Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- SOT composite score
研究概览
简要总结
People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dizziness handicap inventory score at time of enrolment over 30
- •Unilateral vestibular weakness confirmed one or more of:
- •Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
- •VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
- •VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
- •Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
- •Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
- •Symptomatic
- •Long-standing/persistent symptoms greater than six months
排除标准
- •Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
- •Neurological deficit or proprioception deficit
- •Poor vision or blindness
- •Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal dehiscence (SDCS)
- •Active benign paroxysmal positional vertigo (BPPV)
- •Undergoing treatment which may affect balance or ability to stand
- •Cognitive impairment that prevents understanding and responding to instructions required to complete the study
- •Inability to provide informed consent
结局指标
主要结局
SOT composite score
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)
Dizziness Handicap Inventory
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)
次要结局
- LOS excursion(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- DHI component scores(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- ABC Score(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- LOS directional control(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- FES-I score(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- SOT condition scores(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- SOT vestibular contribution(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
研究者
Eytan A. David
MD, FRCSC, Clinical Instructor, Dept. of Surgery
University of British Columbia