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Abstract：
BACKGROUND: Actual and imagined cued gait trainings have not been compared in people with multiple sclerosis (MS).
OBJECTIVE: To analyze the effects of cued motor imagery (CMI), cued gait training (CGT), and combined CMI and cued gait training (CMI-CGT) on motor, cognitive, and emotional functioning, and health-related quality of life in people with MS.
METHODS: In this double-blind randomized parallel-group multicenter trial, people with MS were randomized (1:1:1) to CMI, CMI-CGT, or CGT for 30 minutes, 4×/week for 4 weeks. Patients practiced at home, using recorded instructions, and supported by ≥6 phone calls. Data were collected at weeks 0, 4, and 13. Co-primary outcomes were walking speed and distance, analyzed by intention-to-treat. Secondary outcomes were global cognitive impairment, anxiety, depression, suicidality, fatigue, HRQoL, motor imagery ability, music-induced motivation, pleasure and arousal, self-efficacy, and cognitive function. Adverse events and falls were continuously monitored.
RESULTS: Of 1559 screened patients, 132 were randomized: 44 to CMI, 44 to CMI-CGT, and 44 to CGT. None of the interventions demonstrated superiority in influencing walking speed or distance, with negligible effects on walking speed (η2 = 0.019) and distance (η2 = 0.005) observed in the between-group comparison. Improvements in walking speed and walking distance over time corresponded to large effects for CMI, CMI-CGT, and CGT (η2 = 0.348 and η2 = 0.454 respectively). No severe study-related adverse events were reported.
CONCLUSIONS: CMI-GT did not lead to improved walking speed and distance compared with CMI and CGT alone in people with MS. Lack of a true control group represents a study limitation.
BACKGROUND: German Clinical Trials Register, DRKS00023978.
OBJECTIVE: To analyze the effects of cued motor imagery (CMI), cued gait training (CGT), and combined CMI and cued gait training (CMI-CGT) on motor, cognitive, and emotional functioning, and health-related quality of life in people with MS.
METHODS: In this double-blind randomized parallel-group multicenter trial, people with MS were randomized (1:1:1) to CMI, CMI-CGT, or CGT for 30 minutes, 4×/week for 4 weeks. Patients practiced at home, using recorded instructions, and supported by ≥6 phone calls. Data were collected at weeks 0, 4, and 13. Co-primary outcomes were walking speed and distance, analyzed by intention-to-treat. Secondary outcomes were global cognitive impairment, anxiety, depression, suicidality, fatigue, HRQoL, motor imagery ability, music-induced motivation, pleasure and arousal, self-efficacy, and cognitive function. Adverse events and falls were continuously monitored.
RESULTS: Of 1559 screened patients, 132 were randomized: 44 to CMI, 44 to CMI-CGT, and 44 to CGT. None of the interventions demonstrated superiority in influencing walking speed or distance, with negligible effects on walking speed (η2 = 0.019) and distance (η2 = 0.005) observed in the between-group comparison. Improvements in walking speed and walking distance over time corresponded to large effects for CMI, CMI-CGT, and CGT (η2 = 0.348 and η2 = 0.454 respectively). No severe study-related adverse events were reported.
CONCLUSIONS: CMI-GT did not lead to improved walking speed and distance compared with CMI and CGT alone in people with MS. Lack of a true control group represents a study limitation.
BACKGROUND: German Clinical Trials Register, DRKS00023978.
摘要：
背景：在多发性硬化症（MS）患者中尚未比较实际和想象中的步态训练。
目的：分析提示运动想象（CMI）的影响，提示步态训练（CGT），结合CMI和提示步态训练（CMI-CGT）对运动，认知，和情感功能，MS患者与健康相关的生活质量
方法：在这项双盲随机平行组多中心试验中，MS患者被随机（1：1：1）接受CMI，CMI-CGT,或CGT30分钟，4×/周，共4周。病人在家练习，使用记录的说明，并支持≥6个电话。在第0、4和13周收集数据。共同的主要结果是步行速度和距离，通过意向治疗进行分析。次要结果是整体认知障碍，焦虑,抑郁症,自杀,疲劳,HRQoL,运动想象能力，音乐诱导的动机，快乐和唤醒，自我效能感,和认知功能。连续监测不良事件和跌倒。
结果：在1559名筛查患者中，132个被随机分配：44个给CMI，44到CMI-CGT，44到CGT。所有干预措施都没有显示出在影响步行速度或距离方面的优势，在组间比较中观察到的对步行速度（η2=0.019）和距离（η2=0.005）的影响可忽略不计。随着时间的推移，步行速度和步行距离的提高对应于CMI的巨大影响，CMI-CGT,和CGT(η2分别=0.348和η2=0.454)。未报告严重的研究相关不良事件。
结论：在MS患者中，与仅CMI和CGT相比，CMI-GT并未改善步行速度和距离。缺乏真正的对照组代表了研究的局限性。
背景：德国临床试验注册，DRKS00023978。
目的：分析提示运动想象（CMI）的影响，提示步态训练（CGT），结合CMI和提示步态训练（CMI-CGT）对运动，认知，和情感功能，MS患者与健康相关的生活质量
方法：在这项双盲随机平行组多中心试验中，MS患者被随机（1：1：1）接受CMI，CMI-CGT,或CGT30分钟，4×/周，共4周。病人在家练习，使用记录的说明，并支持≥6个电话。在第0、4和13周收集数据。共同的主要结果是步行速度和距离，通过意向治疗进行分析。次要结果是整体认知障碍，焦虑,抑郁症,自杀,疲劳,HRQoL,运动想象能力，音乐诱导的动机，快乐和唤醒，自我效能感,和认知功能。连续监测不良事件和跌倒。
结果：在1559名筛查患者中，132个被随机分配：44个给CMI，44到CMI-CGT，44到CGT。所有干预措施都没有显示出在影响步行速度或距离方面的优势，在组间比较中观察到的对步行速度（η2=0.019）和距离（η2=0.005）的影响可忽略不计。随着时间的推移，步行速度和步行距离的提高对应于CMI的巨大影响，CMI-CGT,和CGT(η2分别=0.348和η2=0.454)。未报告严重的研究相关不良事件。
结论：在MS患者中，与仅CMI和CGT相比，CMI-GT并未改善步行速度和距离。缺乏真正的对照组代表了研究的局限性。
背景：德国临床试验注册，DRKS00023978。
