Clinical trial NCT06557837: Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
Official title: Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Spine Disease
Sagittal Balance
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: AO Foundation, AO Spine
First posted: 2024-08-16
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are selected from the outpatient clinic at the specialized orthopedic department of the 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in C7-STS During Gait
timeFrame: Within 2 months from enrollment
measure: Change in AM-STS During Gait
timeFrame: Within 2 months from enrollment
measure: Change in SVA on X-ray During Walking
timeFrame: At enrollment
measure: Change in CAM-HA on X-ray During Walking
timeFrame: At enrollment
Secondary outcomes:
measure: Change in PA During Gait
timeFrame: Within 2 months from enrollment
measure: Change in LLA During Gait
timeFrame: Within 2 months from enrollment
measure: Change in TKA During Gait
timeFrame: Within 2 months from enrollment
measure: Change in STA During Gait
timeFrame: Within 2 months from enrollment
measure: Change in GTA During Gait
timeFrame: Within 2 months from enrollment
measure: Change in PT on X-ray During Walking
timeFrame: At enrollment
measure: Change in SS on X-ray During Walking
timeFrame: At enrollment
measure: Change in LL on X-ray During Walking
timeFrame: At enrollment
measure: Change in TK on X-ray During Walking
timeFrame: At enrollment
measure: Change in PI-LL on X-ray During Walking
timeFrame: At enrollment
measure: Change in Angle of the hip on X-ray During Walking
timeFrame: At enrollment
measure: Change in OD-HA on X-ray During Walking
timeFrame: At enrollment
measure: Change in GT on X-ray During Walking
timeFrame: At enrollment
measure: Oswestry Disability Index (ODI) Questionnaire
timeFrame: At enrollment
measure: EQ-5D-5L Questionnaire
timeFrame: At enrollment
measure: Visual Analogue Score (VAS) for low back pain
timeFrame: At enrollment
measure: Additional Question: Is it hard for you to stand upright?
timeFrame: At enrollment
measure: Additional Question: Does your body lean forward during gait?
timeFrame: At enrollment
measure: Maximum Isometric Strength of the Paraspinal Muscles
timeFrame: Within 2 months from enrollment
measure: Maximum Isometric Strength of the Abdominal Muscles
timeFrame: Within 2 months from enrollment
measure: Skeletal Muscle Mass
timeFrame: Within 2 months from enrollment
measure: Body Fat Mass
timeFrame: Within 2 months from enrollment
measure: Body Fat Percentage
timeFrame: Within 2 months from enrollment
measure: Total Body Water
timeFrame: Within 2 months from enrollment
measure: Extracellular Water / Total Body Water
timeFrame: Within 2 months from enrollment
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Faculty of Sport, University of Ljubljana
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References: