Intensive Faciltiation of Swallowing in Patients With Severe Dysphagia After Acquired Brain Injury

Not Applicable

Completed

• Conditions: Deglutition Disorders
• Interventions: Other: Unspecific Stimulation of face and mouth; Other: Intensive F.O.T.T.®

• Registration Number: NCT03145740
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-04-10
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-05
• Last Update Submitted: 2017-05-05
• Study First Posted: 2017-05-09
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with dysphagia caused by severe ABI

Exclusion Criteria

• congenital brain damage, psychiatric diagnosis, history of head and neck cancer, agitated behaviour, need for tracheostomy tube

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unspecific stimulation of face and mouth	Unspecific Stimulation of face and mouth	The intervention in the control group was given twice a day, approximately 20 minutes per intervention, exclusive time to position the patient. Patients in the control group were before and after the intervention, positioned in a standardized way in side lying for 10 minutes to rest. The EMBI measured the spontaneous swallowing frequency and -quality during both, the resting period and the intervention. The intervention included unspecific stimulation of the hands and the face, without therapeutic interventions directed towards facilitation of swallowing.
Intensive F.O.T.T.®	Intensive F.O.T.T.®	Intensive F.O.T.T.® intervention was given twice a day, approximately 20 minutes per intervention, exclusive time to position the patient. Before and after the intervention, the patient was positioned in a standardized way in side lying for 10 minutes to rest. Here, the Electromyographic Bioimpedance Measuring device (EMBI) measured the spontaneous swallowing frequency and -quality during both, the resting period and the intervention. In the intervention itself, the patient was facilitated with specific handling and interventions to swallow, according to F.O.T.T.®. The faciltation was embedded into a meaningful context for the patient, e.g. tooth brushing or eating small amounts of apple sauce, if safe.

Primary Outcome Measures

Name	Time	Method
Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)	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.	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Severity of Dysphagia	Baseline and three weeks	Scored on the Penetration Aspiration Scale (PAS) during Fiberoptic Endoscopic Evaluation of Swallowing
Ability to eat and drink	Baseline and three weeks	Scored on the Functional Oral Intake Scale (FOIS)