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

Pusan National University Yangsan Hospital

Status: Not yet enrolling

Conditions: Myelopathy Cervical

Treatments: Device: Gait Analysis Using IMU Sensor

Study type: Observational

Funder types: Other

Identifiers

NCT06719375

2024-0053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Degenerative Cervical Myelopathy (DCM) Patients

Description:

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.

Treatment:

Device: Gait Analysis Using IMU Sensor