Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)
研究概览
简要总结
People that have difficulty with balance, such as those with damage to their inner ear, have a higher risk of falling, which may lead to anxiety and reduced quality of life. Some individuals that have lost part of their sense of balance can learn to compensate using information from their vision, their sense of where their limbs are in space, and from other balance organs that are still intact. Our study aims to determine if virtual reality used together with information from footplate sensors can be used to train people with balance problems to compensate for their inner ear deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult Age 18-80
- •Unilateral vestibular weakness confirmed one or more of:
- •Videonystagmography
- •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 one year
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 deshicsence (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
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway Calculated as a composite of the 6 individual conditions of the SOT: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)
时间窗: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284. LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)
次要结局
- Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)(Through study completion, 12 rehabilitation sessions, an average of 7 weeks)
- Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)(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