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临床试验/NCT03983642
NCT03983642已完成不适用

Effects of the Nintendo Wii Fit Game Training on Balance Among Lebanese Elderly

Lebanese German University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Nintendo Wii Balance Board (NWBB)- Change

研究概览

简要总结

This study is a single-blinded prospective longitudinal randomized controlled trial (RCT). The experiment took place over a period of eight weeks. Elderly participants were randomized into two groups (intervention and control). Participants of each group were followed-up carefully by assessors over three times per week, for a total of 24 sessions and during the data collection periods as well. Dynamic and static balance measures were compared between the groups on two occasions (baseline, and post-test). Timed Up and Go (TUG) test, and the Nintendo Wii Balance Board (NWBB) were used to measure the dynamic and static balance respectively.

详细描述

Design

This study embraced an experimental randomized controlled trial (RCT) design, where both baseline and post-test measures were recorded for both the dynamic and static balance. Ethical approval was obtained from the Lebanese German University Institutional Review Board. Every participant in this study received an information sheet which contains sections on (a) research purpose, (b) voluntary participation, (c) study protocol, (d) risks and benefits, (e) confidentiality, and (f) contact personals.

Participants and Selection Criteria

After a random selection of both of Tyre and Saida districts to represent the South governorate (cluster sampling), all the geriatric centers present in these areas were included in the study.

Participants inclusion criteria included (a) age of 65 years and above, (b) impaired dynamic balance characterized by TUG test score >14 seconds, (c) Montreal Cognitive Assessment (MoCA) test score ≥ 23, (d)good vision, and (e) no vestibular disorders. On the other hand, (a) those who were on a wheelchair or used walkers for mobility, (b) sustained a fracture or underwent orthopedic surgery to the lower extremities within the last 6 months, and (c) have an amputated limb, were excluded. After applying the inclusion and exclusion criteria, 64 participants remained and accepted to enroll in the study. Four of these participants dropped -out eventually, three from the intervention group, and one from the control group, leaving these two groups equally split.

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
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

入选标准

  • age of 65 years and above,
  • impaired dynamic balance characterized by TUG test score >14 seconds,
  • Montreal Cognitive Assessment (MoCA) test score ≥ 23,
  • good vision,
  • no vestibular disorders.

排除标准

  • those who were on a wheelchair or used walkers for mobility,
  • sustained a fracture or underwent orthopedic surgery to the lower extremities within the last 6 months,
  • have an amputated limb.

研究组 & 干预措施

Intervention group

Experimental

The intervention group received a session of 40min for an 8 weeks' period. Both games requested the participants to stand on a balance board in front of the television, without shoes, while trying to control their avatars by shifting their body weights.

干预措施: Wii balance board (Device)

Control group

No Intervention

Participants in the control group were followed-up by an assessor, who made sure that they will not get involved in any type of training program during the eight weeks' period of the trial.

结局指标

主要结局

Nintendo Wii Balance Board (NWBB)- Change

时间窗: "Baseline and after 8 weeks"

The NWBB (Nintendo, Kyoto, Japan), is a 26 cm× 44 cm rigid low-cost force platform with four uni-axial vertical force transducers located in the feet at the corners of the board, one transducer per foot. Each transducer is a load cell consisting of a metal bar with a strain gauge that converts applied force to a voltage that is digitized and transmitted wirelessly by electronics in the NWBB (Ogasawara, 2012). To collect data from the NWBB, data was streamed to a computer (Lenovo, Windows 10) using the Bluetooth HID wireless protocol and custom programs written in Java (Oracle) and Matlab (Mathworks, Natick, MA). Good-to-excellent test-retest reproducibility has been demonstrated during static bilateral stance (Clark et al., 2010). Similarly, the inter-rater reliability (ICC: 0.79-0.89) was considered high in terms of COP path length and COP velocity (Ogasawara, 2012). In addition, good-to-excellent concurrent validity was observed (Clark et al, 2010).

Timed Up and Go (TUG) test- Change

时间窗: "Baseline and after 8 weeks"

The TUG test is a simple yet effective test that assesses a person's balance in mobility. The participant is asked to sit on a chair, rise up, walk three meters, turn around and return to sit on the chair. The time was measured using a stopwatch in seconds. Normative values for age groups were as follows: (a) 60-69 years between 7.1 - 9.0 seconds; b) 70-79 years between 8.2 - 10.2 seconds; and c) 80-99 years between 10.0 - 12.7 seconds. Participants who finished with a score above 14 seconds were associated with high risks of falls (Bohannon, 2006). Intratester and intertester reliability have been reported as high in elderly populations (ICC = 0.92-0.99) (Steffen, Hacker, \& Mollinger, 2002).

次要结局

未报告次要终点

研究者

发起方
Lebanese German University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Ali FAKHRO, DPT

Coordinator

Lebanese German University

研究点 (2)

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