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Lee Silverman Voice Treatment Versus Standard Speech Therapy Versus Control in Hypophonia Rehabilitation in MS

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lee Silverman Voice Therapy
Conventional Treatment
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Voice Disorders, Speech and language therapy, Lee Silverman voice treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Multiple Sclerosis according with McDonald's criteria;
  • absence of relaps in the last month;
  • Mini Mental State Examination (MMSE) > 21 score for a better understanding and adherence to the execution of the proposed exercises;
  • hypophonia (conversation < 60 dB SPL- distance was kept equal at about 15 cm);
  • ability to understand the aims of the study and acceptance to sign an informed consent;
  • acceptance of the intensity of the treatment;
  • ability to understand the Italian language.

Exclusion Criteria:

  • Presence of other neurological disorders;
  • visual/hearing impairments hindering the rehabilitation program;
  • clinical history of laryngeal cancer, chemotherapy, radiotherapy, head and neck trauma or endotracheal intubation;
  • relapse or sudden changes in their MS symptoms within the previous 3 months.

Sites / Locations

  • Fondazione Don Gnocchi IrccsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lee Silverman Voice Therapy

Conventional Treatment

Arm Description

LSVT LOUD® is a therapy program which requires four sessions per week for 4 weeks by a speech and language therapists with a certification in Lee Silverman Voice Therapy. Each session lasted 50-60 min.

The content and dose of standard SLT is poorly defined within the published literature. For this reason, the standard therapy intervention will encompass all SLT techniques that are not LSVT®. Treatment will be individualized and may include any of the following: exercises targeting respiration, phonation, articulation, behavioral strategies to reduce prosodic abnormality

Outcomes

Primary Outcome Measures

Change in intensity (dB) of 3 sustained /ah/
All subjects were requested to sustain the vowel /ah/ as long as possible at a comfortable frequency and maximum intensity level. Specific task was given: "Please and say /ah/. Make it strong and steady, and sustain it for as long as you can".
Change in intensity measured in decibel (dB) of three functional sentences
all speakers were requested to produce three functional sentences at a comfortable frequency and maximum intensity level. The sentences were the same for all subjects. Specific tasks, identical for each individual, was given: "Please take a deep breath and repeat each sentences with effort voice".
Change in intensity in conversation measured in decibel (dB)
A speech sample of approximately one minute of spontaneous conversation was recorded and measured in dB in order to analyze speech intensity. Specific tasks, identical for each individual, was given: "Please speak for at least a minute".

Secondary Outcome Measures

Change in Maximum Phonation Time (MPT) of three sustained /ah/ (sec.)
All subjects were requested to sustain the vowel /ah/ as long as possible at a comfortable frequency and maximum intensity level. Specific tasks, identical for each individual, was given: "Please and say /ah/. Make it strong and steady, and sustain it for as long as you can".
Change in Vocal Handicap Index
Voice Handicap Index (VHI) is a self-assessed standardized 30-point questionnaire, which includes items on the impact of the voice disorder on daily life. The questionnaire is divided into three subscales covering functional, emotional and physical aspect of voice disorders. Each answer is graded 0 to 4 depending on the frequency of the difficulty: 0 no difficulties, 1 almost never, 2 sometimes, 3 almost always, 4 always.
Change in GIRBAS
Tool used to quantify perceptual evaluation of the voice quality. The scale evaluates in particular 5 aspects of voice: Grade, Instability, Roughness, Breathiness, Asthenia, and Strain. Voice quality was assessed by a trained speech therapist, using a scale from 0 to 3 where 0 regular, 1 mildly pronounced, 2 moderate, 3 very pronounced.

Full Information

First Posted
July 24, 2019
Last Updated
July 24, 2019
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT04034277
Brief Title
Lee Silverman Voice Treatment Versus Standard Speech Therapy Versus Control in Hypophonia Rehabilitation in MS
Official Title
Lee Silverman Voice Treatment Versus Standard Speech and Language Therapy Versus Control in Multiple Sclerosis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

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
The aim of the study is to identify the most effective method of intervention to reduce hypophonia in PwMS (Patient With Multiple Sclerosis), as a way to optimize the speech-therapy treatment based on scientific evidence. In the previous AB study, we aimed to verify the efficacy of LSVT LOUD® in PwSM: in the present study we will compare different treatment in a larger sample. Half of the participants will follow the LSVT Loud program, the other half will follow usual care rehabilitation programs. The results of these groups will be compared with an historical cohort of no treatment patients.
Detailed Description
The descriptive studies showed that voice problems, in particular hypophonia, are present in 45% to 91% of patients with multiple sclerosis and may constitute a limitation in social life participation. Although voice, speech and communication are significant aspects for the biopsychosocialwell-being and life quality, only 2% of the PwMS had received any speech therapy and, at the same time, few studies assessed the effects of speech treatment for PwMS. In according to the taxonomy of voice therapy, the conventional treatment may include direct interventions such as vocal function and modification of respiratory function. The LSVT LOUD® treatment is a standardized, research-based speech treatment protocol with established efficacy for Idiopathic Parkinson Disease (IPD) and is well described in a large number of studies. Subsequently, further studies supported the efficacy of LSVT LOUD® in voice rehabilitation in various neurological diseases, including Multiple Sclerosis. In the study of Sapir et al., only two women were treated with LSVT LOUD® and the authors concluded that intensive phonatory-respiratory treatment can produce clinically significant and long-term improvement in vocal function in PwMS. These findings are consistent with suggestion that intensive training can improve function in those parts of the body that are prone to fatigue and that vocal training probably minimizes disuse atrophy and increases muscle strength and coordination. The content and dose of the SLT (Speech Language Therapy) of dysphonia in MS is poorly defined within the published literature and we did not find any meta-analyzes or guidelines that suggest instructions for therapists. The purpose of this project is to identify the most effective method of intervention to reduce hypophonia in PwMS, as a way to optimize the speech-therapy treatment based on scientific evidence. The data in literature suggest that LSVT LOUD® may be functional for these aims, although there isn't broad-based study with PwSM. Fourty Persons with Multiple Sclerosis will be randomly allocated to an experimental group (Lee Silverman Voice Treatment - LSVT LOUD® method) or to a control group following usual care rehabilitation programs. Also an historical cohort of untreated patients was considered (voice assessment: baseline, after 4 weeks, FU-Follow Up at 6/12 months). Data collection in both groups will be performed at baseline, after 4 weeks of treatment and after 6-12 months up to the end of the rehabilitation program (FU). In order to evaluate the perceptual impact of the treatment, GIRBAS and VHI will be proposed. The acoustic variables will be recorded with the software PRAAT: SPL (Sound Pressure Level) of a sustained /ah/, SPL of functional sentences, maximum phonation time, SPL of 1 minute monologue. In addition, the following values were taken in the minute of spontaneous speech: Jitter, shimmer, fundamental frequency, maximum frequency and minimum frequency. The type of MS, Expanded Disability Status Scale (EDSS) , demographic data, disease duration, presence of postural and respiratory problems, presence of depression (Beck Depression Inventory-II - BDI II) , pharmacological treatment and cognitive status (Brief Repeatable Battery of Neuropsychological Tests) will be considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Voice Disorders, Speech and language therapy, Lee Silverman voice treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lee Silverman Voice Therapy
Arm Type
Experimental
Arm Description
LSVT LOUD® is a therapy program which requires four sessions per week for 4 weeks by a speech and language therapists with a certification in Lee Silverman Voice Therapy. Each session lasted 50-60 min.
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
The content and dose of standard SLT is poorly defined within the published literature. For this reason, the standard therapy intervention will encompass all SLT techniques that are not LSVT®. Treatment will be individualized and may include any of the following: exercises targeting respiration, phonation, articulation, behavioral strategies to reduce prosodic abnormality
Intervention Type
Other
Intervention Name(s)
Lee Silverman Voice Therapy
Intervention Description
LSVT LOUD® comprises maximum effort non-speech and speech drills. The non-speech drills include the production of 15 sustained 'ah' phonation at high volume and pitch glides (5 repetitions moving from modal pitch to high pitch and 15 repetitions moving from modal pitch and going down on production of sustained 'ah'). The speech drills utilize a hierarchy of speech tasks moving from single words through phrases and onto conversational speech to generalize
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
speech rehabilitation protocol comprehend: Respiratory and phonatory exercises: exercises to increase diaphragmatic and respiratory functions, exercises to increase expiration time using natural expiration or sibilant, exercise to increase phonation time by pronouncing the vocal /a/, exercise to reduce oral stiffness. Articulation and prosody exercises: repetition or reading lists of possibly long and complex words that start with or contain consonants groups. Read aloud texts, sentences or words, making sure to articulate and pronounce the words well without diminishing or increasing the rhythm of speech, with the correct punctuation and intonation. If necessary, ask patients to hyperarticulate, accelerate or slow down, or exaggerate intonation.
Primary Outcome Measure Information:
Title
Change in intensity (dB) of 3 sustained /ah/
Description
All subjects were requested to sustain the vowel /ah/ as long as possible at a comfortable frequency and maximum intensity level. Specific task was given: "Please and say /ah/. Make it strong and steady, and sustain it for as long as you can".
Time Frame
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Title
Change in intensity measured in decibel (dB) of three functional sentences
Description
all speakers were requested to produce three functional sentences at a comfortable frequency and maximum intensity level. The sentences were the same for all subjects. Specific tasks, identical for each individual, was given: "Please take a deep breath and repeat each sentences with effort voice".
Time Frame
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Title
Change in intensity in conversation measured in decibel (dB)
Description
A speech sample of approximately one minute of spontaneous conversation was recorded and measured in dB in order to analyze speech intensity. Specific tasks, identical for each individual, was given: "Please speak for at least a minute".
Time Frame
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Secondary Outcome Measure Information:
Title
Change in Maximum Phonation Time (MPT) of three sustained /ah/ (sec.)
Description
All subjects were requested to sustain the vowel /ah/ as long as possible at a comfortable frequency and maximum intensity level. Specific tasks, identical for each individual, was given: "Please and say /ah/. Make it strong and steady, and sustain it for as long as you can".
Time Frame
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Title
Change in Vocal Handicap Index
Description
Voice Handicap Index (VHI) is a self-assessed standardized 30-point questionnaire, which includes items on the impact of the voice disorder on daily life. The questionnaire is divided into three subscales covering functional, emotional and physical aspect of voice disorders. Each answer is graded 0 to 4 depending on the frequency of the difficulty: 0 no difficulties, 1 almost never, 2 sometimes, 3 almost always, 4 always.
Time Frame
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Title
Change in GIRBAS
Description
Tool used to quantify perceptual evaluation of the voice quality. The scale evaluates in particular 5 aspects of voice: Grade, Instability, Roughness, Breathiness, Asthenia, and Strain. Voice quality was assessed by a trained speech therapist, using a scale from 0 to 3 where 0 regular, 1 mildly pronounced, 2 moderate, 3 very pronounced.
Time Frame
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)

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: Diagnosis of Multiple Sclerosis according with McDonald's criteria; absence of relaps in the last month; Mini Mental State Examination (MMSE) > 21 score for a better understanding and adherence to the execution of the proposed exercises; hypophonia (conversation < 60 dB SPL- distance was kept equal at about 15 cm); ability to understand the aims of the study and acceptance to sign an informed consent; acceptance of the intensity of the treatment; ability to understand the Italian language. Exclusion Criteria: Presence of other neurological disorders; visual/hearing impairments hindering the rehabilitation program; clinical history of laryngeal cancer, chemotherapy, radiotherapy, head and neck trauma or endotracheal intubation; relapse or sudden changes in their MS symptoms within the previous 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Cattaneo, PhD
Phone
+390240308
Ext
814
Email
dcattaneo@dongnocchi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Carrozza, PhD
Organizational Affiliation
Fondazione Don C. Gnocchi
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Don Gnocchi Irccs
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAVIDE CATTANEO, PhD

12. IPD Sharing Statement

Learn more about this trial

Lee Silverman Voice Treatment Versus Standard Speech Therapy Versus Control in Hypophonia Rehabilitation in MS

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