PERsonalized SPEeCh Therapy for actIVE Conversation

NCT03963388 | Completed DMC

• 1 other identifier: NL67867.091.18
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Keywords

Speech therapy; Telerehabilitation; Quality of life

Outcome Measures

Primary Outcomes (1)

• Disease-specific health-related quality of life

  Parkinson's Disease Questionnaire (PDQ-39)

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

Secondary Outcomes (10)

• Speech quality

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

• Voice quality

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

• Voice handicap

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

• Severity of voice and speech complaints, reported by patient

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

• Severity of voice and speech complaints, reported by caregiver

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

Other Outcomes (1)

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

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

Study Arms (2)

Intervention group

EXPERIMENTAL

Speech therapy, right after T0 (baseline measurement).

Other: Speech therapy

Control group

NO INTERVENTION

Patients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech therapy.

Interventions

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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 22895930 BACKGROUND

• 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.

  PMID: 22895931 BACKGROUND

• 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.

  PMID: 39309726 DERIVED

• 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.

  PMID: 35395953 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Communication Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Bastiaan R Bloem, MD, PhD

  Department of Neurology, Radboudumc, Nijmegen, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will be blinded for treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 24, 2019
• Study Start: March 1, 2019
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of the main results of our trial.
• 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.

Locations

NL (1)