Effects of the Nintendo Wii Fit Game Training on Balance
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2018
CompletedFirst Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedJune 12, 2019
June 1, 2019
3 months
June 6, 2019
June 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Timed Up and Go (TUG) test- Change
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).
"Baseline and after 8 weeks"
Nintendo Wii Balance Board (NWBB)- Change
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).
"Baseline and after 8 weeks"
Other Outcomes (1)
Montreal Cognitive Assessment (MoCA) test
"Baseline"
Study Arms (2)
Intervention group
EXPERIMENTALThe 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.
Control group
NO INTERVENTIONParticipants 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.
Interventions
Numerous video games exist to interact with the Wii Balance Board. One game that has been used in prior balance studies is Wii Fit. On the first 4 weeks, balance training started with "Soccer Heading" game. The participants were asked to control their avatar by leaning to left or to the right in order to avoid the objects that were thrown towards them, and try to score the balls inside the net. The participants performed 3 sets of 5 rounds (2min each), totaling 30 min, and rested for 1 min between each set. "Table Tilt" game continued for the remaining 4 weeks. Participants tried to enter balls into the holes by shifting their body weight on the balance board causing it to tilt in all directions. This game was divided into multiple levels of 30 seconds each, repeated over 30 min, with a one-minute rest interval between every 10 minutes of training. Moreover, 20 extra seconds were added each time a participant has won a level.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lebanese German University
Jounieh, Keserwan, 00961, Lebanon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinator
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 12, 2019
Study Start
July 1, 2018
Primary Completion
September 20, 2018
Study Completion
September 20, 2018
Last Updated
June 12, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share