Evaluation of Gait Impairment and Correlation in Patients With DCM

NCT06719375 | Not Yet Recruiting

• 1 other identifier: 2024-0053
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myelopathy Cervical

Outcome Measures

Primary Outcomes (4)

• Step Length

  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

  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

  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

  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 Outcomes (2)

• Modified Japanese Orthopaedic Association (mJOA) Score

  10 days before surgery, 10 days after surgery, and 30 days after surgery.

• Modified Ashworth Scale (MAS)

  10 days before surgery, 10 days after surgery, and 30 days after surgery.

Study Arms (1)

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

Interventions

Gait Analysis Using IMU Sensor DEVICE

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.

Degenerative Cervical Myelopathy (DCM) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Mandelli F, Zhang Y, Nuesch C, Ewald H, Aghlmandi S, Halbeisen F, Scharen S, Mundermann A, Netzer C. Gait function assessed using 3D gait analysis in patients with cervical spinal myelopathy before and after surgical decompression: a systematic review and meta-analysis. Spine J. 2024 Mar;24(3):406-416. doi: 10.1016/j.spinee.2023.09.030. Epub 2023 Oct 21.

  PMID: 37866484 BACKGROUND

Study Officials

• Sungchul Huh, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sungchul Huh, PhD

CONTACT

82-55-360-4250; dr.huhsc@gmail.com

Sungchul Huh, PhD

CONTACT

055-360-4250; dr.huhsc@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 50 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share