Postural Stability in Cervical Spinal Myelopathy
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|ClinicalTrials.gov Identifier: NCT03810781|
Recruitment Status : Active, not recruiting
First Posted : January 22, 2019
Last Update Posted : October 22, 2020
|Condition or disease|
|Cervical Spondylotic Myelopathy|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Study of Postural Stability in Subjects With Myelopathy Using a Portable Virtual Reality Balance Protocol|
|Actual Study Start Date :||February 7, 2019|
|Actual Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2021|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New York|
|Syracuse VA Medical Center, Syracuse, NY|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Richard J. Servatius, PhD||Syracuse VA Medical Center, Syracuse, NY|