Clinical trial NCT05930379: A Feasibility Pilot Study on Lee Silverman Voice Treatment-Loud: a Telerehabilitation Approach
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Telerehabilitation
Speech Therapy
Multiple Sclerosis
Voice Intensity
Hypophonia
Digital Health
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Fondazione Italiana Sclerosi Multipla
First posted: 2023-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in the vocal Intensity during 1-minute monologue dB SPL
timeFrame: Baseline, post-treatment (up to 4 weeks)
Secondary outcomes:
measure: Change in the vocal Intensity during 1-minute monologue dB SPL
timeFrame: follow-up (up to 6 months from the end of the treatment)
measure: Change in sustained /a/ voice intensity (dB SPL/a/)
timeFrame: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment)
measure: Change in the perception of voice as measured by the Voice Handicap Index (VHI, Jacobson et al., 1997)
timeFrame: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment
measure: hange in perceived quality of life (especially in cognition, life activities, and participation domain) as measured by the World Health Organization disability assessment schedule 2.0 (WHODAS 2.0; Federici et al., 2017)
timeFrame: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment
measure: Protocol adherence
timeFrame: post-treatment (up to 4 weeks)
Other outcomes:
measure: Technological Systems interaction perceived experience as measured by the User Experience Questionnaire (UEQ; Schrepp et al., 2017)
timeFrame: post-treatment (up to 4 weeks)
measure: Intrinsic Motivation in the rehabilitation program as measured by the Intrinsic Motivation Inventory - Interest/Enjoyment subscale (IMI-IE; McAuley et al., 1989)
timeFrame: post-treatment (up to 4 weeks)
measure: Number of adverse events
timeFrame: post-treatment (up to 4 weeks)
measure: 4. Perceived rehabilitation engagement, acceptability, feasibility, frequency, and dose adequacy
timeFrame: post-treatment (up to 4 weeks)
Locations:
city: Milan
country: Italy
facility: Fondazione Don Gnocchi ONLUS
state: Italy/Milan
Study officials:
References: