NCT03983642

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

June 6, 2019

Last Update Submit

June 11, 2019

Conditions

Keywords

Dynamic balanceStatic balanceWii FitElderly

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

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.

Device: Wii balance board

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.

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.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

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

Locations