ClinicalTrials.gg
Not yet recruitingNCT07309926TDGKSEPDSDUpdated Dec 30, 2025

Gait and Paraspinal sEMG in Degenerative Spinal Diseases

An observational study in Adult Spinal Deformity, Degenerative Scoliosis and Sagittal Deformity, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Xuanwu Hospital, Beijing · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
60 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adult Spinal Deformity
  • Degenerative Scoliosis
  • Sagittal Deformity
  • Sagittal Imbalance
  • Coronal Vertical Axis
  • Lumbar Spinal Stenosis
  • Lumbar Disc Herniation
  • Cervical Spondylosis With Myelopathy
03

In context

Spinal Stenosis

458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 154 observational studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • OtherGait 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.

06

What researchers measure

Primary outcomes

  1. Velocity

    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.

    Time frame: one week before surgery

  2. Cadence

    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.

    Time frame: one week before surgery

  3. Stride time

    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.

    Time frame: one week before surgery

  4. Stance time

    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.

    Time frame: one week before surgery

  5. Swing time

    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).

    Time frame: one week before surgery

  6. Stance phase

    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).

    Time frame: one week before surgery

  7. Swing phase

    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.

    Time frame: one week before surgery

  8. Single support phase

    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.

    Time frame: one week before surgery

  9. Double support phase

    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.

    Time frame: one week before surgery

  10. Stride length

    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.

    Time frame: one week before surgery

  11. Step length

    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).

    Time frame: one week before surgery

  12. Step Width

    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.

    Time frame: one week before surgery

  13. Gait Deviation Index

    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.

    Time frame: one week before surgery

  14. Hip Range of Motion

    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.

    Time frame: one week before surgery

  15. Knee Range of Motion

    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.

    Time frame: one week before surgery

  16. Ankle Range of Motion

    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.

    Time frame: one week before surgery

  17. Hip joint moment

    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).

    Time frame: one week before surgery

  18. Knee joint moment

    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.

    Time frame: one week before surgery

  19. Ankle joint moment

    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.

    Time frame: one week before surgery

  20. Average EMG

    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.

    Time frame: one week before surgery

  21. Integrated electromyography

    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.

    Time frame: one week before surgery

  22. Root mean square

    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).

    Time frame: one week before surgery

  23. The maximum root mean square of surface electromyography

    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.

    Time frame: one week before surgery

  24. Mean Power Frequency

    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.

    Time frame: one week before surgery

  25. Median Frequency

    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).

    Time frame: one week before surgery

Secondary outcomes

  1. Visual Analogue Scale

    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.

    Time frame: one week before surgery

  2. Oswestry disability index

    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.

    Time frame: one week before surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2025; primary completion for Dec 2028, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2025
First posted
Dec 30, 2025
StartEst.
Dec 10, 2025
Primary completionEst.
Dec 1, 2028
CompletionEst.
Dec 1, 2029
Last update
Dec 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07309926
Responsible party
Sponsor
First posted
Dec 30, 2025
Start date
Dec 10, 2025 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Dec 30, 2025

Study contacts

Shibao Lu
Contact
fzr15215486056@163.com
18810728213
Zuoran Fan
Contact
1185867993@qq.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion