Deglutition Disorders
Conditions
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.
Interventions
OTHERIntensive 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.
OTHERUnspecific 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
Sponsors
Unfallkrankenhaus Berlin
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallowing quality of saliva (speed of laryngeal elevation) | 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. |
| Change in swallowing quality of saliva (time of pharyngeal closure during swallowing) | 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. |
| Change in swallowing quality of saliva (pumping jaw movements before swallowing) | 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. |
| Change in swallowing frequency of saliva. | 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. |
| Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to eat and drink | Baseline and three weeks | Scored on the Functional Oral Intake Scale (FOIS) |
| Severity of Dysphagia | Baseline and three weeks | Scored on the Penetration Aspiration Scale (PAS) during Fiberoptic Endoscopic Evaluation of Swallowing |
Outcome results
None listed