Gait in Adult Patients With Cervical Spondylotic Myelopathy

Status unconfirmed · Not applicable

Conditions studied: Cervical Spondylotic Myelopathy

In brief

The purpose of this study is to evaluate the effect of cervical decompression surgery on the biomechanics of the lower extremities and spine during balance and gait in patients with cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare these parameters to an asymptomatic control group. To test our hypothesis that cervical decompression will improve preexisting gait disturbance, a gait analysis using dynamic surface EMG, video motion capture, and force plate analysis will be used. Patients 30 to 70 years old will be eligible for the study. Thirty subjects diagnosed with symptomatic CSM and are deemed appropriate surgical candidates, along with 30 healthy subjects with no spine pathology, will be enrolled in this study. Exclusion criteria include any history of previous lumbar/thoracic surgery or lower extremity surgery, BMI greater than 35, or currently pregnant. Each subject from the surgical group will be evaluated on 3 different occasions: 1) 1 week before surgery, 2) 3 months postoperative, and 3) 12 months postoperative. Control subject will only be evaluated once. Bilateral trunk and lower extremity neuromuscular activity will be measured during a full gait cycle using dynamic surface EMG measurements. Human video motion capture cameras will collect lumbar spine and lower and upper extremity joint angles. Ground reaction forces (GRFs) will be collected from a 5 foot stretch of force platforms in order to define a full gait cycle.

Key facts

Study ID

NCT03513679

Run by

Texas Back Institute

People needed

100

Starts

2018-03-22

Expected to finish

2020-12-01

Last updated by the study team

2018-05-01

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 30 years and older
• Diagnosis of CSM with correlative imaging studies (MRI or CT-myelogram)
• Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds
• Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up

You may not qualify if…

• History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
• Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
• BMI higher than 35
• Neurological disorder (beside cervical spondylotic myelopathy), diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
• Usage of blood thinners
• Pregnant or wishing to become pregnant during the study

Where it is running

• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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