None listed
Conditions
Brief summary
Communication, swallowing and cough function problems are common clinical features among individuals with Parkinson’s, which negatively affect the quality of life and increase morbidity and mortality. Lee Silverman Voice Treatment (LSVT LOUD) is a standardized voice therapy which has system-wide effects on voice, communication, swallowing and cough function according to the recent pilot studies. We hypothesized LSVT LOUD programme which activates neuromuscular control of the entire aerodigestive tract would have a positive impact on both swallowing and cough function based on the improved measures from previous pilot studies. Aim of the study is to evaluate the spread effects of LSVT LOUD on swallowing and cough functions in individuals with Parkinson’s. Methodology The study will include intervention group - Parkinson’s group who will receive intervention and one Parkinson’s control group who will not receive the intervention. Values of Age-matched healthy control group from existing data base of the University lab will be obtained to compare the findings with normative values. All participants included in the study will be assessed at 5-time points, followed up for 2 years. LSVT LOUD interventional programme will be administered to the intervention group as per the set protocol in 16 sessions across four weeks. 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. Necessary descriptive and inferential analysis of the measures will be done to address the study objectives.
Interventions
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 sel
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.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed