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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital Capital Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Patients with the following single disease: degenerative scoliosis, coronal imbalance, lumbar spinal stenosis, lumbar disc herniation, spinal cord-type cervical spondylosis;
  2. Age ≥ 60 years, regardless of gender;
  3. Planned to undergo elective open spinal fusion surgery;
  4. Voluntarily participate in the study, understand and agree to the study content, and sign the informed consent form.

Exclusion Criteria:

  1. History of previous spinal surgery;
  2. 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;
  3. Suffering from severe cardiovascular, cerebral, liver, or kidney disease;

  4. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Gait analysis and surface electromyography analysis
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.
Other: Gait analysis and surface electromyography analysis
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.
Other: Gait analysis and surface electromyography analysis
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.
Other: Gait analysis and surface electromyography analysis
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.
Other: Gait analysis and surface electromyography analysis
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.
Other: Gait analysis and surface electromyography analysis
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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