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

Multiple Sclerosis Clinical Trial

Official title:

Lee Silverman Voice Treatment Versus Standard Speech and Language Therapy Versus Control in Multiple Sclerosis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034277
• Other study ID #: SM_Voice_RCT
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Davide Cattaneo, PhD
• Phone: +390240308
• Email: dcattaneo[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Lee Silverman Voice Therapy
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 Treatment
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.

Locations

Country	Name	City	State
Italy	Fondazione Don Gnocchi Irccs	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	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)
Primary	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".	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)
Primary	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".	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	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".	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	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.	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	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.	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)