Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming months in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12613001088730
Ethics application status
Not yet submitted
Date submitted
20/09/2013
Date registered
27/09/2013
Date last updated
27/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Lee Silverman Voice Treatment on swallowing in Parkinson's Disease
Scientific title
A non randomized videofluoroscopic swallowing study assessment of the effect of Lee Silverman Voice Treatment on swallowing in Parkinson's Disease patients.
Secondary ID [1] 283240 0
Nil known
Secondary ID [2] 283267 0
nil
Universal Trial Number (UTN)
U1111-1148-0338
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 290107 0
Deglutition 290108 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290486 290486 0 0
Speech therapy
Neurological 290487 290487 0 0
Parkinson's disease
Oral and Gastrointestinal 290488 290488 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients receiving Lee Silverman Voice Therapy will be studied with pre-treatment and post-treatment videofluoroscopic swallowing studies to assess effect on swallowing. Exposure is three videofluoroscopic swallowing studies at time 0, one week post therapy and six months post therapy
Lee Silverman Voice Therapy will be conducted as per standardized protocol.
*Criteria for Lee Silverman Voice Therapy
a) Motivated and able to commit to intensive therapy
b) Adequate hearing
c) Adequate cognition and memory
d) Able to access a community clinic close to their home
e) Positive results on stimulability testing suggesting likely response to treatment (is the patient able to improve loudness and quality? Can they achieve sustained vowel phonation, high and low pitch slide on ‘ah’ and functional phrases?)
f) Socially active and keen to increase participation
g) ORL assessment indicates that there are no contraindications for intensive voice treatment
*Measures recorded for Lee Silverman Voice Therapy
a) Average dB duration ‘ah’ (sustained phonation)
b) Average length of maximum duration ‘ah’
c) Average dB of functional phrases
d) Average dB of conversational speech
e) Complete Voice Handicap Index pre- and post-therapy
Subjects then undergo Lee Silverman Voice Treatment (registered trademark) consisting of 2 assessment sessions and 16 treatment sessions over six weeks (three sessions per week). At each session the subject participates in instructed vocal exercises consisting of prolonged vowel phonation with increasing volumes, functional words and phrases with increasing volumes, measured and modified by a sound meter. Biofeedback is provided during sessions by listening to recorded personal phonation and subjects rate their own voice. Sessions are approximately 45 minutes long.
This is a designated treatment regimen for voice problems in Parkinson's Disease. No deviations are permitted.
VFS studies are approximately 10-15 minutes in length.
LSVT is administered as a single block of treatment. This will occur once over 3 weeks. VFSS will be performed on three occasions ie. pre-therapy, one week post completion of therapy and six months post completion of therapy.
Intervention code [1] 287965 0
Other interventions
Intervention code [2] 288015 0
Treatment: Other
Comparator / control treatment
No therapy, Parkinson's Disease patients that have not received Lee Silverman Voice Treatment and normal elderly swallowing data. Normative data is available from published sources. Historical swallow studies from patients with Parkinson's Disease will be evaluated from a database at Waitemata District Healthboard. Studies performed between 2010-2012 will be reviewed. During this time period a standard VFSS protocol was used but no patients received LSVT.
Control group
Historical

Outcomes
Primary outcome [1] 290509 0
Objective measures of swallowing from Videofluoroscopic swallowing studies. This is a composite outcome as all measures are evaluated for each single study. The measures will be compared between time points. Measures made are Maximal opening of the pharyngoesophageal segment; pharyngeal constriction ratio; pharyngeal transit time; penetration; aspiration; hyolaryngeal elevation.
Timepoint [1] 290509 0
Pre-treatment (within one month before initiating LSVT), one week post-treatment and six months post treatment
Secondary outcome [1] 304781 0
Self-report swallowing quality of life as per the Eating Assessment Tool-10 survey
Timepoint [1] 304781 0
Pretreatment (within one month before initiating LSVT), one week post therapy, six months post therapy

Eligibility
Key inclusion criteria
1) Parkinson’s Disease patients with voice dysfunction desiring voice therapy and meeting inclusion criteria for Lee Silverman Voice Treatment [registered trademark] (*see below)
2) Ability to attend 18 sessions of therapy and three swallowing assessments (VFSS)
3) Ability to complete self assessment questionnaires (Eating Assessment Tool-10) by oral report or written completion

*Criteria for Lee Silverman Voice Therapy
a) Motivated and able to commit to intensive therapy
b) Adequate hearing
c) Adequate cognition and memory
d) Able to access a community clinic close to their home
e) Positive results on stimulability testing suggesting likely response to treatment (is the patient able to improve loudness and quality? Can they achieve sustained vowel phonation, high and low pitch slide on ‘ah’ and functional phrases?)
f) Socially active and keen to increase participation
g) ORL assessment indicates that there are no contraindications for intensive voice treatment
*Measures recorded for Lee Silverman Voice Therapy
a) Average dB duration ‘ah’ (sustained phonation)
b) Average length of maximum duration ‘ah’
c) Average dB of functional phrases
d) Average dB of conversational speech
e) Complete Voice Handicap Index pre- and post-therapy
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
1) Parkinson’s Disease without voice dysfunction
2) Do not meet criteria for Lee Silverman Voice Therapy
3) Inability to attend full course of therapy or follow up reviews and swallow studies
4) Vocal pathology requiring alternative treatment eg. Surgery
5) Previous LSVT training
6) Previous history of head and neck radiotherapy treatment
7) Co morbidity affecting swallowing ability eg. Cerebrovascular accident, neurogenic dysphagia of other aetiology, post-surgical dysphagia, infective dysphagia or dementia
8) Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus
9) Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 45 years of age). Unlikely to be any subjects that meet this criteria.
10) Non oral feeding for primary nutrition
11) Active tumour involving the larynx or oesophagus
12) Allergic reaction to barium contrast agent
13) Patients with a current, at the time of evaluation, and/or history of Zenker’s diverticulum.
14) Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
15) Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy (will not qualify for LSVT).
16) Patients under palliative care.
17) Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.


Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting to WDHB with Parkinson’s Disease and vocal deterioration that meet the inclusion criteria for Lee Silverman Voice Treatment will be invited to participate in the study. After written consent is obtained all enrolled subjects will undergo a videofluoroscopic swallow study prior to commencing LSVT. Patients will also complete a validated, self-assessment questionnaire regarding their swallow ability, the Eating Assessment Tool-10 (EAT-10) before and after LSVT. At one week and six months following completion of LSVT subjects will complete a further VFSS and EAT-10 questionnaire. Enrollment will occur by face-to-face invitation from patients referred to the Speech Language Therapy department at North Shore Hospital for voice therapy to assist Parkinson's hypophonia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomized. Sequential recruitment of first 20 eligible subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
The principle investigator and co investigator will not perform LSVT and will be blinded to when the VFSS has been performed. Data analysis is via a standardized quantitative protocol from recorded studies.
All swallow studies will be reviewed independently in a blinded fashion. Studies will be de-identified and presented in random order to the assessing clinicians. Studies will be classified according to the PAS developed by Rosenbek et al. The PAS defines penetration as material entering the airway but not passing below the vocal folds. Aspiration is defined as material below the level of the vocal folds. The scale further delineates grading by depth of penetration or aspiration, and by patient response to the event. Swallow studies will also be measured quantitatively using parameters derived from the protocol published by Leonard and Kendall.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Mean UES opening, swallowing safety (PAS), and EAT-10 scores will be compared before and after LSVT by analysis of variance, treating examiner as a fixed effect and patient as a random effect to account for repeated measures. All tests will be two-sided; tests will be at a level 0.05, with Bonferroni correction for multiple comparison. Quality of life with the EAT-10 will be assessed at baseline, 1 week after LSVT completion and 6 months after LSVT completion.
Power calculation has been completed. Twenty patients will be recruited. To detect a change of more than two standard deviations in swallowing ability with 80% power and setting a=0.05, would require 13 subjects. This allows for drop out or loss to follow up in the cohort.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5433 0
New Zealand
State/province [1] 5433 0

Funding & Sponsors
Funding source category [1] 288006 0
Hospital
Name [1] 288006 0
North Shore Hospital,
Waitemata District Health Board
Address [1] 288006 0
Shakespeare Rd
Takapuna
Auckland 0622
Country [1] 288006 0
New Zealand
Primary sponsor type
Individual
Name
Jacqueline Allen
Address
Otolaryngology Department
North Shore Hospital
Shakespeare Rd
Takapuna
Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 286728 0
Hospital
Name [1] 286728 0
North Shore Hospital,
Waitemata District Health Board
Address [1] 286728 0
Shakespeare Rd
Takapuna
Auckland 0622
Country [1] 286728 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289930 0
Northern X Ethics Committee
Ethics committee address [1] 289930 0
C/o Medsafe , Level 6
Deloitte House
10 Brandon St
Wellington 6011
Ethics committee country [1] 289930 0
New Zealand
Date submitted for ethics approval [1] 289930 0
30/09/2013
Approval date [1] 289930 0
Ethics approval number [1] 289930 0

Summary
Brief summary
This study will assess the effect on swallowing of a well-known voice therapy treatment (Lee Silverman Voice Treatment) for patients with Parkinson's Disease. Those who are having Voice therapy to help improve speech will be invited to have their swallowing assessed before and after the therapy has taken place. We believe the therapy will also improve swallowing, as it does speech, and we intend to measure the improvement by analyzing barium contrast swallow studies performed before and after the therapy is done.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43030 0
Dr Jacqueline Allen
Address 43030 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149

Waitemata District Health Board
Shakespeare Rd
Takapuna
Auckland 0622
Country 43030 0
New Zealand
Phone 43030 0
+6421897444
Fax 43030 0
+6496311966
Email 43030 0
jeallen@voiceandswallow.co.nz
Contact person for public queries
Name 43031 0
Dr Jacqueline Allen
Address 43031 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 43031 0
New Zealand
Phone 43031 0
+6421897444
Fax 43031 0
Email 43031 0
jeallen@voiceandswallow.co.nz
Contact person for scientific queries
Name 43032 0
Dr Jacqueline Allen
Address 43032 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 43032 0
New Zealand
Phone 43032 0
+6421897444
Fax 43032 0
Email 43032 0
jeallen@voiceandswallow.co.nz