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Gait in Adult Patients With Cervical Spondylotic Myelopathy

Primary Purpose

Cervical Spondylotic Myelopathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical intervention
Sponsored by
Texas Back Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cervical Spondylotic Myelopathy

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Texas Back Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical Group

Control Group

Arm Description

Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery

Gait and balance testing to be administered once in healthy subjects

Outcomes

Primary Outcome Measures

Kinematic Variables Change assessed with human motion capture system
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
Kinetic Variables Change assessed with human motion capture system
Vertical Ground Reaction Forces (GRF)
Neuromuscular Variables Change assessed with an Electromyography
Bilateral peak magnitude during the stance phase
Spatio-Temporal Variables Change assessed with human motion capture system
Walking speed

Secondary Outcome Measures

Patient Self-Reported Outcome Assessments Change
Visual analog scale (VAS) for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain)
Patient Self-Reported Outcome Assessments Change
Oswestry Disability Index (ODI, version 2.1.a). Scale range from 0 (no pain) - 10 (most pain)
Patient Self-Reported Outcome Assessments Change
Neck Disability Index (NDI). Scale range from 0 (no pain) - 10 (most pain)
Patient Self-Reported Outcome Assessments Change
Modified Japanese Orthopaedic Association scale (mJOA). Scale range from 0 (no pain) - 18 (most pain)

Full Information

First Posted
February 14, 2018
Last Updated
April 30, 2018
Sponsor
Texas Back Institute
Collaborators
Cervical Spine Research Society
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1. Study Identification

Unique Protocol Identification Number
NCT03513679
Brief Title
Gait in Adult Patients With Cervical Spondylotic Myelopathy
Official Title
Effect of Cervical Decompression Surgery on Neuromuscular Control and Kinematics During Gait in Adult Patients With Cervical Spondylotic Myelopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Back Institute
Collaborators
Cervical Spine Research Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cervical spondylotic myelopathy (CSM) is a neurologic condition resulting from spinal cord compression caused by degenerative narrowing of the cervical spinal canal. CSM is most common after the age of 50 years, but the age of onset is variable depending on the degree of congenital spinal canal narrowing. Progressive degenerative changes in the cervical spine, such as disc bulges or herniations, facet hypertrophy, ligamentum flavum thickening, and degenerative vertebral spondylolisthesis, can all contribute to progressive spinal cord compression. The end result is chronic compression of the spinal cord and/or nerve roots leading to impaired blood flow, which can result in frank damage within the spinal cord itself. CSM is characterized by a wide variety of clinical presentations, which can include neck pain, numbness or weakness in the extremities, hand clumsiness, and, classically, gait disturbances. This typically manifests as difficulty with balance, but patients with more advanced myelopathy can also develop a stiff, spastic gait. Surgical treatment of CSM revolves around decompressing the spinal cord, either with or without concurrent fusion. Many surgical strategies have been proposed. Anterior surgical approaches include anterior cervical discectomy and fusion or anterior corpectomy and fusion. Posterior surgical approaches include laminectomy with or without fusion, or laminoplasty. The choice of surgical approach is specific to each patient based upon the extent and location of the pathology, the presence or absence of deformity or spinal instability, the sagittal alignment of the spine, the presence or absence of ossification of the posterior longitudinal ligament (OPLL), as well as other patient co-morbidity factors and surgeon preference. While there may be some debate as to when patients with radiographic cervical stenosis should undergo decompressive surgery, most surgeons would agree on surgery for patients with moderate or severe clinical myelopathy. Altered gait is frequently seen with CSM, and has been reported to be improved by surgical intervention. A stiff or spastic gait is also characteristic of CSM in its later stages. Many clinical studies have determined that patients with CSM have a slower gait speed, prolonged double support duration, and reduced cadence compared to healthy controls.Previous studies also identified reduced knee flexion during swing in the early stages of the disease, and, in more severe cases, decreased ankle plantar flexion at the terminal stance and reduced knee flexion during loading response. Upright stance and body stability depends on the vestibular, visual, and somatosensory systems.These systems contribute to the maintenance of postural control. The spinal cord, particularly the dorsal column, is an integral part of the somatosensory system.The dorsal columns relay the position and vibration sensations as well as play an important role in maintaining postural stability and conveying sensory information such as deep sensations to the lower limbs.When the dorsal column of the spinal cord is compressed, the functions of vibration sense, deep sensibility, and joint position sense are lost. CSM patients were found to have impaired knee proprioception when using electrogoniometer.22 A damaged spinal cord causes impaired body balance because of proprioceptive loss, and patients develop ataxia in the lower limbs. Jean Dubousset, first introduced the concept of the cone of economy and balance (COE) in 1994. The COE refers to a stable region of standing posture. The fundamental assumption is that swaying outside one's individual cone challenges the balance mechanisms and expends critical energy. Balance is defined as the ability of the human body to maintain its center of mass within the base of support with minimal postural sway. Sway is the movement of the COM in the horizontal plane when a person is standing in a static position. Balance efficiency is defined as the ability of the patients to maintain their COM within the COE with minimal sway and energy expenditure.Maintenance of balance requires coordination between the sensorineural and musculoskeletal systems. Very few studies have looked at functional balance in CSM patients. These studies used a stabilometer to measure center of gravity. During a 30 seconds balance test with closed eyes, CSM patients swayed significantly more and had greater postural instability compared to healthy controls. Neither of those studies reported on neuromuscular activity during a functional balance test. Haddas et al.was first to introduce a method to objectively quantify the COE and neuromuscular energy expenditure during a dynamic balance test. There is very little literature investigating the effect of surgical intervention on a CSM patient's balance and gait using human motion analysis both before and after surgery. In fact, there have not been any studies examining how surgical intervention for CSM can improve patients' balance and gait utilizing objective neuromuscular data as well as full body kinematic analysis. Additionally, none of the previous studies have been able to validate self-reported pain and functional outcome measures utilizing a human motion capture system and EMG. This study explores the effect of CSM on human balance and gait and will utilize kinematic balance and gait analyses to examine the dynamic range of motion of the spine and lower extremities, along with neuromuscular data from surface EMG to precisely define the timing and degree of spine and lower extremity muscle activation and peak activity, as well as measurements of ground reaction forces throughout the gait cycle. All of this will be compared pre- and post-operatively and also with a healthy control group in order to determine the extent to which CSM affects the biomechanics of and neuromuscular control during balance and gait and how this changes after surgical intervention. We will also be able to correlate these objective measures with patient self-reported pain and function based on commonly used outcome instruments. In summary, the purpose of this study is to explore the level of functional compromise, both objectively and with patient-reported outcome measures, in patients with CSM and to quantify the possible benefit of surgical intervention on the biomechanics and neuromuscular control of the spine and lower extremities as evaluated by balance and gait analyses using dynamic EMG, video motion capture, force plate analysis, and validated patient-reported outcome metrics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylotic Myelopathy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Group
Arm Type
Experimental
Arm Description
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Gait and balance testing to be administered once in healthy subjects
Intervention Type
Procedure
Intervention Name(s)
Surgical intervention
Intervention Description
Surgery to decompress the spinal cord, either with or without concurrent fusion
Primary Outcome Measure Information:
Title
Kinematic Variables Change assessed with human motion capture system
Description
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
Time Frame
Baseline; 3 and 12 months after surgery
Title
Kinetic Variables Change assessed with human motion capture system
Description
Vertical Ground Reaction Forces (GRF)
Time Frame
Baseline; 3 and 12 months after surgery
Title
Neuromuscular Variables Change assessed with an Electromyography
Description
Bilateral peak magnitude during the stance phase
Time Frame
Baseline; 3 and 12 months after surgery
Title
Spatio-Temporal Variables Change assessed with human motion capture system
Description
Walking speed
Time Frame
Baseline; 3 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Patient Self-Reported Outcome Assessments Change
Description
Visual analog scale (VAS) for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain)
Time Frame
Baseline; 3 and 12 months after surgery
Title
Patient Self-Reported Outcome Assessments Change
Description
Oswestry Disability Index (ODI, version 2.1.a). Scale range from 0 (no pain) - 10 (most pain)
Time Frame
Baseline; 3 and 12 months after surgery
Title
Patient Self-Reported Outcome Assessments Change
Description
Neck Disability Index (NDI). Scale range from 0 (no pain) - 10 (most pain)
Time Frame
Baseline; 3 and 12 months after surgery
Title
Patient Self-Reported Outcome Assessments Change
Description
Modified Japanese Orthopaedic Association scale (mJOA). Scale range from 0 (no pain) - 18 (most pain)
Time Frame
Baseline; 3 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Gait in Adult Patients With Cervical Spondylotic Myelopathy

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