Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Penetration-Aspiration scores
研究概览
简要总结
Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion and exclusion criteria will be consented into the clinical investigation. Patients who meet the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to either active (motor or sensory) or standard treatment (control group) arms.
Subjects included in this clinical investigation will be evaluated at screening, 1-week, 3-months and at 12-months post treatment.
The main aim of the study will be to assess the effect of VitalStim therapy on improving the safety of swallow according to the VFS, after the treatment and at 1-year follow up, on patients with chronic post-stroke OD.
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 (Outcomes Assessor)
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
- •Subject is over 18 years of age.
- •Subject is suspected of having oropharyngeal dysphagia.
- •Subject is able to comply with videofluoroscopy protocol.
- •Subject diagnosed with stroke.
- •Subject has no previous history of dysphagia.
- •Subjects who are able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained/ or a consultee has consented on the subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.
- •Subject is not currently participating in any other interventional clinical study.
- •Subject is able to comply with the protocol requirements
- •Subject scores 0 or 1 on question 1a of NIHSS
- •Randomization Inclusion Criteria:
- •Subject has confirmed dysphagia (PAS of 2 or more on VFS screening or pharyngeal residue).
排除标准
- •Subject stroke event occurred less than 3 months ago.
- •Subject is pregnant or a nursing mother.
- •Subject, in the opinion of the investigator, has advanced dementia
- •Subject fitted with a pacemaker or implantable cardiac defibrillator
- •Subject is dysphagic from conditions other than stroke
- •Subject has been diagnosed with a progressive neurological disorder, such as Parkinson's disease or Multiple Sclerosis.
- •Subject with active neoplasm or infection process.
结局指标
主要结局
Change in Penetration-Aspiration scores
时间窗: baseline and 1 year
次要结局
- Incidence of all adverse events(1 year)
- Time from randomisation to death(1 year)
- Change in pharyngeal residue prevalence(1 year)
- Frequency of chest infections(1 year)
- Change in EAT-10 scores(1 year)
研究者
Pere Clave
MD, PhD
Hospital de Mataró