A Feasibility Pilot Study on Lee Silverman Voice Treatment-Loud: a Telerehabilitation Approach

NCT05930379 | Completed

• 1 other identifier: ON-LOUD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is one of the most common causes of neurological disability in young adults. At least 62% of people with MS have speech, vocal, or communication disorders. Among these, alterations in voice intensity and quality constitute a limitation in MS people's social life leading to experience difficulties in work, conversations, and communication especially in noisy environments or through the telephone. Though voice and speech impairments and speech impairments are widely prevalent in this population, only 2% of the people receive speech therapy. The Lee Silverman Voice Treatment (LSVT)-Loud is a well-documented, efficacious intensive speech intervention, for treating hypophonia in subjects with neurological conditions. Despite the effectiveness of LSVT-Loud treatment on the voice has been reported in MS, several factors prevent the agile use of this method in rehabilitation centers: motor disability, work commitments, and distance barriers may preclude repeated attendance of this intervention at a healthcare facility. Telerehabilitation represents a feasible solution to bypass these potential barriers related to attendance at the rehabilitation programs in the clinic. The increasing evidence sustains the role of telerehabilitation for the migration of care from the clinic to the patient's homes, overcoming several obstacles affecting service accessibility. Previous studies showed the validity and the non-inferiority of LSVT-Loud delivered via telerehabilitation in subjects with Parkinson's Disease, while no pieces of evidence are still available on the efficacy of voice treatment delivered by telerehabilitation in MS. It is plausible to assume that LSVT-Loud delivered by telerehabilitation would be feasible and provide a beneficial effect also for MS non-inferior compared to the same treatment delivered in the clinic.

Conditions

Multiple Sclerosis

Keywords

Telerehabilitation; Speech Therapy; Multiple Sclerosis; Voice Intensity; Hypophonia; Digital Health

Outcome Measures

Primary Outcomes (1)

• Change in the vocal Intensity during 1-minute monologue dB SPL

  Participants will be requested to speak about daily activities at a comfortable frequency and intensity level. A specific task identical for each participant will be given: "Please speak for at least a minute." For monologue (and other acoustic variables described below) recording setup follows published recommendations, mouth-to-microphone distance is kept at 30 cm and we will calculate the mean of the first three recordings and PRAAT software (www.praat.org) will be used to record and analyze voice parameters.

  Baseline, post-treatment (up to 4 weeks)

Secondary Outcomes (5)

• Change in the vocal Intensity during 1-minute monologue dB SPL

  follow-up (up to 6 months from the end of the treatment)

• Change in sustained /a/ voice intensity (dB SPL/a/)

  Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment)

• Change in the perception of voice as measured by the Voice Handicap Index (VHI, Jacobson et al., 1997)

  Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment

• hange in perceived quality of life (especially in cognition, life activities, and participation domain) as measured by the World Health Organization disability assessment schedule 2.0 (WHODAS 2.0; Federici et al., 2017)

  Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment

• Protocol adherence

  post-treatment (up to 4 weeks)

Other Outcomes (4)

• Technological Systems interaction perceived experience as measured by the User Experience Questionnaire (UEQ; Schrepp et al., 2017)

  post-treatment (up to 4 weeks)

• Intrinsic Motivation in the rehabilitation program as measured by the Intrinsic Motivation Inventory - Interest/Enjoyment subscale (IMI-IE; McAuley et al., 1989)

  post-treatment (up to 4 weeks)

• Number of adverse events

  post-treatment (up to 4 weeks)

Study Arms (2)

LSVT-Loud delivered by telerehabilitation

EXPERIMENTAL

F - Frequency: 7 times/week for 4 weeks according to a mixed model (4 days of synchronous sessions followed by independent practice + 3 asynchronous sessions); I - Intensity: sessions customized according to the patient's functional abilities to ensure the progression of difficulty in rehabilitation sessions; T- Time: each synchronous session will last about 60 minutes, each independent practice will last about 5-10 minutes, and each asynchronous session will last about 30 minutes; T- Type: Individual speech therapy sessions with the Lee Silverman Voice Treatment-Loud method delivered by telerehabilitation.

Other: LSVT-Loud delivered by telerehabilitation

LSVT-Loud in the clinic

ACTIVE COMPARATOR

The frequency, intensity, time of the rehabilitation sessions will be the same as the experimental group. T- Type: Individual speech therapy sessions with the Lee Silverman Voice Treatment-Loud method delivered in the clinic.

Other: LSVT-Loud in the clinic

Interventions

LSVT-Loud delivered by telerehabilitation OTHER

LSVT-Loud treatment delivered by telerehabilitation

LSVT-Loud delivered by telerehabilitation

LSVT-Loud in the clinic OTHER

LSVT-Loud delivered face-to-face in the clinic

LSVT-Loud in the clinic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of MS according to the criteria of MC Donald 2010 (Polman et al., 2011; Thompson et al., 2018)
• perceived voice intensity disability and severity of speech and voice disorder prior to treatment (as judged independently by two speech-language pathologists highly experienced with voice and motor speech disorders)
• age ≥ 18;
• not treated for hypophonia in the six months before enrollment in the study
• with a preserved cognitive level at the Mini-Mental State Examination (MMSE test \>24) (Folstein et al., 1975);
• available and able to use a PC with an internet connection at home to access the telerehabilitation sessions;
• agreeing to participate with the signature of the informed consent form;
• stable drug treatment (last 3 months), if any;
• absence of relapses (last month) before taking part in the study.

You may not qualify if:

• presence of dysphonia related to other diseases;
• presence of other neurological disorders different from MS;
• presence of major psychiatric conditions;
• presence of severe impairment of visual and/or acoustic perception;
• history of laryngeal cancer, radiotherapy, or head-neck trauma, or intubation.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Italiana Sclerosi Multipla: collaborator

Study Sites (1)

Fondazione Don Gnocchi ONLUS

Milan, Italy/Milan, 20148, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; 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; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

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: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: June 10, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 4, 2025

Record last verified: 2024-12

Locations

IT (1)