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

NCT03145740 | Completed DMC

• 1 other identifier: H-2-2013-162
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• Severity of Dysphagia

  Baseline and three weeks

• Ability to eat and drink

  Baseline and three weeks

Study Arms (2)

Intensive F.O.T.T.®

EXPERIMENTAL

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.

Other: Intensive F.O.T.T.®

Unspecific stimulation of face and mouth

PLACEBO COMPARATOR

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.

Other: Unspecific Stimulation of face and mouth

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.

Intensive F.O.T.T.®

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

Unspecific stimulation of face and mouth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dysphagia caused by severe ABI

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Unfallkrankenhaus Berlin: collaborator

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Unit

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 9, 2017
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share