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Postural Stability in Cervical Spinal Myelopathy

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ClinicalTrials.gov Identifier: NCT03810781
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Temple University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from rigors of military service. Balance and posturography are negatively affected in CSM, but require expensive equipment, and extensive training of personnel for data acquisition and interpretation. The Virtual Environment TBI Screen (VETS) is a simple and inexpensive construct that could be implemented as an aid in diagnosis and as an objective means to compare treatment modalities and track recovery. The goal for the SPiRE is to generate the critical data to support rigorous Merit studies of posturography for assessments of clinical course in the treatment and rehabilitation of CSM. The investigators' ultimate goal, if the SPiRE is successful, is to phase in objective posturography assessments as VA standard of care in CSM.

Condition or disease
Cervical Spondylotic Myelopathy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Postural Stability in Subjects With Myelopathy Using a Portable Virtual Reality Balance Protocol
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Cervical Spondylotic Myelopathy (CSM)
Degenerative cervical myelopathy, encapsulates a cascade of events leading to significant degenerative changes in discs, formation of osteophytes, facet hypertrophy, calcification of the posterior longitudinal ligament and ligamentous flavum with resultant canal stenosis and segmental instability.



Primary Outcome Measures :
  1. Virtual Environment TBI System (VETS) assessment of Static Posturography [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    The postural stability task involves six conditions during which veterans are instructed to look straight ahead and maintain an upright stance as stably as possible. Veterans are barefooted with feet comfortably placed ~25 cm apart. The six conditions are (1) Eyes Open (EO) Firm (2) Eyes Closed (EC) Firm, (3) Dynamic Scene (DYN) Firm, (4) EO Foam, (5) EC Foam, and (6) DYN Foam. Each condition is tested three times with the average center of pressure (COP) sway area used as a index of stability for that condition.

  2. Change in Posturography [ Time Frame: Presurgery compared to 2 weeks, 6 weeks, and 6 months post-surgery. The Post-surgery endpoints are normally scheduled clinical follow ups. ]
    It is expected that posturography, especially that from FOAM and EC conditions will be improved be surgical relief. This is a within comparison of veterans with CSM and receiving surgical relief through widening of the chord.


Secondary Outcome Measures :
  1. Nurick Scale [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    The Nurick scale is a 6-grade ordinal scale assessing gait impairment, with grades ranging from 0 (signs and symptoms of root involvement but no evidence of spinal cord disease) to 5 (chair bound or bedridden). The aggregate value of the Nurick scale will be related to posturography.

  2. Neck Disability Index (NDI) [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    The NDI is a 10-item questionnaire addressing function activities (personal care, lifting, reading, work, driving, sleeping, and recreation), pain intensity, concentration, and headache. For each item, patients make their ratings on a 6-point Likert scale with values 0 = no disability and 5 = complete disability. Summed scores for each category are multiplied by 2 to give a total NDI score ranging from 0-100. NDI will be related to VETS posturography to determine the sensitivity of standing posture to degree of disability.

  3. Short Form-36 version 2 (SF-36v2) [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    The SF-36v2 is a general health survey that includes mental and physical component scores to measure functional status and overall quality of life. The instrument includes 8 scales: physical functioning, role limitations physical pain, bodily pain, general health perceptions, vitality, social functioning, role limitations, emotional health, and mental health. The higher the score the more limitations. The total scale will be used to determine the sensitivity of VETS posturography to quality of life.

  4. EC FIRM/EO FIRM ratio [ Time Frame: PreSurgery ]
    From the VETS, a ratio corresponding to the Rhomberg ratio of COP sway will be used to determine the degree static posture depends on visual input.

  5. EO FOAM/EO FIRM [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    From the VETS, a ratio of COP sway will be used to determine the degree static posture is affected by reduced proprioception.

  6. EC FOAM/EO FOAM ratio [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    From the VETS, a ratio of COP sway will be used to determine the degree loss of visual information compounds reduced proprioception in static balance.

  7. DYN FOAM/DYN FIRM ratio [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    From the VETS, a ratio of COP sway to determine the roll vection is induced by loss of proprioception.

  8. DYN FIRM/ EO FIRM ratio [ Time Frame: PreSurgery compared to otherwise healthy veterans ]
    From the VETS, a ration of COP sway to determine the degree roll vection is induced.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
US Veterans.
Criteria

Inclusion Criteria:

Patients in the CSM group will be selected based on clinical criteria. Inclusion criteria for the CSM group are:

  • symptoms of myelopathy in upper and lower extremities and stenosis of the cervical spine demonstrated by MRI or myelography
  • lower extremity muscle strength of 4 as quantified by manual muscle test (MMT) 36 or above
  • ability to stand without support with eyes closed for 30 s or more
  • Veterans in the control group will be recruited from the SVAMC and surrounding community using printed advertisements

Exclusion Criteria:

Exclusion criteria for all study participants are:

  • presence of lower extremity or lumbar spine disease
  • peripheral neuropathy
  • history of other neurological disorder
  • inability to stand in an upright position with both feet together and eyes closed
  • Although the SVAMC population is predominately Caucasian and male, every effort will be made to recruit minorities and women
  • The proposed study will neither target for recruitment nor will the investigators exclude pregnant women

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): NCT03810781


Contacts
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Contact: Richard J Servatius, PhD (315) 425-4870 Richard.Servatius@va.gov

Locations
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United States, New York
Syracuse VA Medical Center, Syracuse, NY Recruiting
Syracuse, New York, United States, 13210
Contact: Richard J Servatius, PhD    315-425-4870    Richard.Servatius@va.gov   
Contact: Richard J Servatius, PhD    (315) 425-4870    Richard.Servatius@va.gov   
Principal Investigator: Richard J. Servatius, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Temple University
Investigators
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Principal Investigator: Richard J. Servatius, PhD Syracuse VA Medical Center, Syracuse, NY

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03810781     History of Changes
Other Study ID Numbers: F2882-P
RX002882-01A1 ( Other Grant/Funding Number: Department of Veterans Affairs )
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Posturography
Spinal Cord Injury

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