Postural Stability in Cervical Spinal Myelopathy

NCT03810781 | Completed Results

• 2 other identifiers: F2882-PRX002882-01A1
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylotic Myelopathy

Keywords

Posturography; Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• 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.

  Pre-Surgery compared to otherwise healthy Veterans

• 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.

  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)

• Nurick Scale

  PreSurgery compared to otherwise healthy Veterans

• Neck Disability Index (NDI)

  PreSurgery compared to otherwise healthy Veterans

• Short Form-36 Version 2 (SF-36v2)

  PreSurgery compared to otherwise healthy Veterans

• EC FIRM/EO FIRM Ratio

  PreSurgery

• EO FOAM/EO FIRM

  PreSurgery compared to otherwise healthy Veterans

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

US Veterans.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Temple University: collaborator

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

COVID significantly disrupted our ability to complete the study. Scheduling for CSM surgery was drastically impacted by COVID and never returned to Pre-COVID format. Some subjects recruited before COVID could not be followed up due to a ban on research. We were also unable to recruit controls because our VA only permitted research appointments for individuals who were already coming to the VA for a medical appointment (e.g. surgical follow-up).

Results Point of Contact

• Title: Dr. Richard Servatius
• Organization: Syracuse VA Medical Center

richard.servatius@va.gov

315-744-3370

Study Officials

• Richard J. Servatius, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Study Start: February 7, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)