Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
NCT ID: NCT06557837
Last Updated: 2024-08-16
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
64 participants
OBSERVATIONAL
2023-09-01
2024-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Do patients with radiological parameters indicative of sagittal imbalance experience a statistically significant deterioration in sagittal balance during walking compared to a control group?
2. Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
3. Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
4. 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:
1. Complete questionnaires about their back pain and mobility.
2. Have X-ray images taken of their spine before and after walking for six minutes.
3. Undergo muscle strength tests and gait analysis using motion capture and electromyography (EMG) to monitor muscle activity while walking.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects
NCT03237039
Are Static and Dynamic Balance Tests A Criteria Showing Cognitive Impairments In the Elderly?
NCT05923385
Monitoring Combined Effect of Balance and Strengthening Exercises on Static and Dynamic Balance in Elderly Populations
NCT06835413
Development of a Static Balance Assessment Tool for High-Functioning Older Adults (KSVGH25-CT3-09)
NCT07300592
Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management
NCT03343769
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Questionnaires and pain assessment
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-ray
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 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 measurement
Participants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device.
Control group
Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging.
Questionnaires and pain assessment
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-ray
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 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 measurement
Participants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaires and pain assessment
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-ray
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 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 measurement
Participants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The main symptom is low back pain
* Age between 50-80 years.
Exclusion Criteria
* 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
50 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AO Foundation, AO Spine
OTHER
University Medical Centre Ljubljana
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Armand Dominik Škapin
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Sport, University of Ljubljana
Ljubljana, , Slovenia
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AOS-Startup-23-028
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0120-22/2023/47
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.