Lee Silverman Voice Treatment Versus Standard Speech and Language Therapy Versus Control in Multiple Sclerosis: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in intensity measured in decibel (dB) of three functional sentences
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lee Silverman Voice Therapy
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.
Intervention: Lee Silverman Voice Therapy (Other)
Conventional Treatment
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: Conventional Treatment (Other)
Outcomes
Primary Outcomes
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".
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".
Secondary Outcomes
- Change in Maximum Phonation Time (MPT) of three sustained /ah/ (sec.)(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(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(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))
Investigators
Davide Cattaneo
Research Coordinator Larice Lab.
Fondazione Don Carlo Gnocchi Onlus