Older AdultsNCT04414462
Comparison of Exergaming and Vestibular Training on Gaze Stability, Balance and Gait Performance of Older Adults.
A study testing exergaming training and training - Group II in people with Older Adults, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Older Adults
- What is being tested?
- exergaming training and training - Group II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A score of 21 and above on berg balance scale.
- A minimum head velocity of 150◦/s on dynamic visual acuity test.
Who cannot join
- Acute Musculoskeletal pain
- Uncontrollable cardiovascular disease (e.g. High blood pressure, Uncontrolled sugar)
- Weakness from known neurological problems (Parkinson's, stroke, multiple sclerosis)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan General Railway Hospital
Rawalpindi, Punjab Province, 46000
About this study
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.
Read the 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.
- Conditions
- Older Adults
- Being tested
- exergaming training, training - Group II
- Keywords
- Exergaming, vestibular training, gaze stability, Balance, Gait, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exergaming trainingOther
- 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)
training - Group IIOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I will receive following exergaming training: heading, tightrope tension,snowboard slalom and table tilt game Receives: Other: exergaming training |
| Group II | Active comparator | Group II will receive Habituation,wobble board exercises,double leg,single leg and tandem stance training. Receives: Other: training - Group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Change from Baseline gait to 6th Week
Secondary outcomes (1)
Force Platform
It provides a quantitative way to measure postural control and analysis of various aspects of balance.
Measured: Change from Baseline postural variation to 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Aug 2020
- Primary completion1 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414462
- Sponsor's protocol ID
- REC/00743 Amina bukhari
- Status last verified
- Mar 2021
- First submitted
- 30 May 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29369207Siddiqi 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.
PubMed 30804593Lee 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.
PubMed 28290746Hall 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.
PubMed 26934418Swanenburg 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.
PubMed 29253883Bukhari 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.
PubMed 36660969
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exergaming and Vestibular Training on Gaze Stability, Balance and Gait Performance of Older Adults.
- ClinicalTrials.gov ID
- NCT04414462
- Acronym / sponsor ID
- REC/00743 Amina bukhari
- Conditions
- Older Adults
- Keywords
- Exergaming, vestibular training, gaze stability, Balance, Gait, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: exergaming trainingGroup I will receive following exergaming training: heading, tightrope tension,snowboard slalom and table tilt game |
| Group II | Active comparator | Other: training - Group IIGroup II will receive Habituation,wobble board exercises,double leg,single leg and tandem stance training. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A score of 21 and above on berg balance scale.
- A minimum head velocity of 150◦/s on dynamic visual acuity test.
Key exclusion criteria (3 listed)
- Acute Musculoskeletal pain
- Uncontrollable cardiovascular disease (e.g. High blood pressure, Uncontrolled sugar)
- Weakness from known neurological problems (Parkinson's, stroke, multiple sclerosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exergaming training* 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) | Other | Group I |
| training - Group II* 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. | Other | Group II |
Primary outcome
Timed Up and Go test (TUG)
Time frame: Change from Baseline balance to 6th Weeks
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.
Dynamic Visual Acuity
Time frame: Change from Baseline vestibular ocular reflex to 6th Week
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.
Dynamic Gait Index
Time frame: Change from Baseline gait to 6th Week
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
1 secondary outcome
Force Platform
Time frame: Change from Baseline postural variation to 6th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 29369207Tomita 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.
- Background: PubMed 30804593Siddiqi 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.
- Background: PubMed 28290746Lee 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.
- Background: PubMed 26934418Hall 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.
- Background: PubMed 29253883Swanenburg 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.
- Derived from this study: PubMed 36660969Bukhari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ghous, MSNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exergaming training and training - Group II in people with Older Adults, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go test (TUG) (time frame: Change from Baseline balance to 6th Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414462, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.