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Gait in Adult Patients With Cervical Spondylotic Myelopathy

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ClinicalTrials.gov Identifier: NCT03513679
Recruitment Status : Enrolling by invitation
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Cervical Spine Research Society
Information provided by (Responsible Party):
Ram Haddas, Texas Back Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Spondylotic Myelopathy Procedure: Surgical intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Cervical Decompression Surgery on Neuromuscular Control and Kinematics During Gait in Adult Patients With Cervical Spondylotic Myelopathy
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgical Group
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Procedure: Surgical intervention
Surgery to decompress the spinal cord, either with or without concurrent fusion

No Intervention: Control Group
Gait and balance testing to be administered once in healthy subjects



Primary Outcome Measures :
  1. Kinematic Variables Change assessed with human motion capture system [ Time Frame: Baseline; 3 and 12 months after surgery ]
    3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with CoM and head sway and displacement

  2. Kinetic Variables Change assessed with human motion capture system [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Vertical Ground Reaction Forces (GRF)

  3. Neuromuscular Variables Change assessed with an Electromyography [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Bilateral peak magnitude during the stance phase

  4. Spatio-Temporal Variables Change assessed with human motion capture system [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Walking speed


Secondary Outcome Measures :
  1. Patient Self-Reported Outcome Assessments Change [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Visual analog scale (VAS) for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain)

  2. Patient Self-Reported Outcome Assessments Change [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Oswestry Disability Index (ODI, version 2.1.a). Scale range from 0 (no pain) - 10 (most pain)

  3. Patient Self-Reported Outcome Assessments Change [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Neck Disability Index (NDI). Scale range from 0 (no pain) - 10 (most pain)

  4. Patient Self-Reported Outcome Assessments Change [ Time Frame: Baseline; 3 and 12 months after surgery ]
    Modified Japanese Orthopaedic Association scale (mJOA). Scale range from 0 (no pain) - 18 (most pain)



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 30 years and older
  2. Diagnosis of CSM with correlative imaging studies (MRI or CT-myelogram)
  3. Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds
  4. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513679


Locations
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United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
Sponsors and Collaborators
Texas Back Institute
Cervical Spine Research Society

Publications of Results:
Portney LG, Watkins MP. Foundation of clinical research: applications to practiceed. Upper Saddle River, New Jersy: Julie Levin Alexander, 2009.
Rhee JM, Riew KD, Spivak JM, et al. Cervical spondylotic myelopathy: including ossification of the posterior longitudinal ligamented. Rosemont, IL, 2006.
Dubousset J. Three-dimensional analysis of the scoliotic deformity. The pediatric spine: principles and practiceed. New York: Raven Press Ltd, 1994.
Haddas R, Belanger T, Ju KL, et al. Effect of Cervical Decompression Surgery on Gait in Adult Cervical Spondylotic Myelopathy Patients. North American Spine Society 32th Annual Meeting. Orlando, FL, 2017.
Haddas R, Ju K, Belanger T, et al. Effect of Cervical Decompression Surgery on Gait in Adult Cervical Spondylotic Myelopathy Patients. 24th International Meeting on Advanced Spine Techniques. Cape Town, South Africa, 2017.
Haddas R, Arakal R, Aghyarian S, et al. Gait Analysis on Adult Cervical Spondylotic Myelopathy Surgical Patients. 17th Annual Meeting of the International Society for the Advancement of Spine Surgery. Boca Raton, FL, USA, 2017.
Haddas R, Arakal R, Aghyarian S, et al. Gait Analysis on Adult Cervical Spondylotic Myelopathy Surgical Patients. Orthopaedic Research Society 2017 annual meeting. San Diego, CA, 2017.
Glantz SA. Primer of Biostatisticsed: McGraw-Hill Medical, 2011.

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Responsible Party: Ram Haddas, Director of Research, Texas Back Institute
ClinicalTrials.gov Identifier: NCT03513679     History of Changes
Other Study ID Numbers: TBIRF-CSRS
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases