Effects of Early Sleep After Action Observation Therapy on Balance in Elderly
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 主要终点
- Changes in Four Step Square Test
研究概览
简要总结
The study aims at investigating the effects of an early sleep window after Action Observation Therapy (AOT) on balance in elderly. Forty-five healthy-like elderly will be enrolled and randomized into 3 groups (AOT-sleep, AOT-control and Control) performing a 3-week AOT. AOT-sleep and AOT-control will be asked to watch video-clips showing motor contents before sleeping or at least 12 hours before sleeping, respectively, whereas Control will be asked to watch landascape video-clips before sleeping. Participants will be assessed before and after training and at 1 month follow-up for balance outcomes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to walk for at least 100 meters with no assistance or aids
排除标准
- •Musculoskeletal disorders able to affect balance
- •Traumas and/or injuries and/or surgery at the level of the lower limbs, spine in the previous year
- •Sleep disorders
- •Drugs able to affect sleep
- •Dementia or cognitive decline (MCI)
- •Psychiatric or neurological disorders
结局指标
主要结局
Changes in Four Step Square Test
时间窗: At baseline, 3 weeks of training and 1 month after the training end
The outcome measure is aimed at investigating changes in terms of dynamic balance
Changes in Timed Up and Go Test
时间窗: At baseline, 3 weeks of training and 1 month after the training end
The outcome measure is aimed at investigating changes in terms of mobility
Changes in Lower Quarter Y-Balance Test
时间窗: At baseline, 3 weeks and 1 month after the training end
The outcome measure is aimed at investigating changes in terms of static balance
Changes in 10-Meter Walking Test
时间窗: At baseline, 3 weeks of training and 1 month after the training end
The outcome measure is aimed at investigating changes in terms of gait speed
次要结局
- Morningness Eveningness Scale(At baseline)
- Euro Quality of Life - 5 dimensions(At baseline)
- Changes in center of pressure parameters(At baseline, 3 weeks of training and 1 month after the training end)
- Changes in Fall Efficacy Scale(At baseline, 3 weeks of training and 1 month after the training end)
- Pittsburg Quality Sleep Index(3 weeks)
- Kinesthetic and Visual Imagery Questionnaire(At baseline)
研究者
Michele Tedeschi
Principal Investigator
Istituto Clinico Humanitas