PERsonalized SPEeCh Therapy for actIVE Conversation (PERSPECTIVE)

May 26, 2023 updated by: Radboud University Medical Center

The PERSPECTIVE Study: 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Speech therapy, right after T0 (baseline measurement).
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).
No Intervention: Control group
Patients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific health-related quality of life
Time Frame: Baseline (T0), primary endpoint after 8 weeks (T1)
Parkinson's Disease Questionnaire (PDQ-39)
Baseline (T0), primary endpoint after 8 weeks (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech quality
Time Frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Radboud Dysarthria Assessment (RDA)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Voice quality
Time Frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Acoustic Voice Quality Index (AVQI)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Voice handicap
Time Frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Voice Handicap Index (VHI)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
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)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
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
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
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)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
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)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
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)
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
Time Frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
EuroQol-5D (EQ-5D)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Swallowing
Time Frame: Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)
Maximum swallowing speed (timed test)
Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Bastiaan R Bloem, MD, PhD, Department of Neurology, Radboudumc, Nijmegen, the Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

November 10, 2021

Study Completion (Actual)

November 10, 2021

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL67867.091.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will make relevant and anonymised data available in a validated database (DANS Easy).

IPD Sharing Time Frame

After publication of the main results of our trial.

IPD Sharing Access Criteria

Access to the data is restricted, meaning that researchers who are interested in re-use of the data are asked to contact the central contact person for permission. Approval is given after a signed agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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