PDF(Pubmed)
Abstract：
BACKGROUND: Smartphones can generate objective measures of Parkinson\'s disease (PD) and supplement traditional in-person rating scales. However, smartphone use in clinical trials has been limited.
OBJECTIVE: This study aimed to determine the feasibility of introducing a smartphone research application into a PD clinical trial and to evaluate the resulting measures.
METHODS: A smartphone application was introduced part-way into a phase 3 randomized clinical trial of inosine. The application included finger tapping, gait, and cognition tests, and participants were asked to complete an assessment battery at home and in clinic alongside the Movement Disorder Society-Unified Parkinson\'s Disease Rating Scale (MDS-UPDRS).
RESULTS: Of 236 eligible participants in the parent study, 88 (37%) consented to participate, and 59 (27 randomized to inosine and 32 to placebo) completed a baseline smartphone assessment. These 59 participants collectively completed 1,292 batteries of assessments. The proportion of participants who completed at least one smartphone assessment was 61% at 3, 54% at 6, and 35% at 12 months. Finger tapping speed correlated weakly with the part III motor portion (r = -0.16, left hand; r = -0.04, right hand) and total (r = -0.14) MDS-UPDRS. Gait speed correlated better with the same measures (r = -0.25, part III motor; r = -0.34, total). Over 6 months, finger tapping speed, gait speed, and memory scores did not differ between those randomized to active drug or placebo.
CONCLUSIONS: Introducing a smartphone application midway into a phase 3 clinical trial was challenging. Measures of bradykinesia and gait speed correlated modestly with traditional outcomes and were consistent with the study\'s overall findings, which found no benefit of the active drug.
OBJECTIVE: This study aimed to determine the feasibility of introducing a smartphone research application into a PD clinical trial and to evaluate the resulting measures.
METHODS: A smartphone application was introduced part-way into a phase 3 randomized clinical trial of inosine. The application included finger tapping, gait, and cognition tests, and participants were asked to complete an assessment battery at home and in clinic alongside the Movement Disorder Society-Unified Parkinson\'s Disease Rating Scale (MDS-UPDRS).
RESULTS: Of 236 eligible participants in the parent study, 88 (37%) consented to participate, and 59 (27 randomized to inosine and 32 to placebo) completed a baseline smartphone assessment. These 59 participants collectively completed 1,292 batteries of assessments. The proportion of participants who completed at least one smartphone assessment was 61% at 3, 54% at 6, and 35% at 12 months. Finger tapping speed correlated weakly with the part III motor portion (r = -0.16, left hand; r = -0.04, right hand) and total (r = -0.14) MDS-UPDRS. Gait speed correlated better with the same measures (r = -0.25, part III motor; r = -0.34, total). Over 6 months, finger tapping speed, gait speed, and memory scores did not differ between those randomized to active drug or placebo.
CONCLUSIONS: Introducing a smartphone application midway into a phase 3 clinical trial was challenging. Measures of bradykinesia and gait speed correlated modestly with traditional outcomes and were consistent with the study\'s overall findings, which found no benefit of the active drug.
摘要：
背景：智能手机可以生成帕金森病（PD）的客观指标，并补充传统的个人评定量表。然而,智能手机在临床试验中的使用受到限制。
目的：本研究旨在确定将智能手机研究应用程序引入PD临床试验的可行性，并评估由此产生的措施。
方法：将智能手机应用部分引入肌苷3期随机临床试验。该应用程序包括手指点击，步态,和认知测试，参与者被要求在家中和临床上完成一个评估电池，并与运动障碍协会-统一帕金森病评定量表（MDS-UPDRS）一起完成。
结果：在母体研究的236名合格参与者中，88（37%）同意参加，59人(27人随机接受肌苷治疗,32人接受安慰剂治疗)完成了智能手机基线评估.这59名参与者总共完成了1292个评估。完成至少一项智能手机评估的参与者比例为3％的61％，6％的54％和12个月的35％。手指敲击速度与III部分电机部分（r=-0.16，左手；r=-0.04，右手）和总（r=-0.14）MDS-UPDRS弱相关。步态速度与相同的测量值相关更好（r=-0.25，III部分运动；r=-0.34，总计）。超过6个月,手指敲击速度,步态速度,随机分配给活性药物或安慰剂的患者的记忆评分没有差异.
结论：在3期临床试验的中途引入智能手机应用具有挑战性。运动迟缓和步态速度的测量值与传统结果的相关性不大，并且与研究的总体结果一致。没有发现活性药物的益处。
目的：本研究旨在确定将智能手机研究应用程序引入PD临床试验的可行性，并评估由此产生的措施。
方法：将智能手机应用部分引入肌苷3期随机临床试验。该应用程序包括手指点击，步态,和认知测试，参与者被要求在家中和临床上完成一个评估电池，并与运动障碍协会-统一帕金森病评定量表（MDS-UPDRS）一起完成。
结果：在母体研究的236名合格参与者中，88（37%）同意参加，59人(27人随机接受肌苷治疗,32人接受安慰剂治疗)完成了智能手机基线评估.这59名参与者总共完成了1292个评估。完成至少一项智能手机评估的参与者比例为3％的61％，6％的54％和12个月的35％。手指敲击速度与III部分电机部分（r=-0.16，左手；r=-0.04，右手）和总（r=-0.14）MDS-UPDRS弱相关。步态速度与相同的测量值相关更好（r=-0.25，III部分运动；r=-0.34，总计）。超过6个月,手指敲击速度,步态速度,随机分配给活性药物或安慰剂的患者的记忆评分没有差异.
结论：在3期临床试验的中途引入智能手机应用具有挑战性。运动迟缓和步态速度的测量值与传统结果的相关性不大，并且与研究的总体结果一致。没有发现活性药物的益处。
