Parkinson's Disease (PD)NCT07730073
Efficacy of LSVT-LOUD Therapy on Voice, Speech, and Quality of Life in Parkinson's Disease
A study testing LSVT-LOUD Therapy in people with Parkinson's Disease (PD), run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- LSVT-LOUD Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atlas University
Kâğıthane, Istanbul, 34403
Ayşe Nur Koçak, Master of Science, +90 549 650 20 60, aysenur.kocak@atlas.edu.tr
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- LSVT-LOUD Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSVT-LOUD TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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 (%)
Measured: 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)
Measured: Baseline (pre-therapy), post-therapy (4 weeks), 1-month follow-up, and 3-month follow-up.
Secondary outcomes (2)
Voice Handicap Index (VHI)
Total score of the Voice Handicap Index (VHI) to assess the impact of voice problems on quality of life. - Score (Scale: 0-43)
Measured: Post-therapy (4 weeks)
Parkinson's Disease Questionnaire (PDQ-39)
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)
Measured: post-therapy (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start18 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730073
- Sponsor's protocol ID
- 61351342/020-220
- Other IDs
- 61351342/020-220
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers who provide a methodologically sound proposal for secondary analysis. Data access will be granted for purposes approved by the study's ethics committee and in compliance with the principles of participant confidentiality and informed consent. Requests should be directed to the corresponding author via email, including a brief research protocol and a statement regarding the intended use of the data
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07730073
- Acronym / sponsor ID
- 61351342/020-220
- Conditions
- Parkinson's Disease (PD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSVT-LOUD Therapy Group | Experimental | Behavioral: LSVT-LOUD Therapy"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 . |
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSVT-LOUD TherapyThe 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. | Behavioural | LSVT-LOUD Therapy Group |
Primary outcome
Qualitative Therapy Experience
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.
Vocal Intensity (Loudness)
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)
Acoustic Voice Stability (Jitter and Shimmer)
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 (%)
Fundamental Frequency (F0)
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)
2 secondary outcomes
Voice Handicap Index (VHI)
Time frame: Post-therapy (4 weeks)
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: post-therapy (4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers who provide a methodologically sound proposal for secondary analysis. Data access will be granted for purposes approved by the study's ethics committee and in compliance with the principles of participant confidentiality and informed consent. Requests should be directed to the corresponding author via email, including a brief research protocol and a statement regarding the intended use of the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSVT-LOUD Therapy in people with Parkinson's Disease (PD), run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Nur Koçak, Master of Science (+90 549 650 20 60, aysenur.kocak@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Therapy Experience (time frame: Post-therapy (4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.