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

NCT ID: NCT05930379

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2024-09-01

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.

Detailed Description

20 patients with MS will be recruited from IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, according to inclusion/exclusion criteria detailed in the "Eligibility Criteria" section.

Participants will be randomized into 2 different groups:

Group 1: Lee Silverman Voice Treatment - Loud delivered by telerehabilitation at home (Experimental group); Group 2: Lee Silverman Voice Treatment - Loud delivered in the clinic (Control group).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LSVT-Loud delivered by telerehabilitation

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.

Group Type: EXPERIMENTAL

LSVT-Loud delivered by telerehabilitation

Intervention Type: OTHER

LSVT-Loud treatment delivered by telerehabilitation

LSVT-Loud in the clinic

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.

Group Type: ACTIVE_COMPARATOR

LSVT-Loud in the clinic

Intervention Type: OTHER

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

Interventions

LSVT-Loud delivered by telerehabilitation

LSVT-Loud treatment delivered by telerehabilitation

Intervention Type: OTHER

LSVT-Loud in the clinic

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Sclerosi Multipla

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Don Gnocchi ONLUS

Milan, Italy/Milan, Italy

Countries

Italy

Other Identifiers

ON-LOUD

Identifier Type: -

Identifier Source: org_study_id