Efficacy of Interactive Modular Tiles Training Versus "Usual Care" on Physical Attributes Among Elder Adults 70+. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.
研究概览
简要总结
This study evaluates the use of Playware technology for balance training. Falling among elder is a costly problem. Research shows that training can help prevent falls. Pilot studies of the use of Interactive Modular Tiles (IMT) show that the participants can highly increase their physical abilities.
The interventions group will train using interactive modular tiles. The tiles include preprogrammed games that create playful training for the participants.
The control group will receive "usual care", which here refers to normal day activities.
The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time.
详细描述
This study will investigate the use of one form of exergames called IMT how this compared to usual care of elderly people 70+. The trial will consist of two groups, one for training with the IMT and usual care that will receive the care provided to non-patients elderly, which at this moment is no additional treatment other than recommendations.
The study will be single blinded, randomized controlled trial. It will be funded by the patient@home project and Entertainment robotics. Concealed allocation and intention-to-treat analysis will be used. Measurements will be taken at baseline and after intervention. Upon acceptance the protocol will be registered in clinicaltrials.gov.
The trial's results will be reported using domains and categories described in the taxonomy developed by the Prevention of Falls Network Europe, to allow future synthesis of evidence, or study replication.
The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.
The control group will not train.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling
- •70+ years
排除标准
- •A previous diagnosis of strong dementia or a cognitive decline that prevents the understanding of simple instructions or guidelines;
- •A previous stroke with a severe neurological impairment, such as loss of strength, and perceptual or language limitations;
- •A severe visual deficiency;
- •Inability to maintain a standing position, even with the use of a walking aid or other device;
- •Participating in rehabilitative training.
研究组 & 干预措施
Training
The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.
The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).
干预措施: Training on Interactive Modulare Tiles (Device)
Control
No training.
结局指标
主要结局
Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.
时间窗: Baseline and at week 14
Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.
Change From Baseline in Test Score of 30-second Chair Stand at Week 14.
时间窗: Baseline and at week 14
Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.
Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.
时间窗: Baseline and at week 14
Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.
次要结局
- Change From Baseline in Test Score of Line Walk at Week 14.(Baseline and at week 14)
- Change From Baseline in Test Score of Static Balance at Week 14.(Baseline and at week 14)
- Adherence to Training, Composite Outcome Measure.(At week 14)
- Motivation for Training(At week 14.)
- Acceptability of IMT(At week 14.)
研究者
Jari Due Jessen
PhD Student
Technical University of Denmark