PERsonalized SPEeCh Therapy for actIVE Conversation

Parkinson Disease Clinical Trial

— PERSPECTIVE  

Official title:

The PERSPECTIVE Study: PERsonalized SPEeCh Therapy for actIVE Conversation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963388
• Other study ID #: NL67867.091.18
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 10, 2021

Study information

• Verified date: May 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication Disorders
• Parkinson Disease

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease-specific health-related quality of life (follow-up)	Parkinson's Disease Questionnaire (PDQ-39)	Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Primary	Disease-specific health-related quality of life	Parkinson's Disease Questionnaire (PDQ-39)	Baseline (T0), primary endpoint after 8 weeks (T1)
Secondary	Speech quality	Radboud Dysarthria Assessment (RDA)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Voice quality	Acoustic Voice Quality Index (AVQI)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Voice handicap	Voice Handicap Index (VHI)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Severity of voice and speech complaints, reported by patient	Radboud Oral Motor inventory for Parkinson's disease (ROMP)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Severity of voice and speech complaints, reported by caregiver	Radboud Oral Motor inventory for Parkinson's disease (ROMP), adapted to caregiver	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Speech intelligibility	Dutch intelligibility test - sentence level (NSVO-Z)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Caregiver burden	Zarit caregiver Burden Interview Short Form (ZBI-12)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Mood and anxiety	Hospital Anxiety and Depression Scale (HADS)	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).
Secondary	Health-related quality of life	EuroQol-5D (EQ-5D)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Secondary	Swallowing	Maximum swallowing speed (timed test)	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)