Atlas University
Kâğıthane, Istanbul, 34403, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07730073
Parkinson's disease often causes speech and voice impairments, such as reduced vocal loudness and decreased speech intelligibility, which significantly impact the quality of life for patients and their families. The Lee Silverman Voice Therapy-LOUD (LSVT-LOUD) is a specialized, evidence-based speech therapy protocol designed to improve vocal function.
This study investigates the effectiveness of the LSVT-LOUD protocol in Turkish-speaking individuals with Parkinson's disease. The research evaluates objective changes in vocal loudness and speech quality, as well as the subjective therapy experiences of participants. By analyzing both clinical outcomes and patient feedback, this study aims to contribute to the clinical application and adaptation of LSVT-LOUD for the Turkish-speaking population
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
Kâğıthane, Istanbul, 34403, Turkey (Türkiye)
Location status: Recruiting
This study implements the standardized Lee Silverman Voice Treatment (LSVT-LOUD) protocol, an intensive intervention focused on the recalibration of vocal effort through motor learning principles. The intervention requires participants to attend individual therapy sessions conducted four times per week over a four-week period, with each session lasting 60 minutes.
The protocol emphasizes high-effort phonation and is structured into the following components:
Daily Tasks: Sustained vowel phonation (maximum duration and stability), pitch range exercises (high-to-low and low-to-high glides), and maximum functional loudness drills using high-effort speech.
Hierarchy Tasks: Systematic progression from word-level to sentence-level and, finally, conversational speech tasks, incorporating high-effort vocal production into increasingly complex linguistic structures.
Carry-over Exercises: Daily practice assignments designed to facilitate the generalization of high-effort speech into activities of daily living and social interactions.
Clinical instruction emphasizes the patient's sensory perception of vocal effort, using acoustic feedback to help participants recalibrate their internal perception of 'loud' versus 'normal' speech. The protocol is conducted in Turkish, adhering to the original LSVT-LOUD methodological requirements while accounting for linguistic nuances of the Turkish language.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnosis: Patients with a confirmed diagnosis of Idiopathic Parkinson's Disease (Hoehn and Yahr stages I-III).
Age: Individuals aged 40-80 years.
Language: Native Turkish speakers.
Cognitive Status: Sufficient cognitive function to participate in therapy (e.g., Mini-Mental State Examination (MMSE) score ≥ 24).
Communication: Presence of voice or speech impairment (e.g., hypophonia, reduced intelligibility) as confirmed by a speech-language pathologist.
Stability: Stable medication regimen for at least 1 month prior to the study initiation.
Exclusion criteria
Neurological Comorbidities: Presence of other significant neurological disorders (e.g., stroke, traumatic brain injury, multiple sclerosis) or active voice disorders (e.g., vocal cord nodules, laryngeal cancer).
Hearing Impairment: Uncorrected hearing loss that would interfere with speech assessment or therapy.
Cognitive Impairment: Diagnosis of dementia or severe cognitive impairment that prevents participation in the intensive LSVT-LOUD protocol.
Recent Surgery: History of laryngeal surgery or deep brain stimulation (DBS) within the last 6 months.
Therapy History: Previous experience with LSVT-LOUD or intensive speech therapy within the past year.
The LSVT-LOUD protocol is a structured, intensive speech treatment specifically designed for individuals with Parkinson's disease. The intervention follows a standardized format: 4 individual 60-minute sessions per week for 4 consecutive weeks (total of 16 sessions).
The core exercises include:
Daily Tasks: Sustained phonation (holding 'ah' at a loud, stable pitch), pitch range exercises (high and low), and maximum duration of vowel phonation.
Functional Speech Tasks: Practicing high-effort vocalization using functional phrases, sentences, and hierarchical reading/conversation tasks in clinical sessions.
Carryover Exercises: Daily homework and 'real-world' assignments to facilitate the generalization of increased vocal loudness and speech quality into everyday life.
The therapy emphasizes high-effort motor output, sensory recalibration (helping the patient perceive their 'loud' voice as normal), and intensive repetition to maximize neuroplasticity and therapeutic outcomes.
Time frame: Post-therapy (4 weeks)
Semi-structured interview form conducted with participants and their primary caregivers to explore subjective therapy experiences, including motivation, challenges, perceived benefits, and communication improvements. Analysis performed using thematic analysis methods.
Time frame: Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.
Measured through acoustic analysis of sustained phonation and standardized speech tasks to evaluate changes in vocal intensity. - Decibels (dB)
Time frame: Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.
Evaluation of vocal stability by measuring cycle-to-cycle variability in fundamental frequency (Jitter) and amplitude (Shimmer) during sustained vowel phonation. - Unit of Measure: Percentage (%)
Time frame: Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.
Mean fundamental frequency of the voice during sustained phonation. - Hertz (Hz)
Time frame: Post-therapy (4 weeks)
Total score of the Voice Handicap Index (VHI) to assess the impact of voice problems on quality of life. - Score (Scale: 0-43)
Time frame: post-therapy (4 weeks)
Assessment of Parkinson's disease-specific health-related quality of life using the Parkinson's Disease Questionnaire (PDQ-39). The questionnaire evaluates several domains including mobility, activities of daily living, emotional well-being, and communication. Unit of Measure: Score (Scale: 0-156)
Contact information is provided by the study sponsor or research team.
Atlas University
Other
The Effect of Lee Silverman Voice Therapy-LOUD (LVST-LOUD) Therapy Method on Voice and Speech Skills and Examination of Therapy Experiences in Turkish-Speaking Individuals With Parkinson's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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