Intensive Faciltiation of Swallowing in Patients With Severe Dysphagia After Acquired Brain Injury
NCT ID: NCT03145740
Last Updated: 2017-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2014-04-30
2016-12-31
Brief Summary
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The duration of the intervention period was 15 working days (3 weeks). The intervention in both groups was twice a day.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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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.
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 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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Unfallkrankenhaus Berlin
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Ingrid Poulsen
Head of Research Unit
Other Identifiers
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H-2-2013-162
Identifier Type: -
Identifier Source: org_study_id
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