Clinical trial NCT03810781: Postural Stability in Cervical Spinal Myelopathy
Official title: Study of Postural Stability in Subjects With Myelopathy Using a Portable Virtual Reality Balance Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spondylotic Myelopathy
Keywords: Posturography
Spinal Cord Injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Temple University
First posted: 2019-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US Veterans.

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.

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.

Eligibility 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

Primary outcomes:
measure: Virtual Environment TBI System (VETS) assessment of Static Posturography
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: Change in Posturography
timeFrame: Presurgery compared to 2 weeks, 6 weeks, and 6 months post-surgery. The Post-surgery endpoints are normally scheduled clinical follow ups.
Secondary outcomes:
measure: Nurick Scale
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: Neck Disability Index (NDI)
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: Short Form-36 version 2 (SF-36v2)
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: EC FIRM/EO FIRM ratio
timeFrame: PreSurgery
measure: EO FOAM/EO FIRM
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: EC FOAM/EO FOAM ratio
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: DYN FOAM/DYN FIRM ratio
timeFrame: PreSurgery compared to otherwise healthy veterans
measure: DYN FIRM/ EO FIRM ratio
timeFrame: PreSurgery compared to otherwise healthy veterans
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: Syracuse VA Medical Center, Syracuse, NY
name: Richard J. Servatius, PhD
role: PRINCIPAL_INVESTIGATOR
References: