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

Rigshospitalet, Denmark10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Deglutition Disorders

Interventions

Intensive F.O.T.T.®OTHER

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 mouthOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in swallowing frequency of saliva.

EMBI is a measure device, measuring the number of spontaneous and facilitated swallows by electromyographic and bioimpedance signals.

Time frame: Change from baseline frequency of swallowing at three weeks.

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.

Time frame: Change from baseline quality of swallowing at three weeks.

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.

Time frame: Change from baseline quality swallowing at three weeks.

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.

Time frame: Change from baseline quality of swallowing at three weeks.

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.

Time frame: Change from baseline quality of swallowing at three weeks.

Secondary Outcomes

Severity of Dysphagia

Scored on the Penetration Aspiration Scale (PAS) during Fiberoptic Endoscopic Evaluation of Swallowing

Data from ClinicalTrials.gov

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