Clinical trial NCT06719375: Evaluation of Gait Impairment and Correlation With Clinical Assessment Tools Before and After Surgery in Patients With Cervical Myelopathy Using Inertial Sensors
Official title: Evaluation of Gait Impairment and Correlation With Clinical Assessment Tools Before and After Surgery in Patients With Cervical Myelopathy Using Inertial Sensors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myelopathy Cervical
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Step Length
timeFrame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
measure: Walking Speed
timeFrame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
measure: Stride Length
timeFrame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
measure: Cadence
timeFrame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Secondary outcomes:
measure: Modified Japanese Orthopaedic Association (mJOA) Score
timeFrame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
measure: Modified Ashworth Scale (MAS)
timeFrame: 10 days before surgery, 10 days after surgery, and 30 days after surgery.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 2. Mandelli, F., Zhang, Y., Nüesch, C., Ewald, H., Aghlmandi, S., Halbeisen, F., ... & Netzer, C. (2023). Gait function assessed using 3D gait analysis in patients with cervical spinal myelopathy before and after surgical decompression: a systematic review and meta-analysis. The Spine Journal. 3. Malone, A., Meldrum, D., & Bolger, C. (2012). Gait impairment in cervical spondylotic myelopathy: comparison with age-and gender-matched healthy controls. European spine journal, 21, 2456-2466. 4. McGinley, J. L., Baker, R., Wolfe, R., & Morris, M. E. (2009). The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait & posture, 29(3), 360-369. 5. Williams, G., Morris, M. E., Schache, A., & McCrory, P. (2009). Observational gait analysis in traumatic brain injury: accuracy of clinical judgment. Gait & Posture, 29(3), 454-459. 6. https://www.thespinejournalonline.com/article/S1529-9430(23)03440-X/fulltext 7. Malone, A., Meldrum, D., & Bolger, C. (2015). Three-dimensional gait analysis outcomes at 1 year following decompressive surgery for cervical spondylotic myelopathy. European Spine Journal, 24, 48-56. 8. Siasios, I. D. et al. The role of gait analysis in the evaluation of patients with cervical myelopathy: A literature review study. World Neurosurg. 101, 275-282 (2017). 9. Maezawa, Y., Uchida, K. & Baba, H. Gait analysis of spastic walking in patients with cervical compressive myelopathy. J. Orthop. Sci. 6, 378-384 (2001).
citation: Lee 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.