NCT04414462

Brief Summary

Exergames showed beneficial effects than conventional exercises for gaze stability, balance and gait improvements in older individuals. Further studies should be conducted to explore the benefits of exergames on older adults. This study aims to explore that exergaming has more effects on gaze stability, balance and gait performance of older individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

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

First Submitted

Initial submission to the registry

May 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

May 30, 2020

Last Update Submit

March 6, 2021

Conditions

Keywords

Exergamingvestibular traininggaze stabilityBalanceGaitolder adults

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go test (TUG)

    TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down. Normal healthy elderly usually completes the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.

    Change from Baseline balance to 6th Weeks

  • Dynamic Visual Acuity

    It provides an objective and instrumented way of assessing Vestibulo-ocular reflex (VOR)function in response to rotational and functional head movement stimuli. The DVA testing system consisted of a personal computer with a monitor and a velocity sensor which is fixed on a headset to the participant's head. Minimum acceptable head testing velocity was 150◦/s.

    Change from Baseline vestibular ocular reflex to 6th Week

  • Dynamic Gait Index

    Dynamic gait index is used to assess gait, balance and fall risk. It is a valuable clinical tool for evaluating dynamic balance in community dwelling older adults. Total score is 24, a score \< 19/24 is predictive of falls risk in community dwelling elderly

    Change from Baseline gait to 6th Week

Secondary Outcomes (1)

  • Force Platform

    Change from Baseline postural variation to 6th Week

Study Arms (2)

Group I

EXPERIMENTAL

Group I will receive following exergaming training: heading, tightrope tension,snowboard slalom and table tilt game

Other: exergaming training

Group II

ACTIVE COMPARATOR

Group II will receive Habituation,wobble board exercises,double leg,single leg and tandem stance training.

Other: training - Group II

Interventions

* HEADING: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game) * TIGHTROPE TENSION: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game) * SNOWBOARD SLALOM: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game) * TABLE TILT: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)

Group I

* Wobble board for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks. * Habituation exercises for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks. * Double leg stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks. * Single leg stance with eyes open and eyes open on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks. * Tandem walk stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.

Group II

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A score of 21 and above on berg balance scale.
  • A minimum head velocity of 150◦/s on dynamic visual acuity test.

You may not qualify if:

  • Acute Musculoskeletal pain
  • Uncontrollable cardiovascular disease (e.g. High blood pressure, Uncontrolled sugar)
  • Weakness from known neurological problems (Parkinson's, stroke, multiple sclerosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan General Railway Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (6)

  • Tomita Y, Arima K, Tsujimoto R, Kawashiri SY, Nishimura T, Mizukami S, Okabe T, Tanaka N, Honda Y, Izutsu K, Yamamoto N, Ohmachi I, Kanagae M, Abe Y, Aoyagi K. Prevalence of fear of falling and associated factors among Japanese community-dwelling older adults. Medicine (Baltimore). 2018 Jan;97(4):e9721. doi: 10.1097/MD.0000000000009721.

    PMID: 29369207BACKGROUND
  • Siddiqi FA, Masood T, Osama M, Azim ME, Babur MN. Common balance measures and fall risk scores among older adults in Pakistan: Normative values and correlation. J Pak Med Assoc. 2019 Feb;69(2):246-249.

    PMID: 30804593BACKGROUND
  • Lee Y, Choi W, Lee K, Song C, Lee S. Virtual Reality Training With Three-Dimensional Video Games Improves Postural Balance and Lower Extremity Strength in Community-Dwelling Older Adults. J Aging Phys Act. 2017 Oct 1;25(4):621-627. doi: 10.1123/japa.2015-0271. Epub 2017 Sep 19.

    PMID: 28290746BACKGROUND
  • Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Treatment for Vestibular Disorders: How Does Your Physical Therapist Treat Dizziness Related to Vestibular Problems? J Neurol Phys Ther. 2016 Apr;40(2):156. doi: 10.1097/01.NPT.0000481898.55592.6e. No abstract available.

    PMID: 26934418BACKGROUND
  • Swanenburg J, Babler E, Adelsberger R, Straumann D, de Bruin ED. Patients with chronic peripheral vestibular hypofunction compared to healthy subjects exhibit differences in gaze and gait behaviour when walking on stairs and ramps. PLoS One. 2017 Dec 18;12(12):e0189037. doi: 10.1371/journal.pone.0189037. eCollection 2017.

    PMID: 29253883BACKGROUND
  • Bukhari SA, Ghous M, Butt P, Kiyani SK, Tariq A. Comparison of exergaming and vestibular training on gaze stability, balance, and gait performance of older adults: A single blind randomized control trial. J Pak Med Assoc. 2022 Oct;72(10):1909-1912. doi: 10.47391/JPMA.3566.

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2020

First Posted

June 4, 2020

Study Start

August 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 31, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations