Radboud university medical center
Nijmegen, Gelderland, 6500HB, Netherlands
NCT Number: NCT03963388
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Nijmegen, Gelderland, 6500HB, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Online speech therapy, delivered by specialized speech therapists. Speech therapy will be complemented by a real-time visual feedback app (the Voice Trainer app).
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1)
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Radboud Dysarthria Assessment (RDA)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Acoustic Voice Quality Index (AVQI)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Voice Handicap Index (VHI)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
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)
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)
Dutch intelligibility test - sentence level (NSVO-Z)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Zarit caregiver Burden Interview Short Form (ZBI-12)
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).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
EuroQol-5D (EQ-5D)
Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Maximum swallowing speed (timed test)
Time frame: Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Parkinson's Disease Questionnaire (PDQ-39)
Radboud University Medical Center
Other
The PERSPECTIVE Study: PERsonalized SPEeCh Therapy for actIVE Conversation
Acronym: PERSPECTIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02973698
Basal Ganglia Diseases, Behavior
View Trial DetailsNCT06133283
Basal Ganglia Diseases, Brain Diseases
San Antonio, Texas, United States
View Trial DetailsNCT05766813
Basal Ganglia Diseases, Brain Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT07723027
Basal Ganglia Diseases, Brain Diseases
Shakargarh, Punjab Province, Pakistan
View Trial Details