Self Mobility Improvement in the Elderly by Counteracting Falls (SMILING)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- gait analysis
研究概览
简要总结
Experimental design overview:
The proposed project is a prospective experimental study design. Independent old adults (age 65 years old and older) who suffer from minor balance problems willing to participate in the study will be tested with well-established measuring techniques of balance and gait before and 4 weeks after balance training program using the "Self Mobility Improvement in the Elderly by Counteracting Falls" system (SMILING system). The study design is randomized clinical trial (RCT), cross over, single blinded study design where 30 subjects will randomly be allocated into experimental or control groups that will switch groups after 4 weeks of intervention.
Random sequence generation will be performed by a staff member who will not interact with subjects during the balance-testing sessions. Subjects will be informed that they are to be randomly assigned to one of the two groups, both receiving gait training program.
The staff member who administers the training programs will be the only member of the research team aware of the subjects' group allocations.
A 'blinded' research assistant will administer the balance tests and will perform any data processing that involves subjective judgments.
Scripts will be used during testing to ensure that all subjects receive the same instructions.
Testing session between two training periods (T1) will take one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
gait analysis
时间窗: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)
次要结局
- Tinetti's performance-oriented mobility assessment (POMA score), CODEX test, GDS test(time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test))
- CODEX test(time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test))
- GDS test(time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test))
