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

NCT04034277 | Unknown

• 1 other identifier: SM_Voice_RCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Voice Disorders; Speech and language therapy; Lee Silverman voice treatment

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• 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 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)

• 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)

Study Arms (2)

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.

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

Other: Conventional Treatment

Interventions

Lee Silverman Voice Therapy OTHER

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

Lee Silverman Voice Therapy

Conventional Treatment OTHER

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.

Conventional Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Gnocchi Irccs

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Voice Disorders; Communication Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria Carrozza, PhD

  Fondazione Don C. Gnocchi

  STUDY DIRECTOR

Central Study Contacts

Davide Cattaneo, PhD

CONTACT

+390240308; dcattaneo@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator Larice Lab.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: January 15, 2018
• Primary Completion: September 30, 2019
• Study Completion: March 30, 2020
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

IT (1)