An interventional study of Speech therapy in Parkinson Disease, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-30.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 214 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Speech therapy, right after T0 (baseline measurement).
Other: Speech therapy
Patients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech 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).
Disease-specific health-related quality of life
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1)
Speech quality
Radboud Dysarthria Assessment (RDA)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Voice quality
Acoustic Voice Quality Index (AVQI)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Voice handicap
Voice Handicap Index (VHI)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Severity of voice and speech complaints, reported by patient
Radboud Oral Motor inventory for Parkinson's disease (ROMP)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Severity of voice and speech complaints, reported by caregiver
Radboud Oral Motor inventory for Parkinson's disease (ROMP), adapted to caregiver
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Speech intelligibility
Dutch intelligibility test - sentence level (NSVO-Z)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Caregiver burden
Zarit caregiver Burden Interview Short Form (ZBI-12)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Mood and anxiety
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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).
Health-related quality of life
EuroQol-5D (EQ-5D)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Swallowing
Maximum swallowing speed (timed test)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Disease-specific health-related quality of life (follow-up)
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Plan to share: Yes — We will make relevant and anonymised data available in a validated database (DANS Easy).
Supporting information: Study protocol, Sap
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center