An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Speech Intelligibility at 6 Months
研究概览
简要总结
Nearly 90% of people with Parkinson's disease have speech and voice disorders that negatively impact their ability to communicate effectively in daily life. This study will test the hypothesis that a combined speech and exercise intervention will improve speech intelligibility in people with Parkinson's disease and speech impairment. This approach would offer an affordable way to continue to both instruct and encourage training by Veterans virtually indefinitely through the remote access technology. These findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and speech impairment.
详细描述
Background/Rationale The great majority of individuals with Parkinson's disease (PD) develop speech impairments, most of which are grouped together and called hypokinetic dysarthria. Hypokinetic dysarthria is typically characterized by altered prosody (e.g., reduced loudness and pitch variation), phonation (e.g., breathy or harsh voice), and articulation (e.g., imprecise consonants, centralized vowels). Changes in speech may appear early in PD and progress in severity over time. Further, such changes in speech lead to significant declines in functional communication and quality of life. Pharmacological and surgical interventions that alleviate motor symptoms in PD are largely ineffective or sometimes even detrimental for speech.
Objectives Based on results from a preliminary study, the investigators propose to conduct a pilot randomized, controlled trial in patients with hypokinetic dysarthria in PD to assess the potential effectiveness of a novel home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. The investigators hypothesize that patients in the intervention program will improve in speech intelligibility and self-perceived communication ability over 6 months, as compared with patients in a health education program.
Methods A total of 104 community-dwelling Veterans with hypokinetic dysarthria in mild-to-moderate PD will be randomly assigned to the exercise intervention or to the health education control. The investigators will test the effects of the intervention at 6 months for the outcomes speech intelligibility and self-perceived communication ability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of idiopathic Parkinson's disease (PD)
- •At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
- •Response to dopaminergic medication
- •Hypokinetic dysarthria
排除标准
- •Angina pectoris
- •History of myocardial infarction (MI) within 6 months
- •History of ventricular dysrhythmia requiring current therapy
研究组 & 干预措施
Combined speech and exercise intervention
Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.
干预措施: Combined speech and exercise intervention (Behavioral)
Control group
Health education
干预措施: Health education (Behavioral)
结局指标
主要结局
Change in Speech Intelligibility at 6 Months
时间窗: Baseline and 6-month Follow-up
Speech intelligibility is the degree to which spoken language can be understood by a listener. It is measured by the percentage of words that are understood from a recording of a participant reading a random set of 11 sentences from the Assessment of Intelligibility in Dysarthric Speech Sentence Intelligibility Test stimulus bank. Native speakers of American English listened to these recordings to assess speech intelligibility. These listeners were between the ages of 18 and 35 with no history of speech, language, or hearing disorders or experience rating speech. Each listener was provided with one sentence from each study participant's recording. Listeners were asked to transcribe each sentence to the best of their ability. Their transcriptions were compared with the actual sentences to calculate the percentage of words that were understood. Possible scores range from 0 (no words understood) to 100 (all words understood). Change = (6-month score - Baseline score)
次要结局
- Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months(Baseline and 6-month Follow-up)