New Rehabilitation Protocol for Patients With Persistent Postural Perceptual Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Changes of Dizziness Handicap Inventory (DHI) score
研究概览
简要总结
The investigators will test a new rehabilitation protocol on patients with persistent postural perceptual dizziness (PPPD). The investigators hypothesize that patients with PPPD, in the absence of vestibular deficits, do not benefit from standard vestibular rehabilitation but instead need a rehabilitation that acts on visual and postural stability, through training of saccadic movements in dynamic contexts of cognitive-motor dual-task and rehabilitation of postural stability.
详细描述
Persistent postural-perceptual dizziness (PPPD) is a chronic functional vestibular disorder that manifests as a sensation of non-vertiginous dizziness and instability.
The most common triggers of PPPD are peripheral vestibular conditions such as vestibular neuritis (VN) and benign paroxysmal positional vertigo (BPPV), although vestibular migraine, central vestibular disorders and non-vestibular conditions such as panic attacks, minor injuries traumatic brain injury and also orthostatic intolerance have been reported as precipitants of PPPD. PPPD persists after the triggering events have resolved.
The diagnostic criteria for PPPD were established by the Barany Society. Once the negativity of the routine vestibular tests has been ascertained, the diagnosis is based on additional criteria such as the persistence of the symptom of dizziness for most of the time for at least 3 months, the worsening of the symptoms when standing, during active movement or passive, during exposure to moving visual stimulation or to visual stimuli with complex textures.
Existing treatments (e.g., selective serotonin reuptake inhibitors, vestibular habituation) are only partially successful in PPPD.
Methods. Experimental design. Single-blind randomized controlled trial. 40 individuals affected by PPPD will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted
排除标准
- •Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.
结局指标
主要结局
Changes of Dizziness Handicap Inventory (DHI) score
时间窗: pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3)
DHI.Questionnaire on the severity of dizziness (Dizziness Handicap Inventory, DHI). Scores range from 0 to 50; higher scores mean a worse outcome.
次要结局
- Changes of locomotion parameter linear acceleration measured through wearable inertial sensors(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
- Changes of locomotion parameter angular velocities measured through wearable inertial sensors(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
- Changes in postural oscillations(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
- Changes in visual dependence through rod and the disc test(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
研究者
Marco Tramontano
Head of Rehabilitation Services
I.R.C.C.S. Fondazione Santa Lucia