Parkinson Disease
Conditions
Keywords
Speech therapy, Telerehabilitation, Quality of life
Brief summary
Background: Up to 70% of the patients with Parkinson's Disease (PD) experience speech problems, which cause a diminished intelligibility. A reduced intelligibility has a profound negative impact on social interaction and quality of life. Since pharmacological treatment only has limited effects on speech, non-pharmacological treatment, like speech therapy, is particularly relevant. Cochrane reviews (Herd et al., 2012a; Herd et al., 2012b) showed that evidence for speech therapy in PD is increasing, but is still inconclusive. Moreover, only very intensive standardized treatment programs have been studied, which are only feasible for people with mild to moderate PD, but too intensive for people with advanced PD. Here, the investigators will perform the first large-scale study to demonstrate the efficacy of speech therapy in PD patients in all disease stages on quality of life and speech quality. Objective: The aim is to demonstrate the effectiveness of personalized and home-based speech therapy on quality of life, intelligibility and social participation for people with Parkinson's disease who have a reduced intelligibility of speech. Methods: The investigators will perform a single blind, randomized and controlled trial. A total of 215 patients (18 years and older) with PD in all disease stages who have difficulty with intelligibility affecting daily communication will participate in this study. The patients will be randomly allocated to either speech therapy or a waiting list control group (1:1 ratio). Speech therapy using telerehabilitation will be provided for 8 weeks which consists of 12-16 sessions. The control group will receive deferred treatment after 8 weeks. The measurements will take place before the randomization (To), after 8 weeks (T1), and for the experimental group also after 24 weeks (T2). The primary outcome measure is quality of life, as measured using the total score on the PDQ-39. Secondary outcome measures include speech and voice, speech intelligibility, non-motor symptoms and caregiver burden. Hypothesis: The investigators hypothesize that patients in all disease stages can improve their speech intelligibility by using the explicit feedback from external cues provided by instructed caregivers plus a dedicated smartphone/ tablet app (the Voice Trainer app).
Interventions
OTHERSpeech therapy
Online speech therapy, delivered by specialized speech therapists. Speech therapy will be complemented by a real-time visual feedback app (the Voice Trainer app).
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessors will be blinded for treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of idiopathic PD; * Problems in intelligibility affecting daily communication (as indicated by the patient and/or the caregiver); * A desire for improvement; * willing and able to receive online treatment
Exclusion criteria
* Recent (\<1 year) speech therapy; * Voice or speech problems due to other causes; * Communication difficulties based on language problems without predominantly reduced intelligibility; * inability to receive online treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-specific health-related quality of life | Baseline (T0), primary endpoint after 8 weeks (T1) | Parkinson's Disease Questionnaire (PDQ-39) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech quality | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Radboud Dysarthria Assessment (RDA) |
| Voice quality | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Acoustic Voice Quality Index (AVQI) |
| Voice handicap | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Voice Handicap Index (VHI) |
| Severity of voice and speech complaints, reported by patient | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Radboud Oral Motor inventory for Parkinson's disease (ROMP) |
| Severity of voice and speech complaints, reported by caregiver | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Radboud Oral Motor inventory for Parkinson's disease (ROMP), adapted to caregiver |
| Caregiver burden | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Zarit caregiver Burden Interview Short Form (ZBI-12) |
| Mood and anxiety | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2). Minimum score = 0 (no anxiety or depression), maximum score = 42 (most anxiety or depression). | Hospital Anxiety and Depression Scale (HADS) |
| Health-related quality of life | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | EuroQol-5D (EQ-5D) |
| Swallowing | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Maximum swallowing speed (timed test) |
| Speech intelligibility | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Dutch intelligibility test - sentence level (NSVO-Z) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease-specific health-related quality of life (follow-up) | Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | Parkinson's Disease Questionnaire (PDQ-39) |
Countries
Netherlands
Outcome results
None listed