Clinical trial NCT05729165: Local Vibration in Patients with Severe Acquired Brain Injury
Official title: Local Vibration Therapy and Traditional Speech Therapy for Dysphagia in Patients with Severe Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Dysphagia
Keywords: Acquired Brain Injury
Dysphagia
Local vibration
Technological Rehabilitation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, randomized, parallel assigment
Primary purpose: TREATMENT

Brief summary: Severe Acquired Brain Injury (sABI), with a more or less prolonged state of coma, generally causes disruption of the physiological modes of swallowing and feeding and the physiological abilities of communication and phonation.

There is broad agreement in the scientific literature for early intervention by the entire rehabilitation team. In the specific case of swallowing and phonatory function, speech therapist intervention is indicated with the goal of restoring the automatic and voluntary movements of the muscles involved in the performance of the previously mentioned functions.

Speech-language treatment of buccal structures, sensation, motor and praxie is recommended in conjunction with other types of approaches (dietary modifications, compensation techniques, postural modifications).

In the acute and early subacute phase of patients with sABI with a vigilance level of less than 4 according to the Levels of Cognitive Functioning scale, alterations in bucco-linguo-facial structures and swallowing can be observed that prevent the execution of a correct motor pattern of phonation and swallowing. For this reason, passive and/or active stimulation aimed at restoring sensitivity, strength, and movement coordination of the bucco-linguo-facial and laryngeal muscles is necessary to rehabilitate the prerequisites for the initiation of feeding, to restore adequate afferents, and to stimulate communication.

A careful search of the literature shows that over the past decade many studies in the rehabilitation field have sought to understand the effects of local vibration therapy at various levels of the central nervous system and the possible benefits in neurorehabilitation. From a speech therapy perspective, there are only three studies on the area of dysphonia in cases of upper laryngeal nerve palsy, combining traditional treatment with the use of Novafon®, a sound wave medical device used for Local Vibrational Therapy. The results show greater improvements in vocal function and voice quality when classical treatment is combined with Local Vibrational Therapy. These studies conclude by affirming the need for further research with a larger sample size to analyze the potential effectiveness of Novafon® applied to the recovery of vocal cord paralysis.

Detailed description: The purpose of the present study is to observe the effects of integrating traditional speech therapy with the new intervention modality of local vibration therapy with Novafon® in patients with sABI.

Specifically, this study aims to:

(i) Observe and record an increase in trophism of the muscles involved; (ii) improve swallowing and phonatory functions. Twenty-four patients of both sexes with sABI will be recruited, evaluated and treated at the UOC of High Intensity Neurorehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.

Participants included in the study will be randomized into two groups according to a computer-generated sequence: patients in the experimental group (S-G) will perform traditional speech therapy combined with speech therapy using Novafon®; patients in the conventional group (C-G) will perform only traditional speech therapy.

The experimental rehabilitation treatment will be carried out at the rate of once a day, 5 days a week for a total of 8 weeks. Each speech therapy session will last a total of 40 minutes.

The rehabilitation treatment will be carried out in the room of the patient, who will be placed in a sitting position in a wheelchair or bed, with the backrest inclined at least 45°.

Eligibility criteria: Inclusion Criteria:

* Previous coma
* Age between 18 and 90 years
* Level of consciousness greater than or equal to Minimally Conscious State plus
* Feeding through SNG or PEG
* Clinical stability
* Ability of caregiver/legal guardian to understand and sign informed consent

Exclusion Criteria:

- Psychiatric or other conditions that may affect patient compliance with treatment

Primary outcomes:
measure: Dysphagia Outcome and Severity Scale (DOSS)
timeFrame: Change from baseline DOSS at 4 and 8 weeks
Secondary outcomes:
measure: Bedside Swallow Assessment scale (BSAs)
timeFrame: Change from baseline BSAs at 4 and 8 weeks
measure: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
timeFrame: Change from baseline FEES at 4 and 8 weeks
measure: Phonation
timeFrame: Change from baseline phonation at 4 and 8 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Luca Padua, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: