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Local Vibration in Patients With Severe Acquired Brain Injury

Primary Purpose

Acquired Brain Injury, Dysphagia

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Novafon® Pro
Conventional Therapy
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring Acquired Brain Injury, Dysphagia, Local vibration, Technological Rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group (S-G)

Control group (C-G)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dysphagia Outcome and Severity Scale (DOSS)
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 Outcome Measures

Bedside Swallow Assessment scale (BSAs)
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.
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
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.
Phonation
Phonation will be assessed through the use of a sound level meter, an instrument that can identify the decibels (dB) of phonation.

Full Information

First Posted
February 6, 2023
Last Updated
February 15, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05729165
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

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

5. Study Description

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°.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Dysphagia
Keywords
Acquired Brain Injury, Dysphagia, Local vibration, Technological Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional, randomized, parallel assigment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (S-G)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (C-G)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Novafon® Pro
Intervention Description
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
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
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 Outcome Measure Information:
Title
Dysphagia Outcome and Severity Scale (DOSS)
Description
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.
Time Frame
Change from baseline DOSS at 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Bedside Swallow Assessment scale (BSAs)
Description
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.
Time Frame
Change from baseline BSAs at 4 and 8 weeks
Title
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Description
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.
Time Frame
Change from baseline FEES at 4 and 8 weeks
Title
Phonation
Description
Phonation will be assessed through the use of a sound level meter, an instrument that can identify the decibels (dB) of phonation.
Time Frame
Change from baseline phonation at 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Padua, MD, phD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Local Vibration in Patients With Severe Acquired Brain Injury

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