Multiple SclerosisNCT04034277
Lee Silverman Voice Treatment Versus Standard Speech Therapy Versus Control in Hypophonia Rehabilitation in MS
A study testing Lee Silverman Voice Therapy and Conventional Treatment in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lee Silverman Voice Therapy and Conventional Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Gnocchi Irccs
Milan
DAVIDE CATTANEO, PhD
About this study
Official title: Lee Silverman Voice Treatment Versus Standard Speech and Language Therapy Versus Control in Multiple Sclerosis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Lee Silverman Voice Therapy, Conventional Treatment
- Keywords
- Voice Disorders, Speech and language therapy, Lee Silverman voice treatment
- Medical subject headings
- Multiple Sclerosis, Voice Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lee Silverman Voice TherapyOther
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
Conventional TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lee Silverman Voice Therapy | Experimental | 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. Receives: Other: Lee Silverman Voice Therapy |
| Conventional Treatment | Active comparator | 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 Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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)
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".
Measured: 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)
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".
Measured: 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 outcomes (3)
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".
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start15 Jan 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Cattaneo, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Maria Carrozza, PhD, Study director, Fondazione Don C. Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034277
- Sponsor's protocol ID
- SM_Voice_RCT
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lee Silverman Voice Treatment Versus Standard Speech and Language Therapy Versus Control in Multiple Sclerosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04034277
- Acronym / sponsor ID
- SM_Voice_RCT
- Conditions
- Multiple Sclerosis
- Keywords
- Voice Disorders, Speech and language therapy, Lee Silverman voice treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lee Silverman Voice Therapy | Experimental | Other: Lee Silverman Voice TherapyLSVT 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. |
| Conventional Treatment | Active comparator | Other: Conventional TreatmentThe 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lee Silverman Voice TherapyLSVT 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 | Other | Lee Silverman Voice Therapy |
| Conventional Treatmentspeech 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. | Other | Conventional Treatment |
Primary outcome
Change in intensity (dB) of 3 sustained /ah/
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)
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
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)
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)
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)
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".
3 secondary outcomes
Change in Maximum Phonation Time (MPT) of three sustained /ah/ (sec.)
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)
Change in Vocal Handicap Index
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)
Change in GIRBAS
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
Related trials for Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Carrozza, PhD study director
Fondazione Don C. Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lee Silverman Voice Therapy and Conventional Treatment in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Cattaneo, PhD (+390240308 ext. 814, dcattaneo@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intensity (dB) of 3 sustained /ah/ (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.