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

Deglutition Disorders Clinical Trial

Official title:

The Effect of Intensive Facial Oral Tract Therapy (F.O.T.T.®) on Swallowing Function in Patients After Acquired Brain Injury (ABI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145740
• Other study ID #: H-2-2013-162
• Status: Completed
• Phase: N/A
• First received: April 10, 2017
• Last updated: May 5, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Deglutition Disorders

Intervention

Other:
• Intensive F.O.T.T.®
Therapeutic F.O.T.T.® intervention provided by Occupational Therapists (OTs). The intervention consists of positioning the patient, and giving sensory input to the hands and face in order to stimulate and facilitate swallowing of saliva or small amounts of food and drink, if considered safe.
• Unspecific Stimulation of face and mouth
The intervention consists of positioning the patient and either washing his face, the hands, or brushing teeth, apply lipbalm, with no specific stimulation or facilitation of swallowing

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Unfallkrankenhaus Berlin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in swallowing frequency of saliva.	EMBI is a measure device, measuring the number of spontaneous and facilitated swallows by electromyographic and bioimpedance signals.	Change from baseline frequency of swallowing at three weeks.
Primary	Change in swallowing quality of saliva (speed of laryngeal elevation)	EMBI is a measure device, measuring the speed of laryngeal elevation during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.	Change from baseline quality of swallowing at three weeks.
Primary	Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)	EMBI is a measure device, measuring the range of movement of laryngeal elevation during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.	Change from baseline quality swallowing at three weeks.
Primary	Change in swallowing quality of saliva (time of pharyngeal closure during swallowing)	EMBI is a measure device, measuring the time of pharyngeal closure during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.	Change from baseline quality of swallowing at three weeks.
Primary	Change in swallowing quality of saliva (pumping jaw movements before swallowing)	EMBI is a measure device, measuring the pumping jaw movements during spontaneous and facilitated swallows by electromyographic and bioimpedance signals.	Change from baseline quality of swallowing at three weeks.
Secondary	Severity of Dysphagia	Scored on the Penetration Aspiration Scale (PAS) during Fiberoptic Endoscopic Evaluation of Swallowing	Baseline and three weeks
Secondary	Ability to eat and drink	Scored on the Functional Oral Intake Scale (FOIS)	Baseline and three weeks