Gaze and Postural Stability in People With MS: Characterizing Deficits and Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Dizziness Handicap Inventory
研究概览
简要总结
In order to provide information that will improve therapy, the goals of this project are to determine if persons with MS with complaints of dizziness and at risk for falls can improve their balance and vision stability as a result of a bout of specific treatment. This project seeks to do this by conducting an experiment where people with MS are randomly assigned to a group that practices activities known to help improve inner ear function or a group that practices activities known to improve endurance and strength but that should not change inner ear function. Such a comparison will allow us to gain understanding of how the inner ear system is affected in MS and how it responds to treatment.
详细描述
A variety of sources of evidence suggest altered vestibular function in people diagnosed with MS (PwMS). These sources of evidence include [a] subjective complaints of dizziness / vertigo, [b] altered subjective visual vertical, [c] altered vestibular evoked myogenic potentials, [d] altered performance on the vestibular dominant components of the sensory organization test, and [e] pilot reports of gaze stabilization deficits during vestibular ocular reflex (VOR) testing from the investigator's research group. These findings suggest vestibular deficits are present in PwMS. Epidemiological studies document cerebellar and brainstem involvement in 23% of PwMS at disease onset, increasing to 82% after longstanding illness. These vestibular deficits contribute to motion sensitivity, dizziness, imbalance, and falls. Regardless, dizziness and falls have a significant negative impact on quality of life. Multiple studies show that falls are a major disabling symptom in MS affecting approximately 75% of PwMS. The high incidence of falls in MS, is an important health concern due to its associations with injury-related morbidities, mortality and financial costs.
The vestibular pathways responsible for gaze and postural stability, as well as sensory integration reside in the brainstem, cerebellum and spinal cord. Demyelination of the pathways involving the vestibular nuclei complex within the brainstem and cerebellum adversely affect angular vestibulo-ocular reflex,vestibulo-spinal reflex function and sensory integration in PwMS. While evidence reports impairments in posturography and otolith mediated responses (vestibular evoked myogenic potentials), the responses mediated by the semicircular canal end organs and vestibular pathways have not been examined. Specifically, the learning and retention of gaze and postural stability as a result of task specific training program has not been studied in a well controlled clinical trial.
This proposal seeks to examine gaze and postural stability outcomes utilizing outcome measures that span the World Health Organization's International Classification of Function, Disability, and Health. Following completion of the baseline examination, PwMS will be randomized to one of two interventions: An Experimental Gaze and Postural Stability Training Group (GPS) or a Standard Care Aerobic Exercise Control Group (SCA). The two groups differ only by the presence of the GPS program in the experimental group. Both groups will participate in supervised exercise 3 times per week for 6 weeks followed by a post intervention testing period . After one month of no training, both groups will be brought back for a final follow-up examination to determine the retention of any training induced changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be assessed at baseline prior to randomization. Once baseline assessments are completed, participants will be randomized to one of 2 study groups. Interventions will occur at a different site than assessments to avoid unmasking. At the post test and follow-up assessment time points, participants will be instructed not to divulge their group assignment to their assessor (the same individual that assessed them at baseline).
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurologist-diagnosed, clinically definite MS
- •Expanded Disability Severity Scale (EDSS) score of less than 6.0
- •Current complaints of dizziness (DHI > 0)
- •At risk of falls (determined by > 2 falls in past year or Dynamic Gait Index <19 or Activity Specific Balance Confidence Scale <80
- •Ability to tolerate repetitive 5 min bouts of angular head motions.
排除标准
- •Central or Peripheral Nervous System disorders (other than MS)
- •Otologic, Cervical spine, or lower extremity injury in last 12 months
- •Exercise or alcohol use in last 48 hours
- •Currently taking vestibular suppressant medications
- •Peripheral Vestibular Pathology (BPPV, hypofunction, Meniere's disease
- •Internuclear Opthalmoplegia
- •MS exacerbation within last 8 weeks
- •Orthopedic, neurologic, or cognitive comorbidities that would limit participation in the study procedures
结局指标
主要结局
Dizziness Handicap Inventory
时间窗: At intervention completion (6 weeks)
Dizziness Handicap Inventory (DHI): The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability in PwMS.\[72-76\]. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap. Collected at intervention completion, adjusting for baseline (DHI values collected at baseline assessment, prior to intervention).
次要结局
- Dizziness Handicap Inventory Follow-up(1-month follow-up post intervention (10 weeks))
- Gaze Position Error(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Margin of stability(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Functional Gait Assessment(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Passive Angular Vestibulo-ocular Reflex Gain(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Activity Specific Balance Confidence Scale(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Mini-BEST test(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Dynamic Visual Acuity(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Compensatory Saccade Frequency(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Step Latency(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Compensatory Saccade Latency(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))
- Postural Sway(At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks))