Clinical trial NCT03963388: PERsonalized SPEeCh Therapy for actIVE Conversation
Official title: The PERSPECTIVE Study: PERsonalized SPEeCh Therapy for actIVE Conversation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Speech therapy
Telerehabilitation
Quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2019-05-24
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Disease-specific health-related quality of life
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1)
Secondary outcomes:
measure: Speech quality
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Voice quality
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Voice handicap
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Severity of voice and speech complaints, reported by patient
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Severity of voice and speech complaints, reported by caregiver
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Speech intelligibility
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Caregiver burden
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Mood and anxiety
timeFrame: 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).
measure: Health-related quality of life
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
measure: Swallowing
timeFrame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Other outcomes:
measure: Disease-specific health-related quality of life (follow-up)
timeFrame: Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Department of Neurology, Radboudumc, Nijmegen, the Netherlands
name: Bastiaan R Bloem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herd CP, Tomlinson CL, Deane KH, Brady MC, Smith CH, Sackley CM, Clarke CE. Speech and language therapy versus placebo or no intervention for speech problems in Parkinson's disease. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD002812. doi: 10.1002/14651858.CD002812.pub2.
citation: Herd CP, Tomlinson CL, Deane KH, Brady MC, Smith CH, Sackley CM, Clarke CE. Comparison of speech and language therapy techniques for speech problems in Parkinson's disease. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD002814. doi: 10.1002/14651858.CD002814.pub2.
citation: Maas JJL, De Vries NM, Bloem BR, Kalf JG. Design of the PERSPECTIVE study: PERsonalized SPEeCh Therapy for actIVE conversation in Parkinson's disease (randomized controlled trial). Trials. 2022 Apr 8;23(1):274. doi: 10.1186/s13063-022-06160-9.