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Procedure

Surgical Group for Cervical Myelopathy

N/A
Waitlist Available
Research Sponsored by Texas Back Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 3 and 12 months after surgery
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Cervical Myelopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 3 and 12 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 3 and 12 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kinematic Variables Change assessed with human motion capture system
Kinetic Variables Change assessed with human motion capture system
Electromyography
+1 more
Secondary outcome measures
Patient Self-Reported Outcome Assessments Change

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical GroupExperimental Treatment1 Intervention
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Group II: Control GroupActive Control1 Intervention
Gait and balance testing to be administered once in healthy subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical intervention
2015
N/A
~440

Find a Location

Who is running the clinical trial?

Texas Back InstituteLead Sponsor
6 Previous Clinical Trials
465 Total Patients Enrolled
Cervical Spine Research SocietyOTHER
3 Previous Clinical Trials
63 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Apr 2025