Skip to main content
OpenTrials
Completed

NCT Number: NCT03145740

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 mouth

Other

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

Primary outcomes

  1. Change in swallowing frequency of saliva.

    Time frame: 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.

  2. Change in swallowing quality of saliva (speed of laryngeal elevation)

    Time frame: 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.

  3. Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)

    Time frame: 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.

  4. Change in swallowing quality of saliva (time of pharyngeal closure during swallowing)

    Time frame: 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.

  5. Change in swallowing quality of saliva (pumping jaw movements before swallowing)

    Time frame: 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.

Secondary outcomes

  1. Severity of Dysphagia

    Time frame: Baseline and three weeks

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

  2. Ability to eat and drink

    Time frame: Baseline and three weeks

    Scored on the Functional Oral Intake Scale (FOIS)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Unfallkrankenhaus Berlin

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 9, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.