Local Vibration in Patients with Severe Acquired Brain Injury

NCT ID: NCT05729165

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2024-06-01

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°.

Conditions

Acquired Brain Injury; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group (S-G)

20 minutes of local vibration treatment with the Novafon® Pro medical device followed by 20 minutes of traditional speech therapy, for a total duration of 40 minutes. Therefore, using this instrument, local vibration therapy will be applied at the level of (i) the orbicular muscles of the upper and lower lips, (ii) the masticatory muscles (masseter, temporalis, pterygoid), and (i) local intra-oral and tongue. The Novafon® Pro medical device will be used with the following external and intraoral heads: set senses roller, ball head, disc head, ball head, arrow head, spoon head, and tongue depressor head.

Traditional speech therapy treatment will be carried out with the same tools and activities already described in the C-G.

Group Type: EXPERIMENTAL

Novafon® Pro

Intervention Type: 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

Intervention Type: 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.

Control group (C-G)

40 minutes of conventional speech treatment. Specifically, maneuvers will be performed for (i) extra-oral and intra-oral passive thermal stimulation, (ii) extra-oral and intra-oral passive tactile stimulation, and for (iii) elicitation of active bucco-lingual and laryngeal muscle movements. The following instruments will be used for this purpose: ice cubes, ice tubes, sterile gauze, tongue depressors, swabs, 10 mm laryngeal mirrors.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: 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.

Interventions

Novafon® Pro

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.

Intervention Type: DEVICE

Conventional Therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

PADUA LUCA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Padua, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Countries

Italy

Other Identifiers

0038189/21

Identifier Type: -

Identifier Source: org_study_id