Telerehabilitation for Lee Silverman Voice Treatment (Tele-LSVT)-Loud on voice intensity and voice use in daily living in people with multiple sclerosis: A protocol for a feasibility and pilot randomized controlled study.

Objective: Alterations in voice intensity and quality may constitute a social life limitation in people with multiple sclerosis (MS), but only 2% of cases receive speech therapy. Especially the Lee Silverman Voice Treatment (LSVT)-Loud is a highly effective intensive method for voice intensity, requiring subjects' repeated attendance at the clinic. Telerehabilitation may represent a feasible solution to bypass potential barriers related to speech therapy attendance, scaling up the beneficial effects of the treatment to a broader population. The proposed protocol aims to test the feasibility and the pilot efficacy of the LSVT-Loud delivered in telerehabilitation (Tele-LSVT-Loud), compared to the same treatment delivered in the clinic (LSVT-Loud). Methods: A single-blinded, parallel, two-arm, pilot randomized (1:1 ratio) controlled trial will be performed involving 20 people with MS. Patients will be allocated to 4 weeks of Tele-LSVT-Loud by accessing a telerehabilitation platform at home or LSVT-Loud conventionally delivered in the clinic. Feasibility and pilot effectiveness will be evaluated three times: before (T0), after the treatment (T1), and 3-month follow-up (T2). Feasibility measures will include adherence, adverse events, user experience, motivation, engagement, and acceptability. Vocal intensity during a 1-minute monologue will be the primary outcome measure. Secondary outcome measures will be the vocal quality during a 1-minute monologue, sustained /a/ voice intensity, quality and stability, voice use in daily life, voice subjective perception in daily life, and quality of life. Results: Expected results will be (1) high feasibility of Tele-LSVT-Loud and (2) a non-inferiority effect of Tele-LSVT-Loud compared with face-to-face treatment delivery on voice intensity and quality outcomes. Conclusions: Tele-LSVT-Loud may be a feasible intervention for MS alteration in voice intensity and quality with a non-inferior effect compared to LSVT-Loud.

Factors Associated With Treatment-Related Changes in Voice Volume in People With Multiple Sclerosis.

BACKGROUND: Vocal disorders are frequent in people with multiple sclerosis (MS). Cognitive impairment, fatigue, depression, and other clinical characteristics can be associated with treatment effectiveness in rehabilitation. Finding baseline characteristics that identify those who are responding to treatment can help the clinical decision-making process, which can then help improve the effectiveness of voice treatment. We developed a model to identify factors associated with treatment-related improvement on voice intensity in people with MS. METHODS: Data are from a randomized controlled trial of the effects of voice therapy. Forty-four people with MS were enrolled and randomized to receive Lee Silverman Voice Treatment LOUD, specifically addressing voice intensity, or conventional speech-therapy group. Voice intensity (dB) was measured during monologue before and after treatment and was used to differentiate those who responded (posttreatment voice intensity > 60 dB) from those who did not. Possible associated factors were cognitive impairment, fatigue, depression, disability, and disease duration. Associations were assessed by univariate logistic regression and univariate and multivariate linear regressions. RESULTS: Mean ± SD monologue voice intensity is improved in the whole sample (before rehabilitation: 51.8 ± 4.2 dB; and after rehabilitation 57.0 ± 6.5 dB; P < .001), and 11 people with MS (27.5%) responded to treatment. Specificity of treatment was associated with the return to normal voice intensity (OR, 14.28; 95% CI, 12.17-309.56) and we found a linear association between voice improvement and the specificity of treatment (6.65 [SE = 1.54] dB; P < .05). Moreover, the analysis revealed a nonlinear association between improvement and fatigue, suggesting increased benefits for people with MS with moderate fatigue. Other factors were not significantly associated with treatment effectiveness. CONCLUSIONS: Moderate fatigue and the specificity of the intervention seem to be key factors associated with clinically relevant improvement in voice intensity even in people with MS with a high level of disability and long disease duration.

Effects of Intensive Voice Treatment (The Lee Silverman Voice Treatment [LSVT LOUD]) in Subjects With Multiple Sclerosis: A Pilot Study.

AIM: The rehabilitation of voice disorders is an unmet need in multiple sclerosis (MS). The Lee Silverman Voice Treatment (LSVT LOUD) is a well-documented and effective speech treatment, developed to treat voice disorders in Parkinson Disease. The purpose of the present study was to examine the viability of applying the LSVT LOUD to individuals with MS and verify short- and long-term improvements in acoustic and perceptual voice parameters. METHODS: A single subject design was performed in a consecutive sample of 8 subjects with MS. The subjects' voice was recorded with PRAAT software for 5 days at baseline during the 16  treatment sessions, and at follow-up (FU) 6/12 months later. PRAAT provided data on sustained /a/ (SPL/a/) voice intensity and maximum phonation time (MPT/a/) of sustained /a/, and on functional sentences voice intensity. In addition, self-assessment questionnaire Voice Handicap Index, the perceptual GIRBAS scale and intensity of monologue were collected at first day of baseline, post-treatment and at FU. In the treatment phase each subject received treatment according to LSVT LOUD protocol. Visual analysis calculated for daily acoustic variables was used to determine baseline stability and analyse changes following treatment. The Wilcoxon test was used to assess statistically significant differences between baseline and post treatment. RESULTS: All participants completed the LSVT LOUD programme; one participant dropped out at FU. Improvements in acoustic analysis were found: SPL/a/ improved on average (± standard deviation) 11.64 ± 4.19 dB with 7 subjects showing statistically significant improvement (P < 0.05); MPT/a/ improved on average 1.2 ± 1.53seconds, while intensity of functional sentences improved on average 8.11 ± 3.46  dB with 4 and 5 subjects showed statistically significant improvement, respectively. Intensity of monologue improved 14.90 ± 3.33 dB. Acoustic values are maintained or increased at FU respect to baseline. All subjects improved perceptual ratings at Voice Handicap Index and results were maintained at FU. These changes were associated with improvements on five parameters on the GIRBAS scale at post-treatment, however no further improvement were observed at FU. CONCLUSION: Intensive LSVT LOUD treatment is a viable approach to treat hypophonia in MS. LSVT LOUD improved both quantitative-instrumental and perceptive-subjective assessments. Randomised controlled trials are needed to provide a firm support on the effectiveness of LSVT LOUD in MS.

Effects of voice rehabilitation in people with MS: A double-blinded long-term randomized controlled trial.

BACKGROUND: Hypophonia is a prevailing problem in people with multiple sclerosis (PwMS). However, evidence supporting the effectiveness of voice rehabilitation is lacking. OBJECTIVE: The aim of this study was to identify the most effective method to reduce hypophonia. METHODS: In this randomized controlled trial, 44 PwMS were randomized to intensive and high-effort voice treatment groups, the LSVT-LOUD®, and conventional treatment group. Subjects received 16 treatments (4 sessions/week) lasting 45 minutes. The primary outcome was voice intensity (dB) in monologue, vocalization, and sentences while voice handicap index (VHI) measured voice self-perception. Outcomes were assessed by a blinded observer at baseline, post-treatment, and 15-month follow-up (FU). RESULTS: Linear models revealed a significant post-intervention between-group mean difference in favor of LSVT-LOUD for monologue: +6.3 dB (95% CI: 2.5 to 10.1); vocalization: +7.4 dB (95% CI: 2.3 to 12.5); and sentences: +9.5 dB (95% CI: 4.7 to 14.3). However, 43.7% PwMS in the LSVT-LOUD and 10% in the conventional treatment group obtained a full recovery of voice intensity (>60 dB) post-treatment, Fisher's test = 13.3, p < 0.01. However, these improvements were not maintained at FU. Between-group differences at VHI were -10.8 (95% CI: -21.2 to -0.4) and -11.3 (95% CI: -24.3 to -1.7) in favor of LSVT-LOUD at post and FU. CONCLUSION: LSVT-LOUD can be a valid treatment to increase voice intensity in PwMS. However, results suggest the need for FU interventions targeting maintenance.

Effect of Impairment-Oriented and Function-Oriented Exercises on Mouth Function in Subjects with Systemic Sclerosis.

PURPOSE: The aim of this study was to develop an exercise protocol to improve maximal mouth opening (MMO), tongue protrusion (Tprot), tongue strength (Tstren), and lip strength (Lstren), and to assess its effects on subjects with scleroderma. METHODS: We performed four replicated single-system studies in a consecutive sample of subjects with scleroderma. An instrumented assessment measured MMO, Tprot, Tstren, and Lstren. Each day, subjects were assessed and performed orofacial exercises conducted by speech therapists. Treatments were first aimed at improving mouth physical characteristics by impairment-oriented exercises and then to improve skills with function-oriented exercises. RESULTS: The mean phase differences between assessment and treatment phases across subjects were from 0.88 to 9.56 mm in MMO, from 2.03 to 12.3 mm in Tprot, from -0.12 to 5.35 N in Tstren, and from -0.84 to 5.19 N in Lstren. After treatment, 3 subjects crossed the 5th percentile discriminating normal from abnormal performances for both Tstren and Tprot, while this occurred in 2 subjects for MMO and Lstren. CONCLUSIONS: The results of this study suggest that rehabilitation appears to be useful in reducing tongue and lip impairments and in improving oral functions in subjects with scleroderma.

Instrumented Assessment of Oral Motor Function in Healthy Subjects and People with Systemic Sclerosis.

The aim of the present study was to provide quantitative data of oral function in healthy subjects (HSs), validity of measurements and estimation of measurement bias, as well as quantify oral impairment in persons with scleroderma (SSc). 151 HSs and 12 subjects with SSc were recruited and assessed using instrumented tools, measuring maximal mouth opening; lip strength; and tongue strength, protrusion, retraction, and endurance. Twenty HSs were also retested 3-5 weeks later in order to assess the test-retest reliability of the measurements. Intraclass correlation coefficients proved to be satisfactory (>0.8) for both inter-rater and test-retest reliabilities of all measurements except for tongue retraction. In the HS group, maximal mouth opening and tongue and lips strength values were larger (P < 0.05) for males than females, while no significant differences were found for other variables. Older subjects had statistically significantly lower tongue retraction values and tongue endurance values than younger subjects. The SSc group showed a statistically significant decrease (P < 0.05) in almost all the measurements. Assessment procedures proved to be valid and reliable. Gender and height were predictors of mouth opening, lip and tongue strength, while age correlates with tongue retraction and endurance. Measurements highlighted the strong impact of SSc on oral functions and in particular on tongue protrusion, tongue strength, and endurance.

Oropharyngolaryngeal disorders in scleroderma: development and validation of the SLS scale.

Systemic sclerosis (SSc) is a multisystemic disorder characterized by functional and structural abnormalities of small blood vessels and fibrosis of the skin and internal organs. Eighty percent of subjects with SSc have orofacial manifestations. No tests for oral manifestations have been validated for this pathology, and in the literature there are few studies of speech therapy for subjects with SSc. These facts suggested the need for an exhaustive assessment of mouth mobility and muscle strength, and also of swallowing and voice, in order to plan a targeted and effective speech therapy. The Scleroderma Logopedic Scale (SLS) has been developed to assess disorders in five domains: Impairment, Swallow, Voice, Multifield, and Quality of Life. Perception of these disorders was assessed in 84 subjects with SSc and in 40 healthy subjects. After the first draft, a shorter form (39 items) was obtained after statistical analysis. This scale showed good discriminant and concurrent validity. Internal consistency was good: three of five subscales had a Cronbach alpha coefficient higher than 0.8. The test/retest coefficient for the total score was 0.94. Thirty-six percent of examined subjects showed moderate to severe oropharyngolaryngeal disorders. Swallowing disorders and impairment of mouth (e.g., decrease in mobility and strength) were the most commonly reported problems. Conversely, the change of voice due to the pathology was not perceived as a problem. Fifty-five percent of subjects reported a decreased level of quality of life.