A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Average number of sessions completed
研究概览
简要总结
This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. The results will inform future dosing and efficacy studies.
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
- •New diagnosis stroke, new dysphagia, medically stable, adequate trunk strength for videofluoroscopy.
排除标准
- •Severe cognitive impairment, previous dysphagia, previous neurological condition, severe visual impairment
研究组 & 干预措施
Biofeedback group
Dysphagia therapy using surface EMG as biofeedback - 10 x 45 minute sessions of swallow strength and skill training using surface electromyography as biofeedback tool. This group will also receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education.
干预措施: Usual Care (Behavioral)
Control group
This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education
干预措施: Usual Care (Behavioral)
Biofeedback group
Dysphagia therapy using surface EMG as biofeedback - 10 x 45 minute sessions of swallow strength and skill training using surface electromyography as biofeedback tool. This group will also receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education.
干预措施: Dysphagia therapy using surface EMG as biofeedback (Behavioral)
结局指标
主要结局
Average number of sessions completed
时间窗: 2 weeks
Average number of sessions completed across participants.
Number of participants completing the treatment
时间窗: 2 weeks
Count of number of participants completing the treatment
Number of participants recruited
时间窗: 2 weeks
Count of number of participants can be recruited
次要结局
- Change in swallow physiology - timing(Pre and post 2 week intervention)
- Quality of life(Pre and post 2 week intervention and at 90 days)
- Change in Clinical outcomes - disability(Pre and post 2 week intervention and at 90 days.)
- Change in Swallow function - severity(Pre and post 3 week intervention intervention and at 90 days)
- Change in Swallow function - intake(Pre and post 3 week intervention intervention and at 90 days)
- Change in Swallow physiology - PAS(Pre and post 2 week intervention)
- Change in Clinical outcomes - stroke severity(Pre and post 2 week intervention)
- Change in Clinical outcomes - mortality(Pre and post 2 week intervention and at 90 days.)
- Change in Clinical outcomes - tube status(Pre and post 2 week intervention and at 90 days.)
- Change in Clinical outcomes - pneumonia(Pre and post 2 week intervention and at 90 days.)