Evaluation of Gait Impairment and Correlation in Patients With DCM

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.

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.