NCT04302155

Brief Summary

Balance play a vital role to increase motor skills in healthy young adults. With increasing age balance control ability decreases,this decline can result as early as mid-30s. In young adults focus on improving anticipatory postural control so risk of lower extremity injuries especially ankle and knee injuries can be minimized and future risk of fall can be minimized.Objective is To compare the effect of traditional versus Wii fit training on balance in young adults the participants were randomly assigned into two groups interventional and control. total 18 minutes session was given to both groups wii fit group and traditional balance training group. all participants were given 3 sessions per week for 6. participants were initially accessed initially for eligibility , these participants were randomly divided into wii fit and traditional training group through sealed enveloped method . the initial assessment was done on wii fit. balance intervention to wii fit group is different games available on wii fit software. balance intervention given to traditional group is on trampoline and on BOSU ball.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

March 6, 2020

Last Update Submit

October 8, 2020

Conditions

Keywords

Wii FitBalance TrainingYoung Adult

Outcome Measures

Primary Outcomes (3)

  • Fullerton advance balance test (FAB)

    As per baseline assessment.This test is basically used to identify the balance problem in active adults. This test is used for the assessment of static and dynamic balance assessment under different situations. It include 10 activities, its total score is 40 cut off score is 25. \>25 means risk of fall absent. \<25 means risk of fall present. Its test retest reliability is (ICC=0.98) Components of FAB: * Stand with feet together and eyes closed * Reach forward to retrieve an object (pencil) held at shoulder height with outstretched arm * Turn 360 degrees in right and left directions * Step up onto and over a 6-inch bench * Tandem walk * Stand on one leg * Stand on foam with eyes closed * Two-footed jump * Walk with head turns * Reactive postural control

    4 weeks

  • Y balance test:

    As per baseline assessment.Y-Balance Test is reliable tool for balance assessment. The person stand on one leg and simultaneously reaches other leg far in three directions:anterior, posterolateral, posteromedial. It measures muscle's flexibility, strength and balance

    4 weeks

  • Wii fit system

    As per baseline assessment. Wii fit is also used for static and dynamic center of pressure control. According to dynamic center of pressure variation from midline during performing different task Wii fit age is calculated.

    4 weeks

Study Arms (2)

Nintendo Wii

EXPERIMENTAL

Balance-specific exer-games focusing on dynamic aspects of center of pressure (COP) on Wii fit system.

Other: balance-specific -games focusing on dynamic aspects of COP on Wii fit system.

Traditional

EXPERIMENTAL

Mini trampoline two balance exercises of 6 minutes on mini trampoline for a total duration of 3 min on each leg Inflatable discs 4 balance exercises of 12 minutes on BOSU ball 6 minutes on rounded side and 6 minutes on rigid side.

Other: mini trampoline and inflatable discs group

Interventions

The participants were randomly assigned into two groups interventional and control. Total 18 minutes session was given to both groups wii fit group and traditional balance training group. All participants were given 3 sessions per week for 6. Total 48 participants were initially accessed initially for eligibility , 13 participants were excluded because of having good balance and good balance age score on Wii fit assessment, 35 participants were recruited for balance training. These participants were randomly divided into Wii fit and traditional training group through sealed enveloped method 18 participants was recruited in Wii fit group and 17 in traditional balance training group. 3 participants drop out from Wii fit group and 2 from traditional balance training group. Some examples include catching apples in a basket ,moving a golf ball around barriers towards a hole , popping rising balloons/bubbles and air hockey .

Nintendo Wii

High skipping and landing on a limb every time (2 repeats of 45 s each leg).Standing on one leg and try to catch the ball thrown at them in various directions by the researcher (2 repeats of 45 s each leg) Exercises in inFlated rubber hemisphere attached toa rigid platform (BOSU) 1. Standing on BOSU's round soft surface with one foot, in an attempt to maintain balance (2 repeats of 45 s each leg). 2. Standing on BOSU's round soft surface with one foot, in an attempt to maintain balance, while lifting the non-support leg forward and backward (2 repeats of 45 s each leg). 3. Standing on BOSU flat hard surface with both legs, in an attempt to maintain balance (3 minutes on both legs). 4. Standing on BOSUs flat hard surface with both feet, in an attempt to maintain balance, while trying to catch the ball thrown at them by the experimenter in various directions (3 minutes on both leg)

Traditional

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults (18 to 30 years)
  • Either gender
  • having static standing balance of 30 seconds with eye open and eye close.
  • Willing to participate
  • Normal or corrected vision and hearing, no history of primary medical risk factors for falls
  • Adults having wii fit balance age greater \> years from their actual age

You may not qualify if:

  • Young adults with any diagnosed balance issue
  • Young adults with pathology of the musculoskeletal, neurological or vestibular system, severe cardiovascular disease, diabetes, adults using beta-blockers or antidepressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (7)

  • Pompeu JE, Mendes FA, Silva KG, Lobo AM, Oliveira Tde P, Zomignani AP, Piemonte ME. Effect of Nintendo Wii-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial. Physiotherapy. 2012 Sep;98(3):196-204. doi: 10.1016/j.physio.2012.06.004. Epub 2012 Jul 25.

    PMID: 22898575BACKGROUND
  • Chang WD, Chang WY, Lee CL, Feng CY. Validity and reliability of wii fit balance board for the assessment of balance of healthy young adults and the elderly. J Phys Ther Sci. 2013 Oct;25(10):1251-3. doi: 10.1589/jpts.25.1251. Epub 2013 Nov 20.

    PMID: 24259769BACKGROUND
  • Whyatt C, Merriman NA, Young WR, Newell FN, Craig C. A Wii Bit of Fun: A Novel Platform to Deliver Effective Balance Training to Older Adults. Games Health J. 2015 Dec;4(6):423-33. doi: 10.1089/g4h.2015.0006. Epub 2015 Oct 15.

    PMID: 26469308BACKGROUND
  • Lange B, Chang CY, Suma E, Newman B, Rizzo AS, Bolas M. Development and evaluation of low cost game-based balance rehabilitation tool using the Microsoft Kinect sensor. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1831-4. doi: 10.1109/IEMBS.2011.6090521.

    PMID: 22254685BACKGROUND
  • Goble DJ, Cone BL, Fling BW. Using the Wii Fit as a tool for balance assessment and neurorehabilitation: the first half decade of "Wii-search". J Neuroeng Rehabil. 2014 Feb 8;11:12. doi: 10.1186/1743-0003-11-12.

    PMID: 24507245BACKGROUND
  • Meldrum D, Glennon A, Herdman S, Murray D, McConn-Walsh R. Virtual reality rehabilitation of balance: assessment of the usability of the Nintendo Wii((R)) Fit Plus. Disabil Rehabil Assist Technol. 2012 May;7(3):205-10. doi: 10.3109/17483107.2011.616922. Epub 2011 Nov 25.

    PMID: 22117107BACKGROUND
  • Franco JR, Jacobs K, Inzerillo C, Kluzik J. The effect of the Nintendo Wii Fit and exercise in improving balance and quality of life in community dwelling elders. Technol Health Care. 2012;20(2):95-115. doi: 10.3233/THC-2011-0661.

    PMID: 22508022BACKGROUND

Study Officials

  • Arshad Nawaz Malik, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

August 15, 2018

Primary Completion

December 30, 2018

Study Completion

January 15, 2019

Last Updated

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations