Evaluation of Gait Impairment and Correlation in Patients With DCM (DCM-HFIMU)

June 20, 2025 updated by: Sungchul Huh, Pusan National University Yangsan Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

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 Backup

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

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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 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.
Device: Gait Analysis Using IMU Sensor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days before surgery, 10 days after surgery, and 30 days after surgery.
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.
10 days before surgery, 10 days after surgery, and 30 days after surgery.
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.
10 days before surgery, 10 days after surgery, and 30 days after surgery.
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.
10 days before surgery, 10 days after surgery, and 30 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Japanese Orthopaedic Association (mJOA) Score
Time Frame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
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.
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.
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.
10 days before surgery, 10 days after surgery, and 30 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Investigators

  • Principal Investigator: Sungchul Huh, PhD, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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