Myelopathy CervicalDCM-HFIMUNCT06719375
Evaluation of Gait Impairment and Correlation in Patients With DCM
An observational study of Myelopathy Cervical, run by Pusan National University Yangsan Hospital.
Trial summary
This study aims to evaluate gait impairment in patients with Degenerative Cervical Myelopathy (DCM) before and after surgery using an inertial measurement unit (IMU) sensor. By comparing IMU-derived gait parameters with traditional clinical assessment tools (e.g., Modified Ashworth Scale, mJOA, and GRASSP), the study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelopathy Cervical
- What is being tested?
- Gait Analysis Using IMU Sensor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2025
- How long will I take part?
- 50 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults aged 18 years or older who are diagnosed with cervical myelopathy and exhibit gait disturbances. Participants must be capable of walking at least 3 meters unassisted and have not undergone previous surgical treatment for cervical myelopathy. This population will be assessed using gait analysis and clinical evaluation tools to measure gait parameters and motor function. Individuals with severe respiratory or cardiac conditions, musculoskeletal issues affecting gait, or a history of neurological disorders impacting mobility will be excluded from the study.
Who may be able to join
- Age 18 years or older.
- Able to communicate and provide informed consent.
- Capable of walking at least 3 meters without assistance from others or walking aids.
- No prior surgical treatment for cervical myelopathy.
- Lower limb motor function score of 2 or higher on the mJOA scale.
Who cannot join
- Presence of severe respiratory or cardiac conditions that impede safe walking.
- Musculoskeletal issues, such as spinal deformities, affecting gait.
- History of neurological disorders affecting gait, including peripheral nerve injury, joint stiffness, stroke, traumatic brain injury, myelitis, or Parkinson's disease.
- Prior orthopedic or neurosurgical interventions that could impact gait.
- Cervical conditions resulting from trauma (acute fracture or acute disc herniation), tumor, or infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Gait Impairment and Correlation With Clinical Assessment Tools Before and After Surgery in Patients With Cervical Myelopathy Using Inertial Sensors
This study aims to evaluate gait impairment in patients with Degenerative Cervical Myelopathy (DCM) before and after surgery using an inertial measurement unit (IMU) sensor. By comparing IMU-derived gait parameters with traditional clinical assessment tools (e.g., Modified Ashworth Scale, mJOA, and GRASSP), the study seeks to determine the effectiveness and reliability of IMU sensors for assessing and monitoring gait improvement and neurological recovery in DCM patients. This study is conducted outside the United States and does not involve interventions or devices subject to U.S. FDA regulation.
Read the detailed description
This observational study will investigate the correlation between gait parameters measured with an IMU sensor and established clinical evaluation tools for patients with Degenerative Cervical Myelopathy (DCM). The primary aim is to quantify gait impairments before and after surgical intervention and to verify the IMU sensor's utility as a quantitative assessment tool. The study will recruit both DCM patients and a control group to evaluate the sensitivity of the IMU sensor in detecting fine motor and gait differences. Outcomes will be analyzed using statistical comparisons of pre- and post-surgery measurements, with specific focus on gait speed, cadence, stride length, and spasticity. The anticipated goal is to validate the IMU sensor as a reliable alternative to existing clinical tools, facilitating early detection of gait impairment and monitoring post-surgical improvement in DCM patients. This study is conducted entirely outside the United States and does not involve interventions or devices subject to U.S. FDA regulation. The devices and procedures used in this study are approved by local regulatory authorities in the country where the study is conducted. The study complies with applicable international and local guidelines rather than U.S. FDA requirements.
- Conditions
- Myelopathy Cervical
- Being tested
- Gait Analysis Using IMU Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Analysis Using IMU SensorDevice
Inertial Measurement Unit (IMU) sensor-based 3D gait analysis to assess spasticity and gait impairment. This intervention aims to provide quantitative data on gait parameters in DCM patients before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Degenerative Cervical Myelopathy (DCM) Patients | Patients diagnosed with Degenerative Cervical Myelopathy (DCM) scheduled for surgery. This group will undergo gait analysis and clinical assessments at three time points: 10 days pre-surgery, 10 days post-surgery, and 30 days post-surgery. Receives: Device: Gait Analysis Using IMU Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length
Step length is measured in centimeters (cm) to independently evaluate the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Step length is defined as the distance covered between two successive placements of the same foot and is a critical parameter to assess balance and mobility.
Measured: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Walking Speed
Walking speed is measured in kilometers per hour (km/h) to independently assess the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Walking speed evaluates the efficiency of ambulation over a defined distance and is a vital measure of functional mobility.
Measured: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Stride Length
Stride length is measured in centimeters (cm) to independently evaluate the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Stride length is defined as the distance covered in one complete gait cycle and provides insights into the patient's walking stability.
Measured: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Cadence
Cadence is measured in steps per minute (steps/min) to independently assess the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Cadence represents the number of steps taken per minute and is used to analyze walking rhythm and patterns.
Measured: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Secondary outcomes (2)
Modified Japanese Orthopaedic Association (mJOA) Score
The mJOA score is used to assess neurological function in patients with Degenerative Cervical Myelopathy (DCM). This score evaluates motor dysfunction, sensory dysfunction, and bladder function. The score ranges from 0 (worst outcome) to 18 (best outcome), with higher scores indicating better neurological function.
Measured: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Modified Ashworth Scale (MAS)
The MAS score is used to assess spasticity in patients with Degenerative Cervical Myelopathy (DCM). The scale ranges from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension). Lower scores indicate better outcomes, reflecting reduced spasticity.
Measured: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Myelopathy CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 50 Days
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sungchul Huh, Pusan National University Yangsan Hospital
- Investigators
- Sungchul Huh, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719375
- Sponsor's protocol ID
- 2024-0053
- Acronym
- DCM-HFIMU
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) from this study will not be shared to protect the privacy and confidentiality of participants. Due to the sensitive nature of the medical data involved, and to comply with institutional policies and ethical standards, data sharing is restricted to ensure the security and anonymity of participant information.
Publications
Moorthy RK, Bhattacharji S, Thayumanasamy G, Rajshekhar V. Quantitative changes in gait parameters after central corpectomy for cervical spondylotic myelopathy. J Neurosurg Spine. 2005 Apr;2(4):418-24. doi: 10.3171/spi.2005.2.4.0418.
PubMed 15871480Lee DH, Yoo JY, Cho JH, Hwang CJ, Lee CS, Kim C, Ha JK, Park KB. Subclinical gait disturbance and postoperative gait improvement in patients with degenerative cervical myelopathy. Sci Rep. 2021 May 27;11(1):11179. doi: 10.1038/s41598-021-90884-2.
PubMed 34045643Maezawa Y, Uchida K, Baba H. Gait analysis of spastic walking in patients with cervical compressive myelopathy. J Orthop Sci. 2001;6(5):378-84. doi: 10.1007/s007760170002.
PubMed 11845345Siasios ID, Spanos SL, Kanellopoulos AK, Fotiadou A, Pollina J, Schneider D, Becker A, Dimopoulos VG, Fountas KN. The Role of Gait Analysis in the Evaluation of Patients with Cervical Myelopathy: A Literature Review Study. World Neurosurg. 2017 May;101:275-282. doi: 10.1016/j.wneu.2017.01.122. Epub 2017 Feb 9.
PubMed 28192261Malone A, Meldrum D, Bolger C. Three-dimensional gait analysis outcomes at 1 year following decompressive surgery for cervical spondylotic myelopathy. Eur Spine J. 2015 Jan;24(1):48-56. doi: 10.1007/s00586-014-3267-1. Epub 2014 Mar 13.
PubMed 24622959Williams G, Morris ME, Schache A, McCrory P. Observational gait analysis in traumatic brain injury: accuracy of clinical judgment. Gait Posture. 2009 Apr;29(3):454-9. doi: 10.1016/j.gaitpost.2008.11.005. Epub 2008 Dec 23.
PubMed 19109020McGinley JL, Baker R, Wolfe R, Morris ME. The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait Posture. 2009 Apr;29(3):360-9. doi: 10.1016/j.gaitpost.2008.09.003. Epub 2008 Nov 13.
PubMed 19013070Malone A, Meldrum D, Bolger C. Gait impairment in cervical spondylotic myelopathy: comparison with age- and gender-matched healthy controls. Eur Spine J. 2012 Dec;21(12):2456-66. doi: 10.1007/s00586-012-2433-6. Epub 2012 Jul 24.
PubMed 22825630Mandelli F, Zhang Y, Nuesch C, Ewald H, Aghlmandi S, Halbeisen F, Scharen S, Mundermann A, Netzer C. Gait function assessed using 3D gait analysis in patients with cervical spinal myelopathy before and after surgical decompression: a systematic review and meta-analysis. Spine J. 2024 Mar;24(3):406-416. doi: 10.1016/j.spinee.2023.09.030. Epub 2023 Oct 21.
PubMed 37866484
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gait Impairment and Correlation With Clinical Assessment Tools Before and After Surgery in Patients With Cervical Myelopathy Using Inertial Sensors
- ClinicalTrials.gov ID
- NCT06719375
- Acronym / sponsor ID
- DCM-HFIMU / 2024-0053
- Conditions
- Myelopathy Cervical
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate gait impairment in patients with Degenerative Cervical Myelopathy (DCM) before and after surgery using an inertial measurement unit (IMU) sensor. By comparing IMU-derived gait parameters with traditional clinical assessment tools (e.g., Modified Ashworth Scale, mJOA, and GRASSP), the study seeks to determine the effectiveness and reliability of IMU sensors for assessing and monitoring gait improvement and neurological recovery in DCM patients. This study is conducted outside the United States and does not involve interventions or devices subject to U.S. FDA regulation.
Detailed description
This observational study will investigate the correlation between gait parameters measured with an IMU sensor and established clinical evaluation tools for patients with Degenerative Cervical Myelopathy (DCM). The primary aim is to quantify gait impairments before and after surgical intervention and to verify the IMU sensor's utility as a quantitative assessment tool. The study will recruit both DCM patients and a control group to evaluate the sensitivity of the IMU sensor in detecting fine motor and gait differences. Outcomes will be analyzed using statistical comparisons of pre- and post-surgery measurements, with specific focus on gait speed, cadence, stride length, and spasticity. The anticipated goal is to validate the IMU sensor as a reliable alternative to existing clinical tools, facilitating early detection of gait impairment and monitoring post-surgical improvement in DCM patients. This study is conducted entirely outside the United States and does not involve interventions or devices subject to U.S. FDA regulation. The devices and procedures used in this study are approved by local regulatory authorities in the country where the study is conducted. The study complies with applicable international and local guidelines rather than U.S. FDA requirements.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 50 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degenerative Cervical Myelopathy (DCM) Patients | – | Device: Gait Analysis Using IMU SensorPatients diagnosed with Degenerative Cervical Myelopathy (DCM) scheduled for surgery. This group will undergo gait analysis and clinical assessments at three time points: 10 days pre-surgery, 10 days post-surgery, and 30 days post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults aged 18 years or older who are diagnosed with cervical myelopathy and exhibit gait disturbances. Participants must be capable of walking at least 3 meters unassisted and have not undergone previous surgical treatment for cervical myelopathy. This population will be assessed using gait analysis and clinical evaluation tools to measure gait parameters and motor function. Individuals with severe respiratory or cardiac conditions, musculoskeletal issues affecting gait, or a history of neurological disorders impacting mobility will be excluded from the study.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Able to communicate and provide informed consent.
- Capable of walking at least 3 meters without assistance from others or walking aids.
- No prior surgical treatment for cervical myelopathy.
- Lower limb motor function score of 2 or higher on the mJOA scale.
Key exclusion criteria (5 listed)
- Presence of severe respiratory or cardiac conditions that impede safe walking.
- Musculoskeletal issues, such as spinal deformities, affecting gait.
- History of neurological disorders affecting gait, including peripheral nerve injury, joint stiffness, stroke, traumatic brain injury, myelitis, or Parkinson's disease.
- Prior orthopedic or neurosurgical interventions that could impact gait.
- Cervical conditions resulting from trauma (acute fracture or acute disc herniation), tumor, or infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Analysis Using IMU SensorInertial Measurement Unit (IMU) sensor-based 3D gait analysis to assess spasticity and gait impairment. This intervention aims to provide quantitative data on gait parameters in DCM patients before and after surgery. | Device | Degenerative Cervical Myelopathy (DCM) Patients |
Primary outcome
Step Length
Time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Step length is measured in centimeters (cm) to independently evaluate the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Step length is defined as the distance covered between two successive placements of the same foot and is a critical parameter to assess balance and mobility.
Walking Speed
Time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Walking speed is measured in kilometers per hour (km/h) to independently assess the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Walking speed evaluates the efficiency of ambulation over a defined distance and is a vital measure of functional mobility.
Stride Length
Time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Stride length is measured in centimeters (cm) to independently evaluate the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Stride length is defined as the distance covered in one complete gait cycle and provides insights into the patient's walking stability.
Cadence
Time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Cadence is measured in steps per minute (steps/min) to independently assess the gait characteristics of patients with Degenerative Cervical Myelopathy (DCM). Cadence represents the number of steps taken per minute and is used to analyze walking rhythm and patterns.
2 secondary outcomes
Modified Japanese Orthopaedic Association (mJOA) Score
Time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Modified Ashworth Scale (MAS)
Time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 15871480Moorthy RK, Bhattacharji S, Thayumanasamy G, Rajshekhar V. Quantitative changes in gait parameters after central corpectomy for cervical spondylotic myelopathy. J Neurosurg Spine. 2005 Apr;2(4):418-24. doi: 10.3171/spi.2005.2.4.0418.
- Background: PubMed 34045643Lee DH, Yoo JY, Cho JH, Hwang CJ, Lee CS, Kim C, Ha JK, Park KB. Subclinical gait disturbance and postoperative gait improvement in patients with degenerative cervical myelopathy. Sci Rep. 2021 May 27;11(1):11179. doi: 10.1038/s41598-021-90884-2.
- Background: PubMed 11845345Maezawa Y, Uchida K, Baba H. Gait analysis of spastic walking in patients with cervical compressive myelopathy. J Orthop Sci. 2001;6(5):378-84. doi: 10.1007/s007760170002.
- Background: PubMed 28192261Siasios ID, Spanos SL, Kanellopoulos AK, Fotiadou A, Pollina J, Schneider D, Becker A, Dimopoulos VG, Fountas KN. The Role of Gait Analysis in the Evaluation of Patients with Cervical Myelopathy: A Literature Review Study. World Neurosurg. 2017 May;101:275-282. doi: 10.1016/j.wneu.2017.01.122. Epub 2017 Feb 9.
- Background: PubMed 24622959Malone A, Meldrum D, Bolger C. Three-dimensional gait analysis outcomes at 1 year following decompressive surgery for cervical spondylotic myelopathy. Eur Spine J. 2015 Jan;24(1):48-56. doi: 10.1007/s00586-014-3267-1. Epub 2014 Mar 13.
- Background: PubMed 19109020Williams G, Morris ME, Schache A, McCrory P. Observational gait analysis in traumatic brain injury: accuracy of clinical judgment. Gait Posture. 2009 Apr;29(3):454-9. doi: 10.1016/j.gaitpost.2008.11.005. Epub 2008 Dec 23.
- Background: PubMed 19013070McGinley JL, Baker R, Wolfe R, Morris ME. The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait Posture. 2009 Apr;29(3):360-9. doi: 10.1016/j.gaitpost.2008.09.003. Epub 2008 Nov 13.
- Background: PubMed 22825630Malone A, Meldrum D, Bolger C. Gait impairment in cervical spondylotic myelopathy: comparison with age- and gender-matched healthy controls. Eur Spine J. 2012 Dec;21(12):2456-66. doi: 10.1007/s00586-012-2433-6. Epub 2012 Jul 24.
- Background: PubMed 37866484Mandelli F, Zhang Y, Nuesch C, Ewald H, Aghlmandi S, Halbeisen F, Scharen S, Mundermann A, Netzer C. Gait function assessed using 3D gait analysis in patients with cervical spinal myelopathy before and after surgical decompression: a systematic review and meta-analysis. Spine J. 2024 Mar;24(3):406-416. doi: 10.1016/j.spinee.2023.09.030. Epub 2023 Oct 21.
- Individual participant dataSharing planned: No. The individual participant data (IPD) from this study will not be shared to protect the privacy and confidentiality of participants. Due to the sensitive nature of the medical data involved, and to comply with institutional policies and ethical standards, data sharing is restricted to ensure the security and anonymity of participant information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sungchul Huh, PhD principal investigator
Pusan National University Yangsan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy Cervical, run by Pusan National University Yangsan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungchul Huh, PhD (82-55-360-4250, dr.huhsc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length (time frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06719375, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.