems and devices, it is also possible to assess asymmetries and gait variability in the pelvis and other structures during gait.
Read more
Technological advances have led to the emergence of reliable surface sensor technologies capable of gait analysis in the form of wearable accelerometers. These devices provide continuous and objective data streams, including parameters such as daily step count, step rate, and step length. Numerous studies have investigated walking function in LSS patients using various devices including motion capture systems, inertial sensors, accelerometers, wearable technologies, electromyography (EMG) and force platforms. In the study, walking impairment in LSS patients compared to healthy participants was a significant decrease in walking speed and step length, a slight decrease in cadence and a slight increase in step duration. As the double-step support and stance phase ratios increase, the swing phase ratio decreases. Walking asymmetry between the feet also increases in all phases including stance, swing and double-step support. In addition, LSS patients may exhibit gait variability with each step. The reasons for these changing gait patterns are thought to be radicular pain, muscle weakness, low walking tolerance and increased instability with lumbar spine posture in the lumbar extension position during walking.
Winter et al. evaluated the walking ability in daily life in patients with knee or hip osteoarthritis and lumbar spinal stenosis with the help of a wearable accelerometer device. As a result of the study, walking ability was found to be significantly lower in LSS individuals compared to healthy individuals.
Santos et al. examined the kinematic and spatiotemporal gait parameters in patients who underwent surgery with a diagnosis of disc herniation or lumbar stenosis before surgery and 1 and 6 months after surgery. As a result of the study, there was an increase in the pelvis, hip and knee range of motion (ROM) after surgery in the disc herniation group, while there was a decrease in the hip ROM values in the stenosis group. It was also observed that the pelvis and hip ROM of both groups remained smaller in the stance phase compared to the control group.
Papadakis et al. examined the changes in gait in patients with lumbar spinal stenosis with the help of an accelerometer before surgery and 6 and 12 months after surgery and showed that there was a significant decrease in the changes in gait in the postoperative period. It was observed that the improvement in the changes in gait was greater in the first month after surgery compared to the 6th and 12th months after surgery.
Purpose of the study:
The study was planned to compare the gait in healthy and patient groups in patients who underwent LSS surgery.
- Conditions
- Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lumbar spinal stenosis patient group | Assessment of Disability Status (Oswestry Disability Index) Pain Assessment (Visual Analog Scale-VAS) Quality of Life Assessment (SF-12) Evaluation of Gait Parameters: 10 Meter Walk Test-BTS G-Walk gait analysis system | |
| healthy control group | Quality of Life Assessment (SF-12) Evaluation of Gait Parameters: 10 Meter Walk Test-BTS G-Walk gait analysis system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Disability Status (Oswestry Disability Index)
It was developed to assess the degree of functional loss in low back pain. The Oswestry Disability Index (OSI), which was shown to be valid and reliable in Turkish in 2004, consists of 10 items. The items question the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleeping, the degree of change in pain, travel and social life. There are six statements under each item, which the patient marks as appropriate for his/her condition. The first statement is scored as "0", the sixth statement as "5". The score given by the participant to each question is added up. The total score received by the patient is divided by the maximum possible score of 50 points and multiplied by 100 to calculate the percentage. The maximum percentage is "100", the minimum percentage is "0". As the total percentage score increases, the level of disability also increases.
Measured: 10 minutes
Pain Assessment (Visual Analog Scale-VAS)
It is a scale consisting of a single 10 cm line and the pain intensity of patients is evaluated with this scale. Participants are asked to mark the pain intensity at rest and during activity with a pencil on two separate 10 cm lines. The starting point on the scale is expressed as: no pain at all, the last point; the most severe pain encountered in life. When calculating, the distance between the marked point and the starting point is measured in cm with meters. An increase in the score indicates an increase in the intensity of the pain.
Measured: 2 minutes
Quality of Life Assessment (SF-12)
It is a shortened and simplified form of the SF-36 Quality of Life Scale used to assess quality of life. Its Turkish validity and reliability were conducted by Soylu et al. in 2022. The results of the study show that the psychometric properties of the Turkish form of SF-12 are similar to the original version, and therefore it can be used in applications and research to be conducted in our country as an alternative to SF-36. It consists of a total of 12 questions. Each question has its own score. When calculating, 8 sub-items are calculated as percentages, including general health, physical function, physical role difficulty, emotional role difficulty, social function, pain, mental health and vitality. In percentage expressions ranging from 0 to 100, a high percentage indicates good health status.
Measured: 5 minutes
10 Meter Walk Test
It is a test used to evaluate walking. A 10-meter area is determined in advance by the evaluator who will perform the test. The participant is asked to walk at his normal speed along the 10-meter area. When the participant is at the starting line, the stopwatch is started with the start command and the time is stopped when he crosses the finish line. In order to minimize the margin of error, two measurements are taken and the best value is recorded in meters/second (m/s).
Measured: 5 minutes
BTS G-Walk gait analysis system
It is an analysis method that measures all important information such as spatio-temporal parameters of walking, general walking kinematics, spine kinematics and displays this in a computer environment. In the BTS G-Walk walking analysis system, the analysis port is attached to the patient's L5-S1 level and the results are transferred to the computer via the Bluetooth system. With this system; while comparing the walking analysis with normal values in the right and left extremities, it also allows the kinematic analysis of the pelvis to be performed in 3 planes. The resulting reports are created automatically and the system compares directly with the normal range results.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start13 Jun 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma OZ, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750055
- Sponsor's protocol ID
- FOZ
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Walking With Wearable Gait Analysis System in Patients Undergoing Lumbar Spinal Stenosis Surgery
- ClinicalTrials.gov ID
- NCT06750055
- Acronym / sponsor ID
- FOZ
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
Lumbar spinal stenosis (LSS) is a clinical condition in which the structures within the canal are compressed as a result of the narrowing of the lumbar spinal canal and nerve root canals, which is often caused by bones and soft tissues, causing back pain and neurological deficits in the lower extremities. The incidence in the general population has been reported as 1.7-8%. It begins to be seen after the age of 50 and its incidence increases after the age of 65. According to studies, LSS has been detected in 5% of patients who apply to a general practitioner with persistent back pain. Although it can be congenital, most cases of lumbar spinal stenosis are caused by changes in the aging spine as a result of degenerative processes. Changes that can lead to lumbar spinal stenosis include facet joint hypertrophy, decreased intervertebral disc height, osteophyte formation and ligamentum flavum hypertrophy. Clinical findings of LSS include symptoms such as back pain, leg pain, paresthesia, weakness and neurogenic claudication. Patients with neurogenic claudication experience increased pain when walking and standing and decreased pain when bending forward. Patients with LSS often change their spinal posture to allow more lumbar flexion to minimize pain and symptoms while walking; this can lead to gait abnormalities.
Walking function is important for the maintenance of daily living activities. Gait disturbance is associated with poor health outcomes. In a gait cycle, the foot has two distinct phases: stance and swing. These gait phases can be analyzed as a proportion of the gait cycle and compared to normative values. Furthermore, with the use of more advanced systems and devices, it is also possible to assess asymmetries and gait variability in the pelvis and other structures during gait.
Technological advances have led to the emergence of reliable surface sensor technologies capable of gait analysis in the form of wearable accelerometers. These devices provide continuous and objective data streams, including parameters such as daily step count, step rate, and step length. Numerous studies have investigated walking function in LSS patients using various devices including motion capture systems, inertial sensors, accelerometers, wearable technologies, electromyography (EMG) and force platforms. In the study, walking impairment in LSS patients compared to healthy participants was a significant decrease in walking speed and step length, a slight decrease in cadence and a slight increase in step duration. As the double-step support and stance phase ratios increase, the swing phase ratio decreases. Walking asymmetry between the feet also increases in all phases including stance, swing and double-step support. In addition, LSS patients may exhibit gait variability with each step. The reasons for these changing gait patterns are thought to be radicular pain, muscle weakness, low walking tolerance and increased instability with lumbar spine posture in the lumbar extension position during walking.
Winter et al. evaluated the walking ability in daily life in patients with knee or hip osteoarthritis and lumbar spinal stenosis with the help of a wearable accelerometer device. As a result of the study, walking ability was found to be significantly lower in LSS individuals compared to healthy individuals.
Santos et al. examined the kinematic and spatiotemporal gait parameters in patients who underwent surgery with a diagnosis of disc herniation or lumbar stenosis before surgery and 1 and 6 months after surgery. As a result of the study, there was an increase in the pelvis, hip and knee range of motion (ROM) after surgery in the disc herniation group, while there was a decrease in the hip ROM values in the stenosis group. It was also observed that the pelvis and hip ROM of both groups remained smaller in the stance phase compared to the control group.
Papadakis et al. examined the changes in gait in patients with lumbar spinal stenosis with the help of an accelerometer before surgery and 6 and 12 months after surgery and showed that there was a significant decrease in the changes in gait in the postoperative period. It was observed that the improvement in the changes in gait was greater in the first month after surgery compared to the 6th and 12th months after surgery.
Purpose of the study:
The study was planned to compare the gait in healthy and patient groups in patients who underwent LSS surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar spinal stenosis patient group | – | –Assessment of Disability Status (Oswestry Disability Index) Pain Assessment (Visual Analog Scale-VAS) Quality of Life Assessment (SF-12) Evaluation of Gait Parameters: 10 Meter Walk Test-BTS G-Walk gait analysis system |
| healthy control group | – | –Quality of Life Assessment (SF-12) Evaluation of Gait Parameters: 10 Meter Walk Test-BTS G-Walk gait analysis system |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with spinal stenosis who have undergone surgery
Key inclusion criteria (5 listed)
- Between the ages of 20-65 and discharged from hospital,
- At least 6 weeks and at most 3 months after surgery,
- No other orthopedic and neurological problems,
- Able to communicate,
- Individuals who agree to participate in the study will be included in the study.
Key exclusion criteria (4 listed)
- Cognitive impairment,
- Other neurologic, psychiatric and/or orthopedic problems other than lumbar spinal stenosis,
- Medically unstable,
- Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Disability Status (Oswestry Disability Index)
Time frame: 10 minutes
It was developed to assess the degree of functional loss in low back pain. The Oswestry Disability Index (OSI), which was shown to be valid and reliable in Turkish in 2004, consists of 10 items. The items question the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleeping, the degree of change in pain, travel and social life. There are six statements under each item, which the patient marks as appropriate for his/her condition. The first statement is scored as "0", the sixth statement as "5". The score given by the participant to each question is added up. The total score received by the patient is divided by the maximum possible score of 50 points and multiplied by 100 to calculate the percentage. The maximum percentage is "100", the minimum percentage is "0". As the total percentage score increases, the level of disability also increases.
Pain Assessment (Visual Analog Scale-VAS)
Time frame: 2 minutes
It is a scale consisting of a single 10 cm line and the pain intensity of patients is evaluated with this scale. Participants are asked to mark the pain intensity at rest and during activity with a pencil on two separate 10 cm lines. The starting point on the scale is expressed as: no pain at all, the last point; the most severe pain encountered in life. When calculating, the distance between the marked point and the starting point is measured in cm with meters. An increase in the score indicates an increase in the intensity of the pain.
Quality of Life Assessment (SF-12)
Time frame: 5 minutes
It is a shortened and simplified form of the SF-36 Quality of Life Scale used to assess quality of life. Its Turkish validity and reliability were conducted by Soylu et al. in 2022. The results of the study show that the psychometric properties of the Turkish form of SF-12 are similar to the original version, and therefore it can be used in applications and research to be conducted in our country as an alternative to SF-36. It consists of a total of 12 questions. Each question has its own score. When calculating, 8 sub-items are calculated as percentages, including general health, physical function, physical role difficulty, emotional role difficulty, social function, pain, mental health and vitality. In percentage expressions ranging from 0 to 100, a high percentage indicates good health status.
10 Meter Walk Test
Time frame: 5 minutes
It is a test used to evaluate walking. A 10-meter area is determined in advance by the evaluator who will perform the test. The participant is asked to walk at his normal speed along the 10-meter area. When the participant is at the starting line, the stopwatch is started with the start command and the time is stopped when he crosses the finish line. In order to minimize the margin of error, two measurements are taken and the best value is recorded in meters/second (m/s).
BTS G-Walk gait analysis system
Time frame: 10 minutes
It is an analysis method that measures all important information such as spatio-temporal parameters of walking, general walking kinematics, spine kinematics and displays this in a computer environment. In the BTS G-Walk walking analysis system, the analysis port is attached to the patient's L5-S1 level and the results are transferred to the computer via the Bluetooth system. With this system; while comparing the walking analysis with normal values in the right and left extremities, it also allows the kinematic analysis of the pelvis to be performed in 3 planes. The resulting reports are created automatically and the system compares directly with the normal range results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Lumbar Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma ÖZ (5358510875, fatmaoz8499@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Disability Status (Oswestry Disability Index) (time frame: 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2025.