Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
- Conditions
- Degenerative Spine DiseaseSagittal Balance
- Interventions
- Diagnostic Test: Questionnaires and pain assessmentDiagnostic Test: Standing sagittal whole spine X-rayDiagnostic Test: Dynamic testDiagnostic Test: Muscle strength and body composition measurement
- Registration Number
- NCT06557837
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Muscle strength and body composition measurement Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging. Control group Questionnaires and pain assessment Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging. Control group Standing sagittal whole spine X-ray Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging. Patients with sagittal imbalance Questionnaires and pain assessment 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. Patients with sagittal imbalance Muscle strength and body composition measurement 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. Patients with sagittal imbalance Standing sagittal whole spine X-ray 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. Patients with sagittal imbalance Dynamic test 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. Control group Dynamic test Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging.
- Primary Outcome Measures
Name Time Method Change in AM-STS During Gait 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 C7-STS During Gait 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 SVA on X-ray During Walking 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 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.
- Secondary Outcome Measures
Name Time Method Change in PA During Gait Within 2 months from enrollment 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.
Change in LLA During Gait Within 2 months from enrollment 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.
Change in TKA During Gait Within 2 months from enrollment 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.
Change in GTA During Gait Within 2 months from enrollment 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.
Change in TK on X-ray During Walking At enrollment 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.
Additional Question: Does your body lean forward during gait? At enrollment 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.
Change in STA During Gait Within 2 months from enrollment 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.
Change in SS on X-ray During Walking At enrollment 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.
Change in PT on X-ray During Walking At enrollment 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.
Change in LL on X-ray During Walking At enrollment 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.
Additional Question: Is it hard for you to stand upright? At enrollment 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.
Maximum Isometric Strength of the Paraspinal Muscles Within 2 months from enrollment 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.
Maximum Isometric Strength of the Abdominal Muscles Within 2 months from enrollment 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.
Change in PI-LL on X-ray During Walking At enrollment 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.
Change in OD-HA on X-ray During Walking At enrollment 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).
Oswestry Disability Index (ODI) Questionnaire At enrollment 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.
Change in Angle of the hip on X-ray During Walking At enrollment 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.
Change in GT on X-ray During Walking At enrollment 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.
EQ-5D-5L Questionnaire At enrollment 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.
Visual Analogue Score (VAS) for low back pain At enrollment 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.
Body Fat Mass Within 2 months from enrollment Patients have their body fat mass measured using the InBody 720 device, with the results recorded in kilograms (kg).
Body Fat Percentage Within 2 months from enrollment Patients have their body fat percentage measured using the InBody 720 device, with the results recorded as a percentage (%).
Skeletal Muscle Mass Within 2 months from enrollment Patients have their skeletal muscle mass measured using the InBody 720 device, with the results recorded in kilograms (kg).
Total Body Water Within 2 months from enrollment Patients have their total body water measured using the InBody 720 device, with the results recorded in liters (L).
Extracellular Water / Total Body Water Within 2 months from enrollment Patients have their extracellular water versus total body water proportion measured using the InBody 720 device, with the results recorded as a ratio.
Trial Locations
- Locations (2)
Faculty of Sport, University of Ljubljana
🇸🇮Ljubljana, Slovenia
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia