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Effects of the Nintendo Wii Fit Game Training on Balance

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ClinicalTrials.gov Identifier: NCT03983642
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed Ali FAKHRO, DPT, Lebanese German University

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.

Condition or disease Intervention/treatment Phase
Balance; Distorted Device: Wii balance board Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the Nintendo Wii Fit Game Training on Balance Among Lebanese Elderly
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

Arm Intervention/treatment
Experimental: Intervention group
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.
Device: Wii balance board

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.


No Intervention: Control group
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.



Primary Outcome Measures :
  1. Timed Up and Go (TUG) test- Change [ Time Frame: "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).


  2. Nintendo Wii Balance Board (NWBB)- Change [ Time Frame: "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).



Other Outcome Measures:
  1. Montreal Cognitive Assessment (MoCA) test [ Time Frame: "Baseline" ]

    The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It is a brief (30-question) test that takes around 10 to 12 minutes to administer. MoCA evaluates different types of cognitive abilities (Nasreddine et al., 2005).

    MoCA is scored by adding the total scores of items and the authors stated that a clinical cutoff score of 26 or above was to be considered normal. It was influenced by education, prompting the authors to recommend adding one point to the cut score for elders with over 12 years of education (Nasreddine et al., 2005). Subsequent studies have demonstrated a trend characterized by high sensitivity and low specificity for the MoCA. At a cutoff of 26, the MoCA yielded high sensitivity but low specificity, however, when a cut score of 23 was used, both sensitivity and specificity were excellent (0.96 and 0.95, respectively) (Luis, Keegan, & Mullan, 2009).




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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983642


Locations
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Lebanon
Lebanese German University
Jounieh, Keserwan, Lebanon, 00961
Sponsors and Collaborators
Lebanese German University

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Responsible Party: Mohammed Ali FAKHRO, DPT, Coordinator, Lebanese German University
ClinicalTrials.gov Identifier: NCT03983642     History of Changes
Other Study ID Numbers: Effects of Nintendo Wii Fit
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed Ali FAKHRO, DPT, Lebanese German University:
Dynamic balance
Static balance
Wii Fit
Elderly