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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Speech therapy, right after T0 (baseline measurement). |
|
| Control group | No Intervention | Patients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-specific health-related quality of life | Parkinson's Disease Questionnaire (PDQ-39) | Baseline (T0), primary endpoint after 8 weeks (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Speech quality | Radboud Dysarthria Assessment (RDA) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) |
| Voice quality | Acoustic Voice Quality Index (AVQI) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-specific health-related quality of life (follow-up) | Parkinson's Disease Questionnaire (PDQ-39) | Primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bastiaan R Bloem, MD, PhD | Department of Neurology, Radboudumc, Nijmegen, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Nijmegen | Gelderland | 6500HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22895930 | Background | 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. | |
| 22895931 | 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. |
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We will make relevant and anonymised data available in a validated database (DANS Easy).
After publication of the main results of our trial.
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.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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The assessors will be blinded for treatment allocation.
| Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) |
| Voice handicap | 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 | 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 | 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 | Dutch intelligibility test - sentence level (NSVO-Z) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) |
| Caregiver burden | 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 | 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 | EuroQol-5D (EQ-5D) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) |
| Swallowing | Maximum swallowing speed (timed test) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) |
| 39309726 | Derived | 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. |
| 35395953 | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D005791 | Patient Care |
| D013812 | Therapeutics |