N/A
N=8
Postural Stability in Cervical Spinal Myelopathy
Cervical Spondylotic Myelopathy
Bottom Line
View on ClinicalTrials.gov: NCT03810781 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Virtual Environment TBI System (VETS) Assessment of Static Posturography — 11; 13.0; 48.4; 19.1 Square Centimeters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Virtual Environment TBI System (VETS) Assessment of Static Posturography |
11; 13.0; 48.4; 19.1; 44; 70.7 | — |
| PRIMARY Change in Static Posturography (VETS) |
11; 13; 48.4; 19.1; 44; 70.7 | — |
| SECONDARY Nurick Scale |
2 | — |
| SECONDARY Neck Disability Index (NDI) |
59.5 | — |
| SECONDARY Short Form-36 Version 2 (SF-36v2) |
44.1 | — |
| SECONDARY EC FIRM/EO FIRM Ratio |
1.56 | — |
| SECONDARY EO FOAM/EO FIRM |
2.92 | — |
| SECONDARY EC FOAM/EO FOAM Ratio |
8.43 | — |
| SECONDARY DYN FOAM/DYN FIRM Ratio |
8.7 | — |
| SECONDARY DYN FIRM/ EO FIRM Ratio |
6.49 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03810781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.