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Trial registered on ANZCTR


Registration number
ACTRN12619001146189
Ethics application status
Approved
Date submitted
22/07/2019
Date registered
16/08/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
16/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Lee Silverman Voice Treatment (LSVT LOUD) on voice, swallowing and cough function in Parkinson’s Disease: A randomized controlled trial
Scientific title
Effectiveness of Lee Silverman Voice Treatment (LSVT LOUD) on voice, swallowing and cough function in Parkinson’s Disease: A randomized controlled trial
Secondary ID [1] 298780 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 313737 0
Condition category
Condition code
Neurological 312140 312140 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 312288 312288 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Procedures
The study will be a prospective randomized controlled interventional study.
Three groups will participate in this study, two Parkinson’s groups that will receive intervention (based on post hoc severity grading on swallow dysfunction ; EAT score more than 3 vs EAT score 3 or less) and one Parkinson’s control group that will not receive the intervention. According to the sample size calculation, 37 participants for each group will be included. Age-matched healthy controls will be selected for normative values from the University of Auckland database.
All participants included in the study will be assessed at 5-time points (1-week pre-treatment, 1-week post-treatment, 6-months post-treatment, 1 year post-treatment and two years post-treatment), followed up for 2 years.
Treatment
Lee Silverman Voice Treatment (LSVT LOUD) interventional programme will be administered to the intervention group as per the set protocol in 16 sessions across four weeks. At each session, patients need to participate in a series of vocal exercises during the treatment hour and daily assigned 10 minutes of home exercises. Treatment outcomes will be measured and assessed under the standard protocol. Biofeedback is provided during sessions by listening to recorded individual phonation and participants rate their own voice regularly throughout treatment.
LSVT LOUD treatment follows a standard protocol with intensive and high-effort speech exercises, has been validated and globally practiced voice therapy programme. https://www.lsvtglobal.com/LSVTLoud
Treatment fidelity will be assessed by investigators by stimulability testing (given in the treatment protocol) suggesting likely response to treatment (is the people able to improve loudness and quality? Can they achieve sustained vowel phonation, high and low pitch slide on ‘ah’ and functional phrases?.

Acoustic, voice, swallowing, cough, aerodynamic and laryngeal measures will be taken by standard instrumental assessment protocols. Patient-reported measures will be obtained by Self-rated questionnaires.
Who: Speech and language therapists with LSVT LOUD administering license will deliver the intervention.
Mode, intensity, and Dosage of therapy: Individual one-to-one treatment session of 1 hour, 4 consecutive days per week over a 4-week period
Location: Participants will complete therapy at the University of Auckland clinic.

Intervention code [1] 315055 0
Treatment: Other
Comparator / control treatment
The control group- will not receive LSVT LOUD treatment. They will represent the natural progression of speech, swallow and cough disorders in Parkinson's within the framework of scheduled trial speech therapy visits and medical treatment.
We chose not to use a sham treatment to adhere to the ethical principle of equipoise and to avoid placing undue time and effort burden on the untreated participants without the potential of therapeutic effect benefit.

Age- matched healthy control group- the study doesn't recruit any healthy participants but will include the values of healthy control group from existing data base of the University clinical Lab.
Control group
Active

Outcomes
Primary outcome [1] 320786 0
Speech and acoustic measures (composite outcome)-
Vocal loudness (task sustained vowel production and connected speech, measures will be obtained through sound level meter),
maximum phonation time (task sustained vowel production measured by seconds) , Harmonics to noise ratio (task sustained vowel production measured by visipitch software)
Timepoint [1] 320786 0
1-week pre-treatment (baseline), week 5 (1 week post-treatment completion), week 28 (6-months post-treatment completion), week 52 (1-year post-treatment completion) and week 100 (2 -years post-treatment completion).( primary end point)
Primary outcome [2] 320933 0
Objective swallow measures (composite primary outcome) - Task: swallow trials will be performed and will be obtained by videoflourosopic study report.
Timing measures (in seconds)
o Total pharyngeal transit time (TPT)
o Swallow gesture times (SGT)
o Pharyngoesophageal sphincter (PES) opening duration (PESdur)
o Maximum hyoid displacement duration (Hdur)
Displacement measures (cm)
o Maximum hyoid displacement (Hmax)
o Hyoid-larynx displacement (HLmax)
o Pharyngeal Constriction ratio (PCR)
o Maximal opening of the PES (PESmax)
Bolus constriction ratio (BCR)
Timepoint [2] 320933 0
1-week pre-treatment (baseline), week 5 (1 week post-treatment completion), week 52 (1-year post-treatment completion) and week 100 (2 -years post-treatment completion).( primary end point)
Primary outcome [3] 320934 0
Cough function and Aerodynamic measures (composite primary outcome)- task - voluntary and reflexive coughs, will be obtained using spirometric measures
Compression phase duration (CPD)
Peak expiratory flow rate (PEFR)
Peak expiratory flow rise time (PEFRT)
Cough volume acceleration (CVA)
Cough expired airflow volume (%)
Timepoint [3] 320934 0
1-week pre-treatment (baseline), week 5 (1 week post-treatment completion), week 28 (6-months post-treatment completion), week 52 (1-year post-treatment completion) and week 100 (2 -years post-treatment completion).( primary end point)
Secondary outcome [1] 372841 0
Patient-reported measures using,
1. Parkinson’s Disease Questionnaire-8 (PDQ-8)


Timepoint [1] 372841 0
1-week pre-treatment, 1-week post-treatment completion, 6-months post-treatment completion, 1-year post-treatment completion and 2 -years post-treatment completion.
Secondary outcome [2] 373388 0
Laryngostroboscopic measures (composite primary outcome)- Task- vowel i production, will be obtained by stroboscopic examination reports
Glottal configuration (GC).
Degree of glottal incompetence (GI)
Laryngeal hyperfunction rated for both false-fold compression (FF) and anterior-posterior (AP) compression.
Timepoint [2] 373388 0
1 week pre-treatment
Secondary outcome [3] 373389 0
High-resolution manometric measures (Composite primary outcome)- task : Swallow trials, measures will be obtained from manometry by reviewing spatio-temporal plots.
Mean minimum pressure (mmHg) during UES opening
Mean maximum closure and bolus clearance pressures at tongue base and velopharynx
Timepoint [3] 373389 0
1-week pre-treatment and, 1-year post-treatment completion
Secondary outcome [4] 373390 0
Patient reported measures using voice handicap index -10
Timepoint [4] 373390 0
1-week pre-treatment, 1-week post-treatment completion, 6-months post-treatment completion, 1-year post-treatment completion and 2 -years post-treatment completion.
Secondary outcome [5] 373391 0
patient reported measures through Eating Assessment Tool-10
Timepoint [5] 373391 0
1-week pre-treatment, 1-week post-treatment completion, 6-months post-treatment completion, 1-year post-treatment completion and 2 -years post-treatment completion.
Secondary outcome [6] 373392 0
patient reported measures through Hull Airway Reflux Questionnaire (HARQ)
Timepoint [6] 373392 0
1-week pre-treatment, 1-week post-treatment completion, 6-months post-treatment completion, 1-year post-treatment completion and 2 -years post-treatment completion.
Secondary outcome [7] 373393 0
patient reported measures through Communicative Effectiveness Index- Modified (CETI-M)
Timepoint [7] 373393 0
1-week pre-treatment, 1-week post-treatment completion, 6-months post-treatment completion, 1-year post-treatment completion and 2 -years post-treatment completion.

Eligibility
Key inclusion criteria
1) Individuals with PD who meet the inclusion criteria for LSVT LOUD (*see below).
2) Ability to attend the full programme (16 therapy session) and follow up reviews, swallow and cough studies.
3) Ability to complete self-reported questionnaires (PDQ-8, VHI-10, EAT-10, HARQ, and CETI-M) by written completion of the questionnaires or oral report. Carer support can be provided.
*Criteria for Lee Silverman Voice Therapy (LSVT LOUD)
a) Motivated and able to commit to intensive therapy
b) Adequate hearing
c) Adequate cognition and memory
d) Positive results on stimulability testing suggesting likely response to treatment (is the people able to improve loudness and quality? Can they achieve sustained vowel phonation, high and low pitch slide on ‘ah’ and functional phrases?)
e) Socially active and keen to increase participation
f) Otolaryngologist assessment reporting no contraindications to treatment.

Inclusion criteria for healthy control group
1) aged-matched healthy individuals
2) no history of neurological disorders
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) People with PD without voice dysfunction.
2) Diagnosis of atypical PD.
3) Speech or voice disorder unrelated to PD.
4) Vocal pathology requiring alternative treatment e.g. surgery
5) History of neurosurgical treatment.
6) History of laryngeal surgery or pathology.
7) Previous history of head and neck radiotherapy treatment
8) Co morbidity affecting swallowing ability eg. cerebrovascular accident, neurogenic dysphagia of other aetiology, post-surgical dysphagia, infective dysphagia or dementia, active tumour in larynx/ oesophagus, or Zenker’s diverticulum.
9) Currently pregnant, as evidenced by a positive result on a pregnancy test if the people are within child bearing age (younger than 45 years of age).
10) Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.
11) Swallowing problem requiring immediate attention.
12) Allergic reaction to the barium contrast agent.
13) People under palliative care.
14) History of speech treatment or LSVT LOUD in the last 2 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
two groups of Parkinson's disease will be receiving LSVT LOUD treatment and one group of Parkinson's disease will not receive LSVT LOUD treatment. The untreated group will represent the natural progression of difficulties in PD within the framework of scheduled trial visits and medical treatment.
age-matched healthy control group values will be included from previous university lab data base.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2019
Actual
15/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 21694 0
New Zealand
State/province [1] 21694 0
Auckland

Funding & Sponsors
Funding source category [1] 303337 0
University
Name [1] 303337 0
University of Auckland
Country [1] 303337 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Speech Science, School of Psychology, Faculty of Science, University of Auckland, Grafton Campus,
Building 507, 23-30 Park Avenue, Grafton 1023,
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 303373 0
None
Name [1] 303373 0
Address [1] 303373 0
Country [1] 303373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303866 0
HDEC, New Zealand
Ethics committee address [1] 303866 0
Ethics committee country [1] 303866 0
New Zealand
Date submitted for ethics approval [1] 303866 0
22/07/2019
Approval date [1] 303866 0
21/08/2019
Ethics approval number [1] 303866 0
19/CEN/131

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95074 0
Ms Fathima Shakeela
Address 95074 0
B072, Building 507, Grafton Campus, University of Auckland
22-30 Park Avenue,
Grafton, 1023
Auckland 1142
Country 95074 0
New Zealand
Phone 95074 0
+64 9 923 8177
Fax 95074 0
Email 95074 0
fabd416@aucklanduni.ac.nz
Contact person for public queries
Name 95075 0
Fathima Shakeela
Address 95075 0
B072, Building 507, Grafton Campus, University of Auckland
22-30 Park Avenue,
Grafton, 1023
Auckland 1142
Country 95075 0
New Zealand
Phone 95075 0
+64 9 923 8177
Fax 95075 0
Email 95075 0
fabd416@aucklanduni.ac.nz
Contact person for scientific queries
Name 95076 0
Anna Miles
Address 95076 0
507-2066, Building 507, Grafton Campus, University of Auckland
22-30 Park Avenue,
Grafton, 1023
Auckland 1142
Country 95076 0
New Zealand
Phone 95076 0
+64 9 923 8177
Fax 95076 0
Email 95076 0
a.miles@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.