The Effect of Intensive Facial Oral Tract Therapy (F.O.T.T.®) on Swallowing Function in Patients After Acquired Brain Injury (ABI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)
研究概览
简要总结
This study is a randomized controlled trial (RCT). Patients after severe acquired brain injury (ABI) were randomised in addition to the individual daily rehabilitation program to intensive Facial Oral Tract Therapy (F.O.T.T.®) (intervention group) or unspecific treatment: washing face, brushing teeth, without facilitating swallowing (control group).
The duration of the intervention period was 15 working days (3 weeks). The intervention in both groups was twice a day.
详细描述
The F.O.T.T.® approach uses structured tactile input and facilitation techniques in meaningful everyday life context, aiming for improving function in the face and oral tract that is as normal as possible. The goal is maximum participation in daily life. The treatment encourages learning of helpful functional movements or patterns of movement for safe swallowing, protection of airway, oral hygiene, eating, drinking, breathing, voice and articulation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patient´s primary physician in the clinic, the primary occupational therapist, physiotherapist and the nurses were kept blinded for the whole period of the intervention.
The patient´s relatives did know into what group the patient was randomized. The patient himself did not know. The occupational therapists associated to the project were not blinded.
The otolaryngologist, who scored the video recorded FEES examinations was blinded. The colleagues from Germany, who analyse data are blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dysphagia caused by severe ABI
排除标准
- •congenital brain damage, psychiatric diagnosis, history of head and neck cancer, agitated behaviour, need for tracheostomy tube
结局指标
主要结局
Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)
时间窗: Change from baseline quality swallowing at three weeks.
EMBI is a measure device, measuring the range of movement of laryngeal elevation during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.
Change in swallowing frequency of saliva.
时间窗: Change from baseline frequency of swallowing at three weeks.
EMBI is a measure device, measuring the number of spontaneous and facilitated swallows by electromyographic and bioimpedance signals.
Change in swallowing quality of saliva (time of pharyngeal closure during swallowing)
时间窗: Change from baseline quality of swallowing at three weeks.
EMBI is a measure device, measuring the time of pharyngeal closure during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.
Change in swallowing quality of saliva (pumping jaw movements before swallowing)
时间窗: Change from baseline quality of swallowing at three weeks.
EMBI is a measure device, measuring the pumping jaw movements during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.
Change in swallowing quality of saliva (speed of laryngeal elevation)
时间窗: Change from baseline quality of swallowing at three weeks.
EMBI is a measure device, measuring the speed of laryngeal elevation during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.
次要结局
- Severity of Dysphagia(Baseline and three weeks)
- Ability to eat and drink(Baseline and three weeks)
研究者
Ingrid Poulsen
Head of Research Unit
Rigshospitalet, Denmark