Study of Postural Stability in Subjects With Myelopathy Using a Portable Virtual Reality Balance Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Virtual Environment TBI System (VETS) Assessment of Static Posturography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Virtual Environment TBI System (VETS) Assessment of Static Posturography
时间窗: Pre-Surgery 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. 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.
Change in Static Posturography (VETS)
时间窗: 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.
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.
次要结局
- 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)
- DYN FIRM/ EO FIRM Ratio(PreSurgery compared to otherwise healthy Veterans)
- EC FIRM/EO FIRM Ratio(PreSurgery)
- EO FOAM/EO FIRM(PreSurgery compared to otherwise healthy Veterans)
- EC FOAM/EO FOAM Ratio(PreSurgery compared to otherwise healthy Veterans)
- DYN FOAM/DYN FIRM Ratio(PostSurgery compared to otherwise healthy Veterans compared to otherwise healthy Veterans)