Evaluation of Gait Impairment and Correlation in Patients With DCM

Официальное название

Evaluation of Gait Impairment and Correlation With Clinical Assessment Tools Before and After Surgery in Patients With Cervical Myelopathy Using Inertial Sensors

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Step Length [Срок оценки: 10 days before surgery, 10 days after surgery, and 30 days after surgery.]
• Walking Speed [Срок оценки: 10 days before surgery, 10 days after surgery, and 30 days after surgery.]
• Stride Length [Срок оценки: 10 days before surgery, 10 days after surgery, and 30 days after surgery.]
• Cadence [Срок оценки: 10 days before surgery, 10 days after surgery, and 30 days after surgery.]

Вторичные конечные точки (2)

• Modified Japanese Orthopaedic Association (mJOA) Score [Срок оценки: 10 days before surgery, 10 days after surgery, and 30 days after surgery.]
• Modified Ashworth Scale (MAS) [Срок оценки: 10 days before surgery, 10 days after surgery, and 30 days after surgery.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 15871480
• 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. PMID 34045643
• Maezawa 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. PMID 11845345
• Siasios 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. PMID 28192261
• Malone 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. PMID 24622959
• Williams 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. PMID 19109020
• McGinley 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. PMID 19013070
• Malone 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. PMID 22825630

Идентификаторы

NCT: NCT06719375 · 2024-0053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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