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Completed

NCT Number: NCT05729165

Local Vibration in Patients with Severe Acquired Brain Injury

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.

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

About this study

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°.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novafon® Pro

Device

Local vibration therapy. The target muscles were: the orbicularis muscles of the upper and lower lips, the masticatory muscles (masseter, temporalis, pterygoidis) and lingual muscles.

Conventional Therapy

Other

maneuvers were performed for passive extra-oral and intra-oral thermal stimulation, passive extra-oral and intra-oral tactile stimulation, and elicitation of active movements of the bucco-lingual and pharyngo-laryngeal muscles.

Primary outcomes

  1. Dysphagia Outcome and Severity Scale (DOSS)

    Time frame: Change from baseline DOSS at 4 and 8 weeks

    DOSS is a 7-point functional dysphagia rating scale (from 1 severe dysphagia with the need for artificial feeding, to 7 swallowing in the normal range and exclusive oral feeding), which provides recommendations regarding the type of diet/nutrition to be followed and the level of independence. The progress of this 7-point scale reflects an improvement in the level of dependence in feeding (form 0, "total dependence" to 7, "self-sufficient patient"), level of nutrition (levels 7-3 full oral nutrition and levels 2-1 non-oral nutrition) and type of diet according to different food consistencies (levels 7-6 normal diet consistency, level 5 may need one diet consistency restriction, level 4 one to two diet consistency restrictions, and level 3 two or more diet consistency restrictions). The aspects considered by this scale are bolus management in the oral phase, pharyngeal phase retention and ability to protect the airway.

Secondary outcomes

  1. Bedside Swallow Assessment scale (BSAs)

    Time frame: Change from baseline BSAs at 4 and 8 weeks

    BSAs is a tool with a minimum score of 19 in case of adequate swallowing function and a maximum score of 48 indicating severe discomfort. It is divided into three parts:

    • level of consciousness, trunk and head control, respiration, structures of the phono-articulatory and swallowing apparatus;
    • direct evaluation of swallowing by administering 5 ml of water and recording laryngeal movements with attempts to swallow, repetitive movements, the presence or absence of coughing during swallowing and the presence of gurgling voice after swallowing;
    • administration of 60 ml of water, recording the time required to finish, the number of sips, the presence of coughing, the presence of gurgling voice.

    A scale value < 19 reflects the inability to perform part of the tests, particularly the third part with water administration, due to risk of aspiration, inability or lack of cooperation from the patient.

  2. Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

    Time frame: Change from baseline FEES at 4 and 8 weeks

    FEES is a highly sensitive and useful examination to obtain information on the anatomical rhino-pharyngeal-laryngeal structures, swallowing mechanism, pharyngeal motility, and sensitivity of the pharyngeal-laryngeal tract. FEES does not allow direct verification of whether aspiration is present, but the risk of aspiration can be detected by the presence of post-deglutition stagnation in the laryngeal vestibule.

  3. Phonation

    Time frame: Change from baseline phonation at 4 and 8 weeks

    Phonation will be assessed through the use of a sound level meter, an instrument that can identify the decibels (dB) of phonation.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Local Vibration Therapy and Traditional Speech Therapy for Dysphagia in Patients with Severe Acquired Brain Injury

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Feb 15, 2023
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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