NCT05056324已完成不适用
Internet-based Vestibular Rehabilitation Versus Standard Care After Acute Onset Vertigo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 10
- 主要终点
- The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference
研究概览
简要总结
Acute onset vertigo is common and entails much suffering with persisting symptoms at 3 months after onset in up to half of those afflicted. Vestibular rehabilitation to aid recovery is not readily available. The purpose of this study is to investigate the effects on vertigo symptoms of a 6-week online vestibular rehabilitation tool compared with standard care (written instructions leaflet) after acute onset vertigo.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old; and
- •The subject has given written consent to participate in the study; and
- •New acute onset dizziness or vertigo since ≥24 hours with pathological spontaneous or gaze-evoked nystagmus (i.e. an acute vestibular syndrome, AVS). The nystagmus as described above must be present at investigation between 24 hours and 7 days from onset, spontaneously, gaze-evoked or head-shake evoked and documented; and
- •Screening and inclusion within 7 days of onset of continuous symptoms; and
- •Symptomatic at inclusion
排除标准
- •Pre-existing vestibular disease or neurological disease anticipated to affect the ability to participate in the study or the effect of the intervention. N.B: Recurring AVS with no set diagnosis before inclusion is accepted, as is past transient neurological diseases such as TIA or migraine; or
- •Inability to use the online rehabilitation tool, e.g. due to not having access to a computer, tablet or smartphone, not having access to the internet or lacking in experience with such tools; or
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; or
- •Medical and/or physical contraindications to making the required head movements (e.g. vertebral dissection) or otherwise participating in the training and testing exercises or data collection; or
- •Medication or other substance intake which can affect the ability to participate in the study or the reliability of the measurement methods. These medications include regular use of: Anticonvulsants, antiemetics/motion sickness medications, benzodiazepines, neuroleptics. Transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.
结局指标
主要结局
The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference
时间窗: 6 weeks after vertigo onset
VSS-SF uses a five-point Likert scale: 0 (never), 1 (a few times), 2 (several times), 3 (quite often \[every week\]), and 4 (very often \[most days\]). The score ranges from 0 to 60. A higher score indicates worse symptoms.
次要结局
- The between groups changes in video head impulse test (vHIT, site-dependent)(6 weeks and 3 months after vertigo onset)
- The between groups mean Dizziness Handicap Inventory (DHI) score(6 weeks and 3 months after vertigo onset)
- The between groups changes in timed 25-foot walk test (T25-FW)); body sway during standing and walking; and the mobility(From baseline to 6 weeks and 3 months)
- The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades(From baseline to 6 weeks and 3 months)
- The between groups mean vertigo symptom scale short form (VSS-SF) score(12 months after vertigo onset)
- The between group pedometer-derived mean weekly number of steps walked since last visit(3 months after vertigo onset)
- The between groups mean number of weekly training sessions(6 weeks after vertigo onset)
- Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave)(12 months)
- The reliability of the Swedish VSS-SF translation(Six weeks after symptom onset)
- The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests(6 weeks and 3 months after vertigo onset)
- The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)(Three months after symptom onset)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Online treatment for older dizzy patients in general practiceNL-OMON22573VU University Medical Center/EMGO+300
Unknown
不适用
Virtual Reality-based RehabilitationPatients With Unilateral Peripheral Vestibular DeficitsNCT04280302Universitat Pompeu Fabra20
已完成
不适用
Vestibular Rehabilitation in Patients With Vestibular MigraineVestibular DisorderMigraine VariantVestibular MigraineNCT03417596Ege University77
已完成
不适用
Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With VertigoVertigoNCT05392595Riphah International University26
已完成
不适用
Vestibular Rehabilitation and Severe Traumatic Brain InjurySevere Traumatic Brain InjuryGait Disorders, NeurologicNCT04415580I.R.C.C.S. Fondazione Santa Lucia30