NCT05930379

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	LSVT-Loud delivered by telerehabilitation	LSVT-Loud treatment delivered by telerehabilitation
OTHER	LSVT-Loud in the clinic	LSVT-Loud delivered face-to-face in the clinic

Timeline

• Start date: 2023-06-10
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-07-05
• Last updated: 2025-09-04

Locations

1 site across 1 country: Italy