- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414462
Comparison of Exergaming and Vestibular Training on Gaze Stability, Balance and Gait Performance of Older Adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to a recent report by 2050, the global adult population between the age 65 and above is expected to increase to 28%. A total of 12.13 million people in Pakistan are above age of 60, which is expected to raise to 17.53 million by 2025. A high quality of life as well as longevity is considered important in older adults.However, characteristics of aging include a decrease in muscle strength, balance and decreased vestibular functions can lead to falls and compromise good health in older adults.
Vestibular rehabilitation is an exercised based program intended to alleviate both primary and secondary problems caused by vestibular disorders.The main focus of vestibular rehabilitation is to use the existing vestibular system for gaze, postural stability and gait by use of somatosensory and visual cues. Depending on the vestibular disorders three main types of exercises are used. Habituation Gaze stability exercises ,Balance training. Habituation exercises are indicated for patients who complain of dizziness during quick head movements and when they change position like when they bend over or look up to reach above their head. The goal of habituation exercise is to reduce the dizziness through repeated exposure to specific movements or visual stimuli that provoke patient's dizziness.
Gaze stability exercises include eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, vestibular-ocular reflex exercise. These exercises improve the static balance control thus improves postural control required for vestibular function and can be mediated by VSR improvements. These exercises are useful in bilateral vestibular hypofunction. Balance training are used to improve standing, bending, reaching and performance of dual tasks on even and uneven surfaces. These exercises proved to be effective in making individuals do activities of daily livings and prevents the risks of falls.
Computer based technology is becoming popular in rehabilitation. It stimulates learning in real-life environment and provides a 3-dimensional sensory feedback. A computer-generated technology allows the user to interact with a virtual world and to make correction during performing an exercise task. In particular, previous studies have suggested that new technology, such as the Wii Fit Board (WFB) can be used for balance training using virtual reality These games have showed repeated good results in vestibular rehabilitation of elderly.Virtual reality enables the individual to be physically active and provides a pleasant and motivating way of training in these individuals.
There are literature for the safe and effective use of exergaming in improving gaze stability, balance and postural control in older individuals Jaap Swanenburg et al concluded that exergaming is effective in improving gaze stability, balance and postural control in older adults .Lynne M Taylor showed that active video games proved to be effective in improving balance and gait in older individuals .J Hashim concluded that Exergames improved dynamic balance in older adults when compared with conventional exercises.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Pakistan General Railway Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A score of 21 and above on berg balance scale.
- A minimum head velocity of 150◦/s on dynamic visual acuity test.
Exclusion Criteria:
- Acute Musculoskeletal pain
- Uncontrollable cardiovascular disease (e.g. High blood pressure, Uncontrolled sugar)
- Weakness from known neurological problems (Parkinson's, stroke, multiple sclerosis)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group I
Group I will receive following exergaming training: heading, tightrope tension,snowboard slalom and table tilt game
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Active Comparator: Group II
Group II will receive Habituation,wobble board exercises,double leg,single leg and tandem stance training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go test (TUG)
Time Frame: Change from Baseline balance to 6th Weeks
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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.
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Change from Baseline balance to 6th Weeks
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Dynamic Visual Acuity
Time Frame: Change from Baseline vestibular ocular reflex to 6th Week
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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.
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Change from Baseline vestibular ocular reflex to 6th Week
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Dynamic Gait Index
Time Frame: Change from Baseline gait to 6th Week
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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
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Change from Baseline gait to 6th Week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Force Platform
Time Frame: Change from Baseline postural variation to 6th Week
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It provides a quantitative way to measure postural control and analysis of various aspects of balance.
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Change from Baseline postural variation to 6th Week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Misbah Ghous, MSNMPT, RIPHAH INTERNATIONAL UNIVERSITY ISLAMABAD
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/00743 Amina bukhari
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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