Degenerative Spine DiseaseNCT06557837
Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
An observational study of Degenerative Spine Disease and Sagittal Balance, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
Trial summary
The goal of this observational study is to analyze how spinal alignment changes when walking compared to standing still in adults aged 50 to 80 years who have sagittal imbalance. The main questions we aim to answer are: 1. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Spine Disease, Sagittal Balance
- What is being tested?
- Questionnaires and pain assessment, Standing sagittal whole spine X-ray and Dynamic test
- How many people
- 64 participants
- Where
- 2 sitesSlovenia
- Study dates
- 1 Sep 2023to 1 May 2024
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are selected from the outpatient clinic at the specialized orthopedic department of the University Medical Centre Ljubljana.
Who may be able to join
- Pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimeters
- The main symptom is low back pain
- Age between 50-80 years.
Who cannot join
- Symptoms of spinal stenosis
- Previous instrumented spinal surgery
- Cobb angle greater than 30°
- Symptoms of hip or knee arthrosis
- Symptoms of vascular intermittent claudication
- Cardio-pulmonary disease that lowers the patient's physical capability
- Neuromuscular disease
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Faculty of Sport, University of Ljubljana
Ljubljana, 1000
University Medical Centre Ljubljana
Ljubljana, 1000
About this study
The goal of this observational study is to analyze how spinal alignment changes when walking compared to standing still in adults aged 50 to 80 years who have sagittal imbalance. The main questions we aim to answer are:
- Do patients with radiological parameters indicative of sagittal imbalance experience a statistically significant deterioration in sagittal balance during walking compared to a control group?
- Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
- Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
- Is there a significant correlation between parameters obtained using established diagnostic methods and the degree of sagittal balance deterioration during walking?
Read more
Participants will be divided into two groups: patients with radiological indicators of sagittal imbalance and a control group of healthy individuals with back pain of similar age. Participants will:
- Complete questionnaires about their back pain and mobility.
- Have X-ray images taken of their spine before and after walking for six minutes.
- Undergo muscle strength tests and gait analysis using motion capture and electromyography (EMG) to monitor muscle activity while walking.
- Conditions
- Degenerative Spine Disease, Sagittal Balance
- Being tested
- Questionnaires and pain assessment, Standing sagittal whole spine X-ray, Dynamic test, Muscle strength and body composition measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and pain assessmentDiagnostic test
Participants complete two questionnaires: the Oswestry Disability Index (ODI) and the EQ-5D-5L. They also rate their low back pain using the Visual Analogue Score (VAS) scale and respond to two additional questions about their posture and gait.
Standing sagittal whole spine X-rayDiagnostic test
Participants undergo standard preoperative X-ray imaging of the entire spine to capture the upright posture. This imaging is conducted before and after 6-minute of continuous walking to compare changes in spino-pelvic and sagittal balance parameters.
Dynamic testDiagnostic test
With the dynamic test, we analyze body movements of participants during gait using 49 reflective markers placed on their bodies according to the Qualisys PAF package: Instituti Ortopedici Rizzoli (IOR) and 10 EMG electrodes on specific leg and back muscles. Participants walk for 6 minutes between two cones set 7 meters apart, while a 12-camera Qualisys Motion Capture System tracks marker movements for comprehensive kinematic analysis. Data are recorded at five key moments: standing before and after the test, and during three phases of gait (at the beginning, middle, and end). Participants are barefoot and dressed in underwear for accurate measurement. Static recordings before and after walking involve stepping on a tensiometric force plate to measure the center of gravity. Before the test, participants perform stretching exercises to ensure consistent preparation.
Muscle strength and body composition measurementDiagnostic test
Participants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sagittal imbalance | Patients that have pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimetres on X-ray imaging. Receives: Diagnostic Test: Questionnaires and pain assessment; Diagnostic Test: Standing sagittal whole spine X-ray; Diagnostic Test: Dynamic test; Diagnostic Test: Muscle strength and body composition measurement | |
| Control group | Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging. Receives: Diagnostic Test: Questionnaires and pain assessment; Diagnostic Test: Standing sagittal whole spine X-ray; Diagnostic Test: Dynamic test; Diagnostic Test: Muscle strength and body composition measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C7-STS During Gait
The change in the value of the C7 - sagittal trunk shift (C7-STS) will be measured at five points during the dynamic test. The measurement is in millimeters. C7-STS is defined as the distance between vertical line through the marker placed on spinous process C7 and the marker on spinous process L5.
Measured: Within 2 months from enrollment
Change in AM-STS During Gait
The change in the value of the Auditory meatus - sagittal trunk shift (AM-STS) will be measured at five points during the dynamic test. The measurement is in millimeters. AM-STS is defined as the distance between vertical line through the middle of the markers placed on each side of the head just above the ear and the middle of the markers placed on both greater trochanters.
Measured: Within 2 months from enrollment
Change in SVA on X-ray During Walking
A comparison of the Sagittal Vertical Axis (SVA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in millimeters. SVA is measured as the horizontal distance between a vertical line from the center of the C7 vertebra and the posterior superior corner of the sacrum on a sagittal X-ray.
Measured: At enrollment
Change in CAM-HA on X-ray During Walking
A comparison of the Center of Auditory Meatus to Hip Axis Plumbline (CAM-HA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in millimeters. CAM-HA is measured as the horizontal distance between a vertical line from the center of auditory meatus and the axis of the femoral heads on a sagittal X-ray.
Measured: At enrollment
Secondary outcomes (25)
Change in PA During Gait
The change in the value of the Pelvic angle (PA) will be measured at five points during the dynamic test. The measurement is in degrees. PA is defined as the angle between the markers placed on the posterior superior iliac spines and anterior superior iliac spines and horizontal plane.
Measured: Within 2 months from enrollment
Change in LLA During Gait
The change in the value of the Lumbar lordosis angle (LLA) will be measured at five points during the dynamic test. The measurement is in degrees. LLA is defined as the angle between the markers placed on spinous processes of L1, L3 and L5.
Measured: Within 2 months from enrollment
Change in TKA During Gait
The change in the value of the Thoracic kyphosis angle (TKA) will be measured at five points during the dynamic test. The measurement is in degrees. TKA is defined as the angle between the markers placed on spinous process of C7, spinous process of vertebra between the inferior edge of the scapulae and spinous process L1.
Measured: Within 2 months from enrollment
Change in STA During Gait
The change in the value of the Sagittal trunk angle (STA) will be measured at five points during the dynamic test. The measurement is in degrees. STA is defined as the angle between the line connecting the middle of the markers placed on each side of the head just above the ear and the middle of the markers placed on both greater trochanters and vertical line.
Measured: Within 2 months from enrollment
Change in GTA During Gait
The change in the value of the Global tilt angle (GTA) will be measured at five points during the dynamic test. The measurement is in degrees. GTA is defined as the angle between the markers placed on spinous process C7, L5 and the middle of the markers placed on both greater trochanters.
Measured: Within 2 months from enrollment
Change in PT on X-ray During Walking
A comparison of the Pelvic Tilt (PT) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. PT is defined as the angle between the vertical and the line connecting the center of the sacral endplate to the axis of the femoral heads on a sagittal X-ray.
Measured: At enrollment
Change in SS on X-ray During Walking
A comparison of the Sacral Slope (SS) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. SS is defined as the angle between a line tangent to the upper S1 endplate and horizontal line.
Measured: At enrollment
Change in LL on X-ray During Walking
A comparison of the Lumbar Lordosis (LL) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. LL is defined as the angle between the superior endplate of the first lumbar vertebra and the superior endplate of the first sacral vertebra.
Measured: At enrollment
Change in TK on X-ray During Walking
A comparison of the Thoracic Kyphosis (TK) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. TK is defined as the angle between the superior endplate of the first thoracic vertebra and the inferior endplate of the twelfth thoracic vertebra.
Measured: At enrollment
Change in PI-LL on X-ray During Walking
A comparison of the Pelvic Incidence-Lumbar Lordosis Deficit (PI-LL) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. PI-LL is defined as the difference between the pelvic incidence (PI) and lumbar lordosis (LL) angles.
Measured: At enrollment
Change in Angle of the hip on X-ray During Walking
A comparison of the Angle of the Hip in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. Angle of the Hip is defined as the angle between the line connecting the center of the sacral endplate to the axis of the femoral heads and the line drawn from the axis of the femoral heads along the femoral shaft.
Measured: At enrollment
Change in OD-HA on X-ray During Walking
A comparison of the Odontoid Hip Axis Angle (OD-HA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. OD-HA is defined as the angle between the vertical and the highest point of the odontoid process (dens) connecting to the center of the acetabulum (bi-coxo-femoral axis).
Measured: At enrollment
Change in GT on X-ray During Walking
A comparison of the Global Tilt (GT) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in degrees. GT is defined as the angle between a vertical line and a line drawn from the center of the C7 vertebra to the center of the sacral endplate.
Measured: At enrollment
Oswestry Disability Index (ODI) Questionnaire
The Oswestry Disability Index (ODI) is a questionnaire used to assess a patient's level of disability related to lower back pain. It is scored on a scale from 0 to 100%, where higher scores indicate worse outcomes.
Measured: At enrollment
EQ-5D-5L Questionnaire
The European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L) is a standardized questionnaire used to measure a patient's health-related quality of life across five dimensions and five levels. It is scored on a scale from -0,573 to 1, where higher scores indicate better outcomes.
Measured: At enrollment
Visual Analogue Score (VAS) for low back pain
The Visual Analogue Score (VAS) for low back pain is a tool used to measure patient's pain intensity in the lower back. It is scored on a scale from 0 to 10, where higher scores indicate worse outcomes.
Measured: At enrollment
Additional Question: Is it hard for you to stand upright?
The additional question "Is it hard for you to stand upright?" is assessed with a "yes" or "no" response, where "yes" indicates a worse outcome, signifying difficulty in maintaining an upright posture.
Measured: At enrollment
Additional Question: Does your body lean forward during gait?
The additional question "Does your body lean forward during gait?" is assessed with a "yes" or "no" response, where "yes" indicates a worse outcome, signifying a forward lean during walking.
Measured: At enrollment
Maximum Isometric Strength of the Paraspinal Muscles
The maximum isometric strength of the paraspinal muscles is measured using the Dr. Wolff BackCheck device. The muscle strength is recorded in Newton-meters (Nm) and then adjusted according to the participant's body weight for accurate comparison.
Measured: Within 2 months from enrollment
Maximum Isometric Strength of the Abdominal Muscles
The maximum isometric strength of the abdominal muscles is measured using the Dr. Wolff BackCheck device. The muscle strength is recorded in Newton-meters (Nm) and then adjusted according to the participant's body weight for accurate comparison.
Measured: Within 2 months from enrollment
Skeletal Muscle Mass
Patients have their skeletal muscle mass measured using the InBody 720 device, with the results recorded in kilograms (kg).
Measured: Within 2 months from enrollment
Body Fat Mass
Patients have their body fat mass measured using the InBody 720 device, with the results recorded in kilograms (kg).
Measured: Within 2 months from enrollment
Body Fat Percentage
Patients have their body fat percentage measured using the InBody 720 device, with the results recorded as a percentage (%).
Measured: Within 2 months from enrollment
Total Body Water
Patients have their total body water measured using the InBody 720 device, with the results recorded in liters (L).
Measured: Within 2 months from enrollment
Extracellular Water / Total Body Water
Patients have their extracellular water versus total body water proportion measured using the InBody 720 device, with the results recorded as a ratio.
Measured: Within 2 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spine DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Responsible party
- Principal investigator, Armand Dominik Škapin, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557837
- Sponsor's protocol ID
- 0120-22/2023/47
- Other IDs
- AOS-Startup-23-028
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 Aug 2024
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
- ClinicalTrials.gov ID
- NCT06557837
- Acronym / sponsor ID
- 0120-22/2023/47
- Conditions
- Degenerative Spine Disease, Sagittal Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 16 Aug 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.
The goal of this observational study is to analyze how spinal alignment changes when walking compared to standing still in adults aged 50 to 80 years who have sagittal imbalance. The main questions we aim to answer are:
- Do patients with radiological parameters indicative of sagittal imbalance experience a statistically significant deterioration in sagittal balance during walking compared to a control group?
- Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
- Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
- Is there a significant correlation between parameters obtained using established diagnostic methods and the degree of sagittal balance deterioration during walking?
Participants will be divided into two groups: patients with radiological indicators of sagittal imbalance and a control group of healthy individuals with back pain of similar age. Participants will:
- Complete questionnaires about their back pain and mobility.
- Have X-ray images taken of their spine before and after walking for six minutes.
- Undergo muscle strength tests and gait analysis using motion capture and electromyography (EMG) to monitor muscle activity while walking.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with sagittal imbalance | – | Diagnostic Test: Questionnaires and pain assessment, Diagnostic Test: Standing sagittal whole spine X-ray, Diagnostic Test: Dynamic test, Diagnostic Test: Muscle strength and body composition measurementPatients that have pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimetres on X-ray imaging. |
| Control group | – | Diagnostic Test: Questionnaires and pain assessment, Diagnostic Test: Standing sagittal whole spine X-ray, Diagnostic Test: Dynamic test, Diagnostic Test: Muscle strength and body composition measurementParticipants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are selected from the outpatient clinic at the specialized orthopedic department of the University Medical Centre Ljubljana.
Key inclusion criteria (3 listed)
- Pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimeters
- The main symptom is low back pain
- Age between 50-80 years.
Key exclusion criteria (7 listed)
- Symptoms of spinal stenosis
- Previous instrumented spinal surgery
- Cobb angle greater than 30°
- Symptoms of hip or knee arthrosis
- Symptoms of vascular intermittent claudication
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 |
|---|---|---|
| Questionnaires and pain assessmentParticipants complete two questionnaires: the Oswestry Disability Index (ODI) and the EQ-5D-5L. They also rate their low back pain using the Visual Analogue Score (VAS) scale and respond to two additional questions about their posture and gait. | Diagnostic test | Control group, Patients with sagittal imbalance |
| Standing sagittal whole spine X-rayParticipants undergo standard preoperative X-ray imaging of the entire spine to capture the upright posture. This imaging is conducted before and after 6-minute of continuous walking to compare changes in spino-pelvic and sagittal balance parameters. | Diagnostic test | Control group, Patients with sagittal imbalance |
| Dynamic testWith the dynamic test, we analyze body movements of participants during gait using 49 reflective markers placed on their bodies according to the Qualisys PAF package: Instituti Ortopedici Rizzoli (IOR) and 10 EMG electrodes on specific leg and back muscles. Participants walk for 6 minutes between two cones set 7 meters apart, while a 12-camera Qualisys Motion Capture System tracks marker movements for comprehensive kinematic analysis. Data are recorded at five key moments: standing before and after the test, and during three phases of gait (at the beginning, middle, and end). Participants are barefoot and dressed in underwear for accurate measurement. Static recordings before and after walking involve stepping on a tensiometric force plate to measure the center of gravity. Before the test, participants perform stretching exercises to ensure consistent preparation. | Diagnostic test | Control group, Patients with sagittal imbalance |
| Muscle strength and body composition measurementParticipants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device. | Diagnostic test | Control group, Patients with sagittal imbalance |
Primary outcome
Change in C7-STS During Gait
Time frame: Within 2 months from enrollment
The change in the value of the C7 - sagittal trunk shift (C7-STS) will be measured at five points during the dynamic test. The measurement is in millimeters. C7-STS is defined as the distance between vertical line through the marker placed on spinous process C7 and the marker on spinous process L5.
Change in AM-STS During Gait
Time frame: Within 2 months from enrollment
The change in the value of the Auditory meatus - sagittal trunk shift (AM-STS) will be measured at five points during the dynamic test. The measurement is in millimeters. AM-STS is defined as the distance between vertical line through the middle of the markers placed on each side of the head just above the ear and the middle of the markers placed on both greater trochanters.
Change in SVA on X-ray During Walking
Time frame: At enrollment
A comparison of the Sagittal Vertical Axis (SVA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in millimeters. SVA is measured as the horizontal distance between a vertical line from the center of the C7 vertebra and the posterior superior corner of the sacrum on a sagittal X-ray.
Change in CAM-HA on X-ray During Walking
Time frame: At enrollment
A comparison of the Center of Auditory Meatus to Hip Axis Plumbline (CAM-HA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in millimeters. CAM-HA is measured as the horizontal distance between a vertical line from the center of auditory meatus and the axis of the femoral heads on a sagittal X-ray.
25 secondary outcomes
Change in PA During Gait
Time frame: Within 2 months from enrollment
Change in LLA During Gait
Time frame: Within 2 months from enrollment
Change in TKA During Gait
Time frame: Within 2 months from enrollment
Change in STA During Gait
Time frame: Within 2 months from enrollment
Change in GTA During Gait
Time frame: Within 2 months from enrollment
Change in PT on X-ray During Walking
Time frame: At enrollment
Change in SS on X-ray During Walking
Time frame: At enrollment
Change in LL on X-ray During Walking
Time frame: At enrollment
Change in TK on X-ray During Walking
Time frame: At enrollment
Change in PI-LL on X-ray During Walking
Time frame: At enrollment
Change in Angle of the hip on X-ray During Walking
Time frame: At enrollment
Change in OD-HA on X-ray During Walking
Time frame: At enrollment
Change in GT on X-ray During Walking
Time frame: At enrollment
Oswestry Disability Index (ODI) Questionnaire
Time frame: At enrollment
EQ-5D-5L Questionnaire
Time frame: At enrollment
Visual Analogue Score (VAS) for low back pain
Time frame: At enrollment
Additional Question: Is it hard for you to stand upright?
Time frame: At enrollment
Additional Question: Does your body lean forward during gait?
Time frame: At enrollment
Maximum Isometric Strength of the Paraspinal Muscles
Time frame: Within 2 months from enrollment
Maximum Isometric Strength of the Abdominal Muscles
Time frame: Within 2 months from enrollment
Skeletal Muscle Mass
Time frame: Within 2 months from enrollment
Body Fat Mass
Time frame: Within 2 months from enrollment
Body Fat Percentage
Time frame: Within 2 months from enrollment
Total Body Water
Time frame: Within 2 months from enrollment
Extracellular Water / Total Body Water
Time frame: Within 2 months from enrollment
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 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Spine Disease and Sagittal Balance, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
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 3 inclusion and 7 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. 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?
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?
Change in C7-STS During Gait (time frame: Within 2 months from enrollment). The study lists 4 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 16 Aug 2024.