Trial Outcomes & Findings for Postural Stability in Cervical Spinal Myelopathy (NCT NCT03810781)
NCT ID: NCT03810781
Last Updated: 2025-12-15
Results Overview
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.
COMPLETED
8 participants
Pre-Surgery compared to otherwise healthy Veterans
2025-12-15
Participant Flow
Recruitment was significantly hampered by COVID-19 and research shut-downs. Myelopathy surgeries were significantly limited because of COVID as well. Participants were recruited from the pool of eligible individuals undergoing surgery for myelopathy in the Syracuse VA. Recruitment occurred between 2/7/19 and 7/26/22
This did not occur
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
COVID shut down
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cervical Spondylotic Myelopathy (CSM) Group
n=6 Participants
Veterans with CSM. CSM is 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.
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|---|---|
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Age, Continuous
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63 years
STANDARD_DEVIATION 3.75 • n=6 Participants
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Sex: Female, Male
Female
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0 Participants
n=6 Participants
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Sex: Female, Male
Male
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6 Participants
n=6 Participants
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Region of Enrollment
United States
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6 Participants
n=6 Participants
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PRIMARY outcome
Timeframe: Pre-Surgery compared to otherwise healthy VeteransPopulation: COVID facility entry restrictions at the Syracuse VA Medical Center prevented the recruitment of participants who were not already coming to the VA for medical appointments.
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.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
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Healthy Controls
Control participants with no spinal problems
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|---|---|---|
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Virtual Environment TBI System (VETS) Assessment of Static Posturography
EO Firm
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11 Square Centimeters
Standard Deviation 27.1
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—
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Virtual Environment TBI System (VETS) Assessment of Static Posturography
EC Firm
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13.0 Square Centimeters
Standard Deviation 15.4
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—
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Virtual Environment TBI System (VETS) Assessment of Static Posturography
DYN Firm
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48.4 Square Centimeters
Standard Deviation 51.1
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—
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Virtual Environment TBI System (VETS) Assessment of Static Posturography
EO Foam
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19.1 Square Centimeters
Standard Deviation 20.3
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—
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Virtual Environment TBI System (VETS) Assessment of Static Posturography
EC Foam
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44 Square Centimeters
Standard Deviation 32.7
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—
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Virtual Environment TBI System (VETS) Assessment of Static Posturography
DYN Foam
|
70.7 Square Centimeters
Standard Deviation 47.7
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—
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PRIMARY outcome
Timeframe: 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.Population: Subjects were gradually lost to follow-up, leading to a decline in the number of participants analyzed in later sessions.
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.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
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|---|---|---|
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Change in Static Posturography (VETS)
EC Foam 6Weeks
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37.6 CM
Standard Deviation 31
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—
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Change in Static Posturography (VETS)
DYN Foam 6Weeks
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88.5 CM
Standard Deviation 68.7
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—
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Change in Static Posturography (VETS)
DYN Firm 6Months
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24.7 CM
Standard Deviation 33.8
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—
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Change in Static Posturography (VETS)
EO Foam 6Months
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13.5 CM
Standard Deviation 6.1
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—
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Change in Static Posturography (VETS)
EC Foam 6Months
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41.4 CM
Standard Deviation 19.1
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—
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Change in Static Posturography (VETS)
DYN Foam 6Months
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62.9 CM
Standard Deviation 38.1
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—
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Change in Static Posturography (VETS)
DYN Foam 2Weeks
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63.5 CM
Standard Deviation 39.6
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—
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Change in Static Posturography (VETS)
EO Firm 6Weeks
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7.2 CM
Standard Deviation 9.8
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—
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Change in Static Posturography (VETS)
EC Firm 6Weeks
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15.6 CM
Standard Deviation 22.1
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—
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Change in Static Posturography (VETS)
DYN Firm 6Weeks
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15.4 CM
Standard Deviation 15.1
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—
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Change in Static Posturography (VETS)
EO Foam 6Weeks
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12.2 CM
Standard Deviation 7.5
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—
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Change in Static Posturography (VETS)
EO Firm 6Months
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5 CM
Standard Deviation 5.4
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—
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Change in Static Posturography (VETS)
EC Firm 6Months
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12 CM
Standard Deviation 15.1
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—
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Change in Static Posturography (VETS)
EC Foam 2Weeks
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44.3 CM
Standard Deviation 28.7
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—
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Change in Static Posturography (VETS)
EO Firm PreOp
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11 CM
Standard Deviation 27.1
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—
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Change in Static Posturography (VETS)
EC Firm PreOp
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13 CM
Standard Deviation 15.4
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—
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Change in Static Posturography (VETS)
DYN Firm PreOp
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48.4 CM
Standard Deviation 51.1
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—
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Change in Static Posturography (VETS)
EO Foam PreOp
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19.1 CM
Standard Deviation 20.3
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—
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Change in Static Posturography (VETS)
EC Foam PreOp
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44 CM
Standard Deviation 32.7
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—
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Change in Static Posturography (VETS)
DYN Foam PreOp
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70.7 CM
Standard Deviation 47.7
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—
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Change in Static Posturography (VETS)
EO Firm 2Weeks
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5.6 CM
Standard Deviation 4.3
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—
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Change in Static Posturography (VETS)
EC Firm 2Weeks
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9.4 CM
Standard Deviation 8.5
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—
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Change in Static Posturography (VETS)
DYN Firm 2Weeks
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11.2 CM
Standard Deviation 7
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—
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Change in Static Posturography (VETS)
EO Foam 2Weeks
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9.8 CM
Standard Deviation 7
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—
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SECONDARY outcome
Timeframe: PreSurgery compared to otherwise healthy VeteransPopulation: The investigators did not recruit any controls as we could not run participants who did not already have a clinical appointment, due to COVID restrictions
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.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
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|---|---|---|
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Nurick Scale
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2 Units on a scale
Standard Deviation .89
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—
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SECONDARY outcome
Timeframe: PreSurgery compared to otherwise healthy VeteransPopulation: The investigators did not recruit any controls as we could not run participants who did not already have a clinical appointment, due to COVID restrictions
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
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
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|---|---|---|
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Neck Disability Index (NDI)
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59.5 Units on a scale
Standard Deviation 17.5
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—
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SECONDARY outcome
Timeframe: PreSurgery compared to otherwise healthy VeteransPopulation: Healthy controls could not be recruited because of COVID restrictions
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.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
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|---|---|---|
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Short Form-36 Version 2 (SF-36v2)
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44.1 Units on a scale
Standard Deviation 21.1
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—
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SECONDARY outcome
Timeframe: PreSurgeryFrom 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.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
|
|---|---|---|
|
EC FIRM/EO FIRM Ratio
|
1.56 COP sway ratio
Standard Deviation 1.03
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—
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SECONDARY outcome
Timeframe: PreSurgery compared to otherwise healthy VeteransPopulation: The investigators could not recruit controls due to COVID restrictions
From the VETS, a ratio of COP sway will be used to determine the degree static posture is affected by reduced proprioception.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
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|---|---|---|
|
EO FOAM/EO FIRM
|
2.92 COP sway ratio
Standard Deviation 3.17
|
—
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SECONDARY outcome
Timeframe: PreSurgery compared to otherwise healthy VeteransPopulation: Could not recruit controls due to COVID restrictions
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.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
|
|---|---|---|
|
EC FOAM/EO FOAM Ratio
|
8.43 COP sway ratio
Standard Deviation 11.8
|
—
|
SECONDARY outcome
Timeframe: PostSurgery compared to otherwise healthy Veterans compared to otherwise healthy VeteransPopulation: Could not recruit controls due to COVID restrictions. Only 4 CSM participants were analyzed compared to the 6 anticipated due to data capture failure in 2 participants during DYN Foam condition and facility entrance policies restricted patient flow for the remainder of the study. Three of them had incomplete trial sessions, but this does not affect overall calculation as this was taken into consideration.
From the VETS, a ratio of COP sway will be used to determine how roll vection is induced by loss of proprioception.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=4 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
|
|---|---|---|
|
DYN FOAM/DYN FIRM Ratio
|
8.7 COP Sway ratio
Standard Deviation 13.76
|
—
|
SECONDARY outcome
Timeframe: PreSurgery compared to otherwise healthy VeteransPopulation: Could not recruit controls due to COVID restrictions
From the VETS, a ration of COP sway to determine the degree roll vection is induced.
Outcome measures
| Measure |
Pre-surgical Group: Cervical Spondylotic Myelopathy (CSM)
n=6 Participants
Pre-surgical group: 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.
|
Healthy Controls
Control participants with no spinal problems
|
|---|---|---|
|
DYN FIRM/ EO FIRM Ratio
|
6.49 COP Sway ratio
Standard Deviation 6.62
|
—
|
Adverse Events
Cervical Spondylotic Myelopathy (CSM)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place