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A Feasibility Pilot Study on Lee Silverman Voice Treatment (LSVT)-Loud on Voice Intensity and Voice Use in Daily Living in People With Multiple Sclerosis: a Telerehabilitation Approach
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.
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).
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Fondazione Don Gnocchi ONLUS
Milan, Italy/Milan, Italy
Start Date
June 10, 2023
Primary Completion Date
September 1, 2024
Completion Date
September 1, 2024
Last Updated
September 4, 2025
20
ACTUAL participants
LSVT-Loud delivered by telerehabilitation
OTHER
LSVT-Loud in the clinic
OTHER
Lead Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
NCT07225504
NCT06276634
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192