CompletedNot Applicable

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

Italy20 participantsStarted 2023-06-10

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, post-treatment (up to 4 weeks)

Trial details

NCT IDNCT05930379

SponsorFondazione Don Carlo Gnocchi ETS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Multiple Sclerosis trials