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Cervical Spondylotic MyelopathyNCT03810781

Postural Stability in Cervical Spinal Myelopathy

An observational study of Cervical Spondylotic Myelopathy, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cervical Spondylotic Myelopathy
How many people
8 participants
Where
1 siteUnited States
Study dates
7 Feb 2019to 1 Sep 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: US Veterans.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Syracuse VA Medical Center, Syracuse, NY

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Study of Postural Stability in Subjects With Myelopathy Using a Portable Virtual Reality Balance Protocol

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.

Read the detailed description

COVID-19 administrative hold

Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from rigors of military service. Diagnosis of CSM involves a set of clinical findings and is confirmed by imaging the spine.

Gait impairment and disturbances of stance control are hallmarks of CSM and are a consequence of abnormalities in proprioception due to dorsal column tract damage of the spine. Currently, gait and balance deficits rely on clinical level assessments and judgement for detection. An objective measure of posturography has the benefit of: a) quantifying balance-related disability in CSM, b) facilitating structure-functional assessments in CSM, and c) quantifying the degree surgical interventions affect posturography and recovery of function in CSM.

Objective and sensitive means for assessing balance and posturography exist, but are not routinely incorporated in diagnosis or functional tracking of progress after interventions such as surgery. A barrier may be accessibility of posturography and ease of assessments. The Virtual Environment TBI Screen (VETS) was devised using Army Rapid Innovation Development funding to objectively assess balance and posturography in a cost effective, but sensitive manner. VETS involves virtual environments and computerized posturography and is proving to be a sensitive system facilitating diagnosis, treatment, and mitigation of balance dysfunction associated with mTBI.

The working hypothesis is VETS testing will enhance clinical judgements regarding CSM. The SPiRE is designed to provide data critical to a more extensive program of research incorporating posturography into treatment and rehabilitation of CSM.

First, a limited comparative study of standing balance will be conducted of 20 Veterans being evaluated for cervical spine surgery to treat CSM and 20 otherwise healthy Veterans. Second, posturography of the Veterans undergoing surgery to treat CSM will be tracked during their scheduled follow up visits to determine the degree VETS scores are affected by surgery and to track recovery from CSM.

Patients in the CSM group will be selected based on clinical criteria. Veterans in the control group will be recruited from the Syracuse Veterans Affairs Medical Center (SVAMC) and surrounding community.

For VETS testing, the Veteran will stand directly on a firm surface or foam pad placed on top of a Wii Balance Board (WBB). There are six conditions manipulating surface (firm or foam surface) and visual input (eyes open viewing a static scene, eyes closed, and eyes open viewing a dynamic visual scene). The primary measure is the center of pressure (COP) sway area. These 6 conditions allow for an assessment of generalized vs specific deficits in COP sway area considering proprioception, dependence of visual input and visuo-proprioceptive integration.

AIM 1A: Determine whether and to what degree balance is altered in CSM. The degree of COP sway will be compared between CSM and controls in the six conditions comprising VETS testing.

AIM 1B: Determine whether VETS enhances sensitivity and selectivity in the diagnosis of CSM. Composite measures of balance will be related to clinical assessment tools and their relationship with MRI.

AIM 2: Evaluate the VETS scores after surgery to treat CSM. The degree of COP sway area under the 6 conditions will be compared before surgery, 2 weeks, 6 weeks and 6 months after surgery (corresponding with post-operative clinical assessments).

The ultimate goal is to validate and incorporate objective balance testing into routine assessment for CSM to aid in disambiguating CSM, to improve functional assessments of recovery, and to aid in evaluations of different treatment and rehabilitation strategies in CSM for the Veteran population.

Keywords
Posturography, Spinal Cord Injury
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03810781
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virtual Environment TBI System (VETS) Assessment of Static Posturography

    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. a) Comparison of CSM vs. Control and within-subject visual (EO,EC, and DYN) and surface conditions (FIRM and FOAM). b) Comparison of balance and posture at Pre-surgery for CSM group to age and gender matched non-CSM controls. Only pre-surgery data in CSM group was collected due to COVID-19.

    Measured: Pre-Surgery compared to otherwise healthy Veterans

  2. Change in Static Posturography (VETS)

    The Pre-surgery CSM group recruited for VETS (Static Posturography) measurement will also serve as the sample for the change in VETS measurement as a change in centimeters (cm). This is a longitudinal assessment of balance following surgical intervention for CSM.

    Measured: Pre-surgery compared to 2 weeks, 6 weeks, and 6 months post-surgery VETS factors. The Post-surgery endpoints are normally scheduled clinical follow ups.

Secondary outcomes (8)
  1. Nurick Scale

    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. Classification Scheme:

    • Grade 0: signs or symptoms of root involvement but without evidence of spinal cord disease
    • Grade 1: signs of spinal cord disease but no difficulty in walking.
    • Grade 2: slight difficulty in walking which does not prevent full-time employment
    • Grade 3: difficulty in walking which prevented full time employment or the ability to do all housework, but which was not so severe as to require someone else's help to walk
    • Grade 4: able to walk only with someone else's help or with the aid of a frame.
    • Grade 5 : chairbound or bedridden.

    Measured: PreSurgery compared to otherwise healthy Veterans

  2. Neck Disability Index (NDI)

    NDI is related to VETS posturography to determine sensitivity of standing posture to degree of disability. 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. Score: /50 Transform to percentage score x 100 = %points. Scoring: Example:16 (total scored)50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored)45 (total possible score) x 100 = 35.5% Minimum Detectable Change (90% confidence): 5 points or 10 %points

    Measured: PreSurgery compared to otherwise healthy Veterans

  3. Short Form-36 Version 2 (SF-36v2)

    The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). The SF-36 offers a choice of recall format at a standard (4 week) or acute (1 week) time frame. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.

    Measured: PreSurgery compared to otherwise healthy Veterans

  4. EC FIRM/EO FIRM Ratio

    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. The Romberg test used in posturography compares postural sway in eyes open (EO) and eyes closed (EC) conditions. The Romberg ratio was calculated in the traditional manner, i.e. EC/EO. The ensuing Romberg ratio (EC/EO) is used to assess visual dependency in postural stability. Higher Romberg ratios reflect greater instability with closed eyes, ( a greater amount of postural sway during eyes closed) whereas a ratio < 1 indicates higher stability in the EC versus EO condition.

    Measured: PreSurgery

  5. EO FOAM/EO FIRM

    From the VETS, a ratio of COP sway will be used to determine the degree static posture is affected by reduced proprioception.

    Measured: PreSurgery compared to otherwise healthy Veterans

  6. EC FOAM/EO FOAM Ratio

    From the VETS, a ratio of COP sway will be used to determine the degree of loss of visual information. Loss of visual information compounds reduced proprioceptive ability in static balance.

    Measured: PreSurgery compared to otherwise healthy Veterans

  7. DYN FOAM/DYN FIRM Ratio

    From the VETS, a ratio of COP sway will be used to determine how roll vection is induced by loss of proprioception.

    Measured: PostSurgery compared to otherwise healthy Veterans compared to otherwise healthy Veterans

  8. DYN FIRM/ EO FIRM Ratio

    From the VETS, a ration of COP sway to determine the degree roll vection is induced.

    Measured: PreSurgery compared to otherwise healthy Veterans

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start7 Feb 2019
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03810781
Sponsor's protocol ID
F2882-P
Other IDs
RX002882-01A1
Status last verified
Nov 2025
First submitted
16 Jan 2019
Last updated
15 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Spondylotic Myelopathy, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virtual Environment TBI System (VETS) Assessment of Static Posturography (time frame: Pre-Surgery compared to otherwise healthy Veterans). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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