NCT05930379Completed
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 26 Jun 2023
- Start date
- 10 Jun 2023
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Multiple sclerosis
- NCT number
- NCT05930379
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 10 Jun 2023 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Don Gnocchi ONLUS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.