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Parkinson DiseasePERSPECTIVENCT03963388

PERsonalized SPEeCh Therapy for actIVE Conversation

A study testing Speech therapy in people with Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Speech therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
1 siteNetherlands
Study dates
1 Mar 2019to 10 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud university medical center

    Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

About this study

Official title: 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.

Read more

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).

Being tested
Speech therapy
Keywords
Speech therapy, Telerehabilitation, Quality of life
Medical subject headings
Parkinson Disease, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speech therapyOther

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

Study groups in NCT03963388
Study groupRoleWhat they receive
Intervention groupExperimentalSpeech therapy, right after T0 (baseline measurement).
Receives: Other: Speech therapy
Control groupNo interventionPatients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-specific health-related quality of life

    Parkinson's Disease Questionnaire (PDQ-39)

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

Secondary outcomes (10)

  1. Speech quality

    Radboud Dysarthria Assessment (RDA)

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

  2. Voice quality

    Acoustic Voice Quality Index (AVQI)

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

  3. Voice handicap

    Voice Handicap Index (VHI)

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

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

    Radboud Oral Motor inventory for Parkinson's disease (ROMP)

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

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

    Radboud Oral Motor inventory for Parkinson's disease (ROMP), adapted to caregiver

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

  6. Speech intelligibility

    Dutch intelligibility test - sentence level (NSVO-Z)

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

  7. Caregiver burden

    Zarit caregiver Burden Interview Short Form (ZBI-12)

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

  8. Mood and anxiety

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 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).

  9. Health-related quality of life

    EuroQol-5D (EQ-5D)

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

  10. Swallowing

    Maximum swallowing speed (timed test)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2019
  2. Study start1 Mar 2019
  3. Primary completion10 Nov 2021
  4. Study completion10 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03963388
Sponsor's protocol ID
NL67867.091.18
Acronym
PERSPECTIVE
Status last verified
May 2023
First submitted
9 May 2019
Last updated
30 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will make relevant and anonymised data available in a validated database (DANS Easy).

Publications

  • 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.

    PubMed 22895930

  • 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.

    PubMed 22895931

  • Maas JJL, de Vries NM, IntHout J, Bloem BR, Kalf JG. Effectiveness of remotely delivered speech therapy in persons with Parkinson's disease - a randomised controlled trial. EClinicalMedicine. 2024 Sep 11;76:102823. doi: 10.1016/j.eclinm.2024.102823. eCollection 2024 Oct.

    PubMed 39309726

  • 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.

    PubMed 35395953

Questions about this trial

What is this clinical trial studying?

A study testing Speech therapy in people with Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-specific health-related quality of life (time frame: Baseline (T0), primary endpoint after 8 weeks (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03963388, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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