Evaluation of Gait Impairment and Correlation in Patients With DCM
ConditionMyelopathy Cervical
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPusan National University Yangsan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Gait Analysis Using IMU Sensor
DeviceInertial 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Degenerative Cervical Myelopathy (DCM) Patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 days before surgery, 10 days after surgery, and 30 days after surgery.2
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.
Time frame
10 days before surgery, 10 days after surgery, and 30 days after surgery.3
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.
Time frame
10 days before surgery, 10 days after surgery, and 30 days after surgery.4
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.
Time frame
10 days before surgery, 10 days after surgery, and 30 days after surgery.Secondary outcomes
1
Modified Japanese Orthopaedic Association (mJOA) Score
The mJOA score is used to assess neurological function in patients with Degenerative Cervical Myelopathy (DCM). This score evaluates motor dysfunction, sensory dysfunction, and bladder function. The score ranges from 0 (worst outcome) to 18 (best outcome), with higher scores indicating better neurological function.
Time frame
10 days before surgery, 10 days after surgery, and 30 days after surgery.2
Modified Ashworth Scale (MAS)
The MAS score is used to assess spasticity in patients with Degenerative Cervical Myelopathy (DCM). The scale ranges from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension). Lower scores indicate better outcomes, reflecting reduced spasticity.
Time frame
10 days before surgery, 10 days after surgery, and 30 days after surgery.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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