Clinical trial NCT04034277: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Voice Disorders
Speech and language therapy
Lee Silverman voice treatment
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in intensity (dB) of 3 sustained /ah/
timeFrame: 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)
measure: Change in intensity measured in decibel (dB) of three functional sentences
timeFrame: 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)
measure: Change in intensity in conversation measured in decibel (dB)
timeFrame: 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:
measure: Change in Maximum Phonation Time (MPT) of three sustained /ah/ (sec.)
timeFrame: 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)
measure: Change in Vocal Handicap Index
timeFrame: 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)
measure: Change in GIRBAS
timeFrame: 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)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Gnocchi Irccs
Study officials:
affiliation: Fondazione Don C. Gnocchi
name: Maria Carrozza, PhD
role: STUDY_DIRECTOR
References: