Skip to main content
OpenTrials
Completed

NCT Number: NCT03963388

PERsonalized SPEeCh Therapy for actIVE Conversation

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).

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speech therapy

Other

Online speech therapy, delivered by specialized speech therapists. Speech therapy will be complemented by a real-time visual feedback app (the Voice Trainer app).

Primary outcomes

  1. Disease-specific health-related quality of life

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1)

    Parkinson's Disease Questionnaire (PDQ-39)

Secondary outcomes

  1. Speech quality

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Radboud Dysarthria Assessment (RDA)

  2. Voice quality

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Acoustic Voice Quality Index (AVQI)

  3. Voice handicap

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Voice Handicap Index (VHI)

  4. Severity of voice and speech complaints, reported by patient

    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)

  5. Severity of voice and speech complaints, reported by caregiver

    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

  6. Speech intelligibility

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Dutch intelligibility test - sentence level (NSVO-Z)

  7. Caregiver burden

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Zarit caregiver Burden Interview Short Form (ZBI-12)

  8. Mood and anxiety

    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)

  9. Health-related quality of life

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    EuroQol-5D (EQ-5D)

  10. Swallowing

    Time frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Maximum swallowing speed (timed test)

Other outcomes

  1. Disease-specific health-related quality of life (follow-up)

    Time frame: Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

    Parkinson's Disease Questionnaire (PDQ-39)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

The PERSPECTIVE Study: PERsonalized SPEeCh Therapy for actIVE Conversation

Acronym: PERSPECTIVE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 24, 2019
Registry last updated
May 30, 2023

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.