PERsonalized SPEeCh Therapy for actIVE Conversation

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Speech therapy

• Registration Number: NCT03963388
• Lead Sponsor: Radboud University Medical Center

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Speech therapy	Speech therapy, right after T0 (baseline measurement).

Primary Outcome Measures

Name	Time	Method
Disease-specific health-related quality of life	Baseline (T0), primary endpoint after 8 weeks (T1)	Parkinson's Disease Questionnaire (PDQ-39)

Secondary Outcome Measures

Name	Time	Method
Voice quality	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Acoustic Voice Quality Index (AVQI)
Caregiver burden	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Zarit caregiver Burden Interview Short Form (ZBI-12)
Speech quality	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Radboud Dysarthria Assessment (RDA)
Voice handicap	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Voice Handicap Index (VHI)
Severity of voice and speech complaints, reported by patient	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Radboud Oral Motor inventory for Parkinson's disease (ROMP)
Severity of voice and speech complaints, reported by caregiver	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
Speech intelligibility	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Dutch intelligibility test - sentence level (NSVO-Z)
Mood and anxiety	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)
Swallowing	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	Maximum swallowing speed (timed test)
Health-related quality of life	Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2)	EuroQol-5D (EQ-5D)

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands