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

Primary Purpose

Deglutition Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive F.O.T.T.®
Unspecific Stimulation of face and mouth
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deglutition Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intensive F.O.T.T.®

    Unspecific stimulation of face and mouth

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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 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 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 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 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.

    Secondary Outcome Measures

    Severity of Dysphagia
    Scored on the Penetration Aspiration Scale (PAS) during Fiberoptic Endoscopic Evaluation of Swallowing
    Ability to eat and drink
    Scored on the Functional Oral Intake Scale (FOIS)

    Full Information

    First Posted
    April 10, 2017
    Last Updated
    May 5, 2017
    Sponsor
    Rigshospitalet, Denmark
    Collaborators
    Unfallkrankenhaus Berlin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03145740
    Brief Title
    Intensive Faciltiation of Swallowing in Patients With Severe Dysphagia After Acquired Brain Injury
    Official Title
    The Effect of Intensive Facial Oral Tract Therapy (F.O.T.T.®) on Swallowing Function in Patients After Acquired Brain Injury (ABI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark
    Collaborators
    Unfallkrankenhaus Berlin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deglutition Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensive F.O.T.T.®
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Unspecific stimulation of face and mouth
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Intensive F.O.T.T.®
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Unspecific Stimulation of face and mouth
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in swallowing frequency of saliva.
    Description
    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.
    Title
    Change in swallowing quality of saliva (speed of laryngeal elevation)
    Description
    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.
    Title
    Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)
    Description
    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.
    Title
    Change in swallowing quality of saliva (time of pharyngeal closure during swallowing)
    Description
    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.
    Title
    Change in swallowing quality of saliva (pumping jaw movements before swallowing)
    Description
    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 Outcome Measure Information:
    Title
    Severity of Dysphagia
    Description
    Scored on the Penetration Aspiration Scale (PAS) during Fiberoptic Endoscopic Evaluation of Swallowing
    Time Frame
    Baseline and three weeks
    Title
    Ability to eat and drink
    Description
    Scored on the Functional Oral Intake Scale (FOIS)
    Time Frame
    Baseline and three weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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