The PERSPECTIVE Study: PERsonalized SPEeCh Therapy for actIVE Conversation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Disease-specific health-related quality of life
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessors will be blinded for treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
Speech therapy, right after T0 (baseline measurement).
干预措施: Speech therapy (Other)
Control group
Patients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech therapy.
结局指标
主要结局
Disease-specific health-related quality of life
时间窗: Baseline (T0), primary endpoint after 8 weeks (T1)
Parkinson's Disease Questionnaire (PDQ-39)
次要结局
- Speech 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))
- Speech intelligibility(Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2))
- 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).)
- Swallowing(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))
- Caregiver burden(Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2))
- Health-related quality of life(Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2))