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Abstract：
To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson\'s disease.
Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial.
The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020.
388 people with Parkinson\'s disease and dysarthria.
Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants\' needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle.
The primary outcome was total score at three months of self-reported voice handicap index.
People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (-8.0 points (99% confidence interval -13.3 to -2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (-3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (-9.6 points (-14.9 to -4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded.
LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy.
ISRCTN registry ISRCTN12421382.
Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial.
The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020.
388 people with Parkinson\'s disease and dysarthria.
Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants\' needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle.
The primary outcome was total score at three months of self-reported voice handicap index.
People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (-8.0 points (99% confidence interval -13.3 to -2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (-3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (-9.6 points (-14.9 to -4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded.
LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy.
ISRCTN registry ISRCTN12421382.
摘要：
目的：评估两种言语和语言治疗方法对帕金森病患者构音障碍的临床疗效。
方法：务实，基于英国，多中心,三臂,平行组,未失明,随机对照试验。
方法：在2016年9月26日至2020年3月16日期间，在门诊或家庭环境中进行了言语和语言治疗干预。
方法：388名帕金森病和构音障碍患者。
方法：参与者被随机分配到三组中的一组（1：1：1）：130接受LeeSilverman语音治疗（LSVTLOUD），129到NHS言语和语言治疗，和129没有言语和语言治疗。LSVTLOUD由四个人组成，面对面或远程，每周50分钟的会议在四周内交付。基于家庭的实践活动在治疗日设置为每天5-10分钟,在非治疗日设置为每天两次15分钟。NHS言语和语言治疗的剂量由当地治疗师根据参与者的需求确定（根据先前的研究估计，NHS言语和语言治疗参与者将在六到八周内每周平均接受一次会议）。接受了NHS言语和语言治疗的当地做法，除了LSVTLOUD协议中的那些。分析基于意向治疗原则。
方法：主要结果是三个月自我报告的嗓音障碍指数的总分。
结果：接受LSVTLOUD的患者在随机化后3个月的嗓音障碍指数得分低于未接受言语和语言治疗的患者（-8.0分（99%置信区间-13.3至-2.6）；P<0.001）。没有证据表明NHS言语和语言治疗与无言语和语言治疗之间的语音障碍指数得分存在差异（1.7分（-3.8至7.1）；P=0.43）。LSVTLOUD组患者的嗓音障碍指数得分也低于随机接受NHS言语和语言治疗的患者（-9.6分（-14.9至-4.4）；P<0.001）。LSVTLOUD组报告了93起不良事件（主要是声带拉伤），NHS言语和语言治疗组46人，没有言语和语言治疗组。无严重不良事件记录。
结论：LSVTLOUD在减少参与者报告的声音问题影响方面比没有言语和语言治疗和NHS言语和语言治疗更有效。与没有言语和语言治疗相比，NHS言语和语言治疗没有任何益处的证据。
背景：ISRCTN注册表ISRCTN12421382。
方法：务实，基于英国，多中心,三臂,平行组,未失明,随机对照试验。
方法：在2016年9月26日至2020年3月16日期间，在门诊或家庭环境中进行了言语和语言治疗干预。
方法：388名帕金森病和构音障碍患者。
方法：参与者被随机分配到三组中的一组（1：1：1）：130接受LeeSilverman语音治疗（LSVTLOUD），129到NHS言语和语言治疗，和129没有言语和语言治疗。LSVTLOUD由四个人组成，面对面或远程，每周50分钟的会议在四周内交付。基于家庭的实践活动在治疗日设置为每天5-10分钟,在非治疗日设置为每天两次15分钟。NHS言语和语言治疗的剂量由当地治疗师根据参与者的需求确定（根据先前的研究估计，NHS言语和语言治疗参与者将在六到八周内每周平均接受一次会议）。接受了NHS言语和语言治疗的当地做法，除了LSVTLOUD协议中的那些。分析基于意向治疗原则。
方法：主要结果是三个月自我报告的嗓音障碍指数的总分。
结果：接受LSVTLOUD的患者在随机化后3个月的嗓音障碍指数得分低于未接受言语和语言治疗的患者（-8.0分（99%置信区间-13.3至-2.6）；P<0.001）。没有证据表明NHS言语和语言治疗与无言语和语言治疗之间的语音障碍指数得分存在差异（1.7分（-3.8至7.1）；P=0.43）。LSVTLOUD组患者的嗓音障碍指数得分也低于随机接受NHS言语和语言治疗的患者（-9.6分（-14.9至-4.4）；P<0.001）。LSVTLOUD组报告了93起不良事件（主要是声带拉伤），NHS言语和语言治疗组46人，没有言语和语言治疗组。无严重不良事件记录。
结论：LSVTLOUD在减少参与者报告的声音问题影响方面比没有言语和语言治疗和NHS言语和语言治疗更有效。与没有言语和语言治疗相比，NHS言语和语言治疗没有任何益处的证据。
背景：ISRCTN注册表ISRCTN12421382。
