Efficacy of LSVT-LOUD Therapy on Voice, Speech, and Quality of Life in Parkinson's Disease

NCT07730073 | Recruiting

• 1 other identifier: 61351342/020-220
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease (PD)

Outcome Measures

Primary Outcomes (4)

• Qualitative Therapy Experience

  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.

  Post-therapy (4 weeks)

• Vocal Intensity (Loudness)

  Measured through acoustic analysis of sustained phonation and standardized speech tasks to evaluate changes in vocal intensity. - Decibels (dB)

  Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.

• Acoustic Voice Stability (Jitter and Shimmer)

  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 (%)

  Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.

• Fundamental Frequency (F0)

  Mean fundamental frequency of the voice during sustained phonation. - Hertz (Hz)

  Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.

Secondary Outcomes (2)

• Voice Handicap Index (VHI)

  Post-therapy (4 weeks)

• Parkinson's Disease Questionnaire (PDQ-39)

  post-therapy (4 weeks)

Study Arms (2)

LSVT-LOUD Therapy Group

EXPERIMENTAL

"Participants in this arm receive the standard Lee Silverman Voice Therapy (LSVT-LOUD) protocol. The intervention consists of intensive, high-effort vocal exercises designed to increase vocal loudness and improve speech intelligibility. The protocol is administered in 4 sessions per week, with each session lasting 60 minutes, over a total duration of 4 weeks. The therapy focuses on maximizing vocal output through calibrated exercises, including sustained phonation, pitch range exercises, and functional speech tasks. Additionally, participants are provided with carryover exercises to practice at home to ensure long-term maintenance of improved vocal and speech functions .

Behavioral: LSVT-LOUD Therapy

Control Group

NO INTERVENTION

Participants in the control group receive standard medical care for Parkinson's disease, with no specific intensive speech therapy intervention provided during the study period

Interventions

LSVT-LOUD Therapy BEHAVIORAL

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.

LSVT-LOUD Therapy Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas University

Kâğıthane, Istanbul, 34403, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ayşe Nur Koçak, Master of Science

CONTACT

+90 549 650 20 60; aysenur.kocak@atlas.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 28, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: pon publication of the thesis and related manuscripts
• Access Criteria: Access to individual participant data (IPD) and supporting documentation (study protocol, statistical analysis plan, and clinical study report) is provided to qualified researchers, academic institutions, and clinicians who demonstrate a legitimate scientific interest and a methodologically sound research proposal.

Locations

TU (1)