- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309926
Gait and Paraspinal sEMG in Degenerative Spinal Diseases (TDGKSEPDSD)
December 15, 2025 updated by: Xuanwu Hospital, Beijing
Comparative Analysis of Spatiotemporal Gait Parameters and Paraspinal Surface Electromyography Parameters in Degenerative Spinal Diseases: A Cross-Sectional Study Using Motion Capture and Electromyographic Ensemble Averaging
This cross-sectional observational study aims to quantitatively compare three-dimensional gait parameters, surface electromyography (EMG) patterns, and radiological parameters among patients with different degenerative spinal conditions-including lumbar disc herniation (LDH), lumbar spinal stenosis (LSS), lumbar sagittal imbalance (LSI), degenerative lumbar scoliosis (DLS), and cervical spondylotic myelopathy (CSM)-alongside a healthy control group.
The analysis focuses on spatiotemporal gait characteristics (step length, stride length, cadence), lower limb kinematics and kinetics (hip/knee/ankle joint angles, moments, and powers during stance and swing phases), and surface EMG amplitudes (thoracic erector spinae, multifidus, gluteus maximus, and rectus abdominis muscles) during standardized walking tasks.
Additionally, radiological parameters (e.g., pelvic incidence-lumbar lordosis mismatch, C2-C7 sagittal vertical axis, coronal Cobb angle) will be correlated with gait and muscle activation deviations.
The study employs motion capture systems, force plates, and high-density EMG to objectively differentiate disease-specific movement impairments.
Findings from this study may establish biomechanical and neuromuscular signatures for each degenerative condition, providing a framework for personalized rehabilitation strategies, gait retraining, and surgical outcome assessment in spinal disorders.
Comparative analysis with healthy controls will further elucidate pathological alterations in gait and muscle recruitment patterns caused by degenerative spinal diseases.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shibao Lu
- Phone Number: 18810728213
- Email: fzr15215486056@163.com
Study Contact Backup
- Name: Zuoran Fan
- Email: 1185867993@qq.com
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100053
- Xuanwu Hospital Capital Medical University
-
Contact:
- Zuoran Fan
- Phone Number: +8615215486056
- Email: fzr15215486056@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study included patients who required surgical treatment at the Spine Research Center for the Elderly at Xuanwu Hospital, Capital Medical University in Beijing, China, as well as healthy volunteers collected in the outpatient clinic.
Description
Inclusion Criteria:
- Patients with the following single disease: degenerative scoliosis, coronal imbalance, lumbar spinal stenosis, lumbar disc herniation, spinal cord-type cervical spondylosis;
- Age ≥ 60 years, regardless of gender;
- Planned to undergo elective open spinal fusion surgery;
- Voluntarily participate in the study, understand and agree to the study content, and sign the informed consent form.
Exclusion Criteria:
- History of previous spinal surgery;
- Combined with other neuromuscular diseases (such as Parkinson's disease), inflammatory diseases (such as ankylosing spondylitis), infectious diseases (such as spinal tuberculosis), sepsis, tumors, or lower limb joint diseases that may cause low back and lower limb pain, affecting physical activity;
- Suffering from severe cardiovascular, cerebral, liver, or kidney disease;
Suffering from mental illness, dementia, or unable to cooperate to complete clinical research.
- Skin rupture in the waist;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Degenerative Scoliosis Group
This group comprised elderly patients (>60 years old) diagnosed with degenerative lumbar scoliosis (DLS) (Cobb angle >20°).
Patients were excluded if they had concurrent neurological disorders, other spinal pathologies, or lower limb conditions that could influence gait mechanics.
Additionally, individuals with a history of spinal or lower limb surgery were also excluded to minimize confounding factors.
|
A comprehensive motion analysis system was employed to assess biomechanical parameters during functional tasks.
Ground reaction forces (GRFs) were measured using an instrumented force plate, while muscle activation patterns were recorded via surface electromyography (sEMG).
Three-dimensional kinematic data were concurrently captured using motion-capture cameras.
The standardized testing protocol consisted of: (1) quiet standing (30-second trial) and (2) three consecutive back-and-forth walking cycles (5-meter walkway), enabling the quantification of both static postural control and dynamic gait characteristics.
|
|
Sagittal Imbalance Group
This group comprised elderly patients (>60 years old) diagnosed with sagittal imbalance (PI-LL >20° , SVA > 4cm or PT > 20°).
Patients were excluded if they had concurrent neurological disorders, other spinal pathologies, or lower limb conditions that could influence gait mechanics.
Additionally, individuals with a history of spinal or lower limb surgery were also excluded to minimize confounding factors.
|
A comprehensive motion analysis system was employed to assess biomechanical parameters during functional tasks.
Ground reaction forces (GRFs) were measured using an instrumented force plate, while muscle activation patterns were recorded via surface electromyography (sEMG).
Three-dimensional kinematic data were concurrently captured using motion-capture cameras.
The standardized testing protocol consisted of: (1) quiet standing (30-second trial) and (2) three consecutive back-and-forth walking cycles (5-meter walkway), enabling the quantification of both static postural control and dynamic gait characteristics.
|
|
lumbar spinal stenosis Group
This group comprised elderly patients (≥60 years old) clinically diagnosed with lumbar spinal stenosis (LSS) through radiographic findings and symptomatology.
Exclusion criteria encompassed: (1) concurrent neurological disorders (e.g., peripheral neuropathy, cerebrovascular disease); (2) comorbid spinal pathologies (e.g., degenerative scoliosis, spondylolisthesis); (3) lower extremity conditions potentially impacting gait biomechanics (e.g., severe osteoarthritis, prior arthroplasty); and (4) any history of spinal or lower limb surgical interventions, thereby minimizing potential confounders.
|
A comprehensive motion analysis system was employed to assess biomechanical parameters during functional tasks.
Ground reaction forces (GRFs) were measured using an instrumented force plate, while muscle activation patterns were recorded via surface electromyography (sEMG).
Three-dimensional kinematic data were concurrently captured using motion-capture cameras.
The standardized testing protocol consisted of: (1) quiet standing (30-second trial) and (2) three consecutive back-and-forth walking cycles (5-meter walkway), enabling the quantification of both static postural control and dynamic gait characteristics.
|
|
Lumbar disc herniation Group
This group comprised elderly patients (≥60 years old) clinically diagnosed with Lumbar disc herniation (LDH) through radiographic findings and symptomatology.
Exclusion criteria encompassed: (1) concurrent neurological disorders (e.g., peripheral neuropathy, cerebrovascular disease); (2) comorbid spinal pathologies (e.g., degenerative scoliosis, spondylolisthesis); (3) lower extremity conditions potentially impacting gait biomechanics (e.g., severe osteoarthritis, prior arthroplasty); and (4) any history of spinal or lower limb surgical interventions, thereby minimizing potential confounders.
|
A comprehensive motion analysis system was employed to assess biomechanical parameters during functional tasks.
Ground reaction forces (GRFs) were measured using an instrumented force plate, while muscle activation patterns were recorded via surface electromyography (sEMG).
Three-dimensional kinematic data were concurrently captured using motion-capture cameras.
The standardized testing protocol consisted of: (1) quiet standing (30-second trial) and (2) three consecutive back-and-forth walking cycles (5-meter walkway), enabling the quantification of both static postural control and dynamic gait characteristics.
|
|
Cervical Spondylosis with Myelopathy Group
This group comprised elderly patients (≥60 years old) clinically diagnosed with Cervical Spondylosis with Myelopathy Group through radiographic findings and symptomatology.
Exclusion criteria encompassed: (1) concurrent neurological disorders (e.g., peripheral neuropathy, cerebrovascular disease); (2) comorbid spinal pathologies (e.g., degenerative scoliosis, spondylolisthesis); (3) lower extremity conditions potentially impacting gait biomechanics (e.g., severe osteoarthritis, prior arthroplasty); and (4) any history of spinal or lower limb surgical interventions, thereby minimizing potential confounders.
|
A comprehensive motion analysis system was employed to assess biomechanical parameters during functional tasks.
Ground reaction forces (GRFs) were measured using an instrumented force plate, while muscle activation patterns were recorded via surface electromyography (sEMG).
Three-dimensional kinematic data were concurrently captured using motion-capture cameras.
The standardized testing protocol consisted of: (1) quiet standing (30-second trial) and (2) three consecutive back-and-forth walking cycles (5-meter walkway), enabling the quantification of both static postural control and dynamic gait characteristics.
|
|
Healthy Volunteer Group
This group comprised healthy elderly patients (≥60 years old) .
Exclusion criteria encompassed: (1) concurrent neurological disorders (e.g., peripheral neuropathy, cerebrovascular disease); (2) comorbid spinal pathologies (e.g., degenerative scoliosis, LSS, LDH, spondylolisthesis); (3) lower extremity conditions potentially impacting gait biomechanics (e.g., severe osteoarthritis, prior arthroplasty); and (4) any history of spinal or lower limb surgical interventions, thereby minimizing potential confounders.
|
A comprehensive motion analysis system was employed to assess biomechanical parameters during functional tasks.
Ground reaction forces (GRFs) were measured using an instrumented force plate, while muscle activation patterns were recorded via surface electromyography (sEMG).
Three-dimensional kinematic data were concurrently captured using motion-capture cameras.
The standardized testing protocol consisted of: (1) quiet standing (30-second trial) and (2) three consecutive back-and-forth walking cycles (5-meter walkway), enabling the quantification of both static postural control and dynamic gait characteristics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Velocity
Time Frame: one week before surgery
|
velocity refers to the distance traveled by the human body per unit time during walking and is one of the core parameters for evaluating dynamic gait characteristics.
|
one week before surgery
|
|
Cadence
Time Frame: one week before surgery
|
Cadence is one of the core spatiotemporal parameters in three-dimensional gait analysis, referring to the number of steps per minute (Steps Per Minute, SPM), which reflects walking rhythm and movement efficiency.
|
one week before surgery
|
|
Stride time
Time Frame: one week before surgery
|
In three-dimensional gait analysis, stride time refers to the time interval between two consecutive initial contacts of the same heel, representing the duration required to complete a full stride (unit: seconds).
Its calculation encompasses both the stance phase and swing phase of a single lower limb, making it one of the core temporal parameters of the gait cycle.
|
one week before surgery
|
|
Stance time
Time Frame: one week before surgery
|
Stance Time is one of the key spatiotemporal parameters in gait analysis, referring to the period from the initial contact of a single foot with the ground to its complete toe-off.
It reflects the weight-bearing and stability performance of the lower limb during the walking cycle.
|
one week before surgery
|
|
Swing time
Time Frame: one week before surgery
|
The swing phase is a stage in the gait cycle, referring to the time interval from when the foot leaves the ground (toe-off) to when the same foot touches the ground again (heel strike).
|
one week before surgery
|
|
Stance phase
Time Frame: one week before surgery
|
The Stance Phase refers to the entire stage in the Gait Cycle when the foot is in contact with the ground, starting from Initial Contact (heel strike) and ending with Toe-Off (toe lift) of the same foot.
It accounts for approximately 60%~65% of a normal gait cycle (reduced to about 40% during running).
|
one week before surgery
|
|
Swing phase
Time Frame: one week before surgery
|
Swing Phase is a critical stage in the Gait Cycle, referring to the movement process from when the foot leaves the ground and swings forward until it makes contact with the ground again.
During this phase, the lower limb completes actions such as acceleration and deceleration in the air, as well as preparing for the next support phase.
In three-dimensional gait analysis, the Swing Phase is quantified using motion capture systems (such as marker points, force plates, and surface electromyography) to measure joint angles, muscle activity, and spatiotemporal parameters, providing objective data for clinical gait assessment.
|
one week before surgery
|
|
Single support phase
Time Frame: one week before surgery
|
Single Support Phase is a critical stage in the Gait Cycle, referring to the period when one foot fully bears the body weight while the other lower limb is in the Swing Phase.
|
one week before surgery
|
|
Double support phase
Time Frame: one week before surgery
|
The Double Support Phase is a crucial time stage in the gait cycle, referring to the moment during walking when both feet are simultaneously in contact with the ground.
This phase holds significant importance in gait analysis, particularly in 3D Gait Analysis, where it is used to assess balance, gait stability, and neuromuscular control.
|
one week before surgery
|
|
Stride length
Time Frame: one week before surgery
|
Stride Length refers to the horizontal distance between two consecutive points of contact by the same foot.
It is a crucial parameter in gait analysis for evaluating the walking cycle, particularly significant in clinical rehabilitation, sports medicine, and biomechanics research.
|
one week before surgery
|
|
Step length
Time Frame: one week before surgery
|
Step length refers to the horizontal distance between two consecutive ground contact points of the heel on the same side (i.e., the forward distance from the previous heel contact point to the next heel contact point when the left/right foot takes a step).
|
one week before surgery
|
|
Step Width
Time Frame: one week before surgery
|
Step Width is a crucial parameter in Gait Analysis, used to quantify gait stability and balance control during human walking.
It holds significant clinical value, particularly in fields such as neuromuscular disorders, fall risk assessment, and sports injury rehabilitation.
|
one week before surgery
|
|
Gait Deviation Index
Time Frame: one week before surgery
|
The Gait Deviation Index is a standardized metric used to quantitatively assess the degree of gait abnormalities, calculated based on data from 3D motion analysis systems.
It is widely applied in rehabilitation medicine, orthopedics, and neuroscience, particularly for gait analysis in patients with conditions such as cerebral palsy, stroke, and spinal cord injuries.
|
one week before surgery
|
|
Hip Range of Motion
Time Frame: one week before surgery
|
Hip joint range of motion refers to the dynamic angular changes of the hip joint in three planes of movement, quantitatively measured using a motion capture system during three-dimensional gait analysis (3D Gait Analysis).
It is a critical parameter for assessing gait abnormalities, hip joint function, and neuromuscular disorders.
|
one week before surgery
|
|
Knee Range of Motion
Time Frame: one week before surgery
|
Knee range of motion refers to the dynamic movement range of the knee joint in the sagittal, coronal, and transverse planes quantitatively measured by a motion capture system during three-dimensional gait analysis.
It is one of the core parameters for evaluating walking function, joint stability, and postoperative rehabilitation outcomes.
|
one week before surgery
|
|
Ankle Range of Motion
Time Frame: one week before surgery
|
Ankle range of motion (AROM) refers to the dynamic movement range of the ankle joint during the gait cycle, typically quantified and assessed in three dimensions: the sagittal plane (flexion-extension), the coronal plane (inversion-eversion), and the horizontal plane (internal-external rotation).
It holds significant importance for diagnosing gait abnormalities, monitoring rehabilitation outcomes, and surgical planning.
|
one week before surgery
|
|
Hip joint moment
Time Frame: one week before surgery
|
Hip joint moment refers to the biomechanical load acting on the hip joint during the gait cycle, reflecting the mechanical balance of muscles, ligaments, and bones around the joint.
In three-dimensional gait analysis, it is calculated using dynamic models, with units in newton-meters (N·m) or normalized to body weight multiples (N·m/kg).
|
one week before surgery
|
|
Knee joint moment
Time Frame: one week before surgery
|
Knee joint moment is a key dynamic parameter in gait analysis, referring to the rotational force (torque) acting on the knee joint during walking or movement, which reflects the mechanical load state of the muscles, ligaments, and bones around the knee joint.
|
one week before surgery
|
|
Ankle joint moment
Time Frame: one week before surgery
|
Ankle Joint Moment refers to the internal and external moments acting on the ankle joint in the sagittal, coronal, and horizontal planes, calculated through combined measurements using a 3D motion capture system and force plates during gait analysis.
It reflects the dynamic load state of the muscles, ligaments, and skeletal structures surrounding the ankle joint.
|
one week before surgery
|
|
Average EMG
Time Frame: one week before surgery
|
Average EMG (AEMG) refers to the average amplitude value of the electrical signals from the target muscle collected via surface electromyography (sEMG) after rectification and filtering during a gait cycle (or a specific time period) in three-dimensional gait analysis, reflecting the overall intensity of muscle activity.
|
one week before surgery
|
|
Integrated electromyography
Time Frame: one week before surgery
|
The integrated electromyography (iEMG) is a quantitative metric in surface electromyography (sEMG) analysis, referring to the cumulative sum of EMG signal amplitudes over a specific time period, reflecting the overall intensity of muscle activity.
In three-dimensional gait analysis, iEMG is commonly used to assess the synergistic activation patterns and fatigue levels of different muscles during the walking cycle.
|
one week before surgery
|
|
Root mean square
Time Frame: one week before surgery
|
The root mean square (RMS) average of surface electromyography is a time-domain analysis method used in surface electromyography (sEMG) signal processing to quantify the electrical activity intensity of muscles during specific movements (such as walking or running).
|
one week before surgery
|
|
The maximum root mean square of surface electromyography
Time Frame: one week before surgery
|
The maximum root mean square of surface electromyography (RMSmax) refers to the maximum activation intensity value (unit: μV or mV) of a specific muscle during the gait cycle, obtained by processing the muscle's electrical signals collected via surface electrodes using root mean square (RMS) analysis in three-dimensional gait analysis.
|
one week before surgery
|
|
Mean Power Frequency
Time Frame: one week before surgery
|
Mean Power Frequency (MPF) is one of the key indicators in the frequency domain analysis of surface electromyography (sEMG), reflecting the main frequency energy distribution of motor unit action potentials (MUAPs) during muscle contraction.
In 3D gait analysis, MPF is used to quantify muscle fatigue levels, neuromuscular control strategies, and functional movement states.
|
one week before surgery
|
|
Median Frequency
Time Frame: one week before surgery
|
The median frequency of surface electromyography (sEMG) refers to the frequency point in the power spectrum where the total energy is divided into two equal parts (i.e., 50% of the energy lies above and below this frequency) through spectral analysis of the EMG signal (typically using Fast Fourier Transform, FFT).
|
one week before surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: one week before surgery
|
VAS assessment uses a straight line or ruler about 10 centimeters long, with one end marked as 0 and the other as 10. 0 represents no pain, and 10 represents the most severe pain.
The patient marks a point on the line according to their pain perception, and this point represents the patient's pain intensity.
|
one week before surgery
|
|
Oswestry disability index
Time Frame: one week before surgery
|
The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability.
|
one week before surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 10, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
May 20, 2025
First Submitted That Met QC Criteria
December 15, 2025
First Posted (Actual)
December 30, 2025
Study Record Updates
Last Update Posted (Actual)
December 30, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Hernia
- Pathological Conditions, Signs and Symptoms
- Intervertebral Disc Displacement
- Spinal Stenosis
- Diagnostic Techniques and Procedures
- Diagnosis
- Population Characteristics
- Physical Examination
- Health
- Physical Fitness
- Gait
- Physical Functional Performance
- Gait Analysis
Other Study ID Numbers
- xuanwu_DSD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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