Old AgeNCT06407726
Comparative Effects of Virtual Reality and Vestibular Exercises on Balance Gait in Older Adults
A study testing virtual reality training group and vestibular exercise group in people with Old Age and Vestibular Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Age, Vestibular Disorder, Balance
- What is being tested?
- virtual reality training group and vestibular exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 1 Sep 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults with or without any assistive device.
- Participants with a Mini-Mental State Examination score greater than 24.
- Participants with a value greater than 10 secs on the Time Up and Go Test.
Who cannot join
- Severe visual or vestibular impairments (e.g., Meniere's disease, labyrinthitis).
- Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
- Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
- History of epilepsy or seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Virtual Reality and Vestibular Exercises on Balance, Gait, and Activities of Daily Living in Older Adults
To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.
Read the detailed description
It will be a randomized clinical trial where non-probability convenience sampling technique will be used. Total 44 participants will be taken aged 60 to 85 years. All Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment. The Berg Balance Scale for balance assessment, Dynamic Gait Index for gait while Time Up and Go Test, and Modified Barthel Index for Activities of Daily Living will be outcome measure tools.
- Conditions
- Old Age, Vestibular Disorder, Balance, Exercise
- Being tested
- virtual reality training group, vestibular exercise group
- Keywords
- Old Age, Vestibular Disorder, Balance, Exercise
- Medical subject headings
- Vestibular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality training groupOther
Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy.
vestibular exercise groupOther
Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.
| Study group | Role | What they receive |
|---|---|---|
| participants will receive Virtual Reality intervention with conventional treatment, | Experimental | Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy. Receives: Other: virtual reality training group |
| participants will receive Vestibular Exercises with conventional treatment. | Active comparator | Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy. Receives: Other: vestibular exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dynamic Gait Index (DGI)
The Dynamic Gait Index (DGI) is a clinical tool assessing balance during walking under different external conditions. It uses a four-point ordinal scale, with a total score of 24. Scores below 19 indicate a higher risk of falls in older adults, while scores above 22 suggest safe ambulation. The DGI has demonstrated validity as a measure of functional mobility and strongly predicts falls
Measured: 6 months
Berg Balance Scale
Berg Balance Scale: is a clinical tool assessing static and dynamic balance through 14 functional tasks, each scored from 0 to 4, with a maximum score of 56. Scores below 45 indicate a higher risk of falling. It has demonstrated excellent validity, correlating well with the Timed Up-and-Go test. It also exhibits excellent test-retest reliability, making it a widely accepted tool for measuring balance and mobility.
Measured: 6 months
Modified Barthel Index
Modified Barthel Index is widely accepted measure of physical disability, assessing activities of daily living. Scoring ranges from 0 to 20, with lower scores indicating increased disability. The total score reflects the patient's independence in daily activities, with changes of more than two points indicating a probable genuine change. The index has demonstrated validity, with scores between 0.73 and 0.77 compared to a motor ability index for stroke patients.It also exhibits high inter-rater and test-retest reliability,Higher scores indicates maximum recovery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Old AgeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407726
- Sponsor's protocol ID
- REC/RCR & AHS/23/0280
- Status last verified
- Sep 2024
- First submitted
- 6 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tornero-Quinones I, Saez-Padilla J, Espina Diaz A, Abad Robles MT, Sierra Robles A. Functional Ability, Frailty and Risk of Falls in the Elderly: Relations with Autonomy in Daily Living. Int J Environ Res Public Health. 2020 Feb 5;17(3):1006. doi: 10.3390/ijerph17031006.
PubMed 32033397Nobrega-Sousa P, Gobbi LTB, Orcioli-Silva D, Conceicao NRD, Beretta VS, Vitorio R. Prefrontal Cortex Activity During Walking: Effects of Aging and Associations With Gait and Executive Function. Neurorehabil Neural Repair. 2020 Oct;34(10):915-924. doi: 10.1177/1545968320953824. Epub 2020 Aug 31.
PubMed 32865134Lockie RG, Dawes JJ, Kornhauser CL, Holmes RJ. Cross-Sectional and Retrospective Cohort Analysis of the Effects of Age on Flexibility, Strength Endurance, Lower-Body Power, and Aerobic Fitness in Law Enforcement Officers. J Strength Cond Res. 2019 Feb;33(2):451-458. doi: 10.1519/JSC.0000000000001937.
PubMed 28445229
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Virtual Reality and Vestibular Exercises on Balance, Gait, and Activities of Daily Living in Older Adults
- ClinicalTrials.gov ID
- NCT06407726
- Acronym / sponsor ID
- REC/RCR & AHS/23/0280
- Conditions
- Old Age, Vestibular Disorder, Balance, Exercise
- Keywords
- Old Age, Vestibular Disorder, Balance, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 May 2024 (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.
To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.
Detailed description
It will be a randomized clinical trial where non-probability convenience sampling technique will be used. Total 44 participants will be taken aged 60 to 85 years. All Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment. The Berg Balance Scale for balance assessment, Dynamic Gait Index for gait while Time Up and Go Test, and Modified Barthel Index for Activities of Daily Living will be outcome measure tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment.
| Arm | Type | Receives |
|---|---|---|
| participants will receive Virtual Reality intervention with conventional treatment, | Experimental | Other: virtual reality training groupParticipants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy. |
| participants will receive Vestibular Exercises with conventional treatment. | Active comparator | Other: vestibular exercise groupParticipants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older adults with or without any assistive device.
- Participants with a Mini-Mental State Examination score greater than 24.
- Participants with a value greater than 10 secs on the Time Up and Go Test.
Key exclusion criteria (4 listed)
- Severe visual or vestibular impairments (e.g., Meniere's disease, labyrinthitis).
- Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
- Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
- History of epilepsy or seizures.
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 |
|---|---|---|
| virtual reality training groupParticipants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy. | Other | participants will receive Virtual Reality intervention with conventional treatment, |
| vestibular exercise groupParticipants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy. | Other | participants will receive Vestibular Exercises with conventional treatment. |
Primary outcome
The Dynamic Gait Index (DGI)
Time frame: 6 months
The Dynamic Gait Index (DGI) is a clinical tool assessing balance during walking under different external conditions. It uses a four-point ordinal scale, with a total score of 24. Scores below 19 indicate a higher risk of falls in older adults, while scores above 22 suggest safe ambulation. The DGI has demonstrated validity as a measure of functional mobility and strongly predicts falls
Berg Balance Scale
Time frame: 6 months
Berg Balance Scale: is a clinical tool assessing static and dynamic balance through 14 functional tasks, each scored from 0 to 4, with a maximum score of 56. Scores below 45 indicate a higher risk of falling. It has demonstrated excellent validity, correlating well with the Timed Up-and-Go test. It also exhibits excellent test-retest reliability, making it a widely accepted tool for measuring balance and mobility.
Modified Barthel Index
Time frame: 6 months
Modified Barthel Index is widely accepted measure of physical disability, assessing activities of daily living. Scoring ranges from 0 to 20, with lower scores indicating increased disability. The total score reflects the patient's independence in daily activities, with changes of more than two points indicating a probable genuine change. The index has demonstrated validity, with scores between 0.73 and 0.77 compared to a motor ability index for stroke patients.It also exhibits high inter-rater and test-retest reliability,Higher scores indicates maximum recovery
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 19 Sep 2024.
- Background: PubMed 32033397Tornero-Quinones I, Saez-Padilla J, Espina Diaz A, Abad Robles MT, Sierra Robles A. Functional Ability, Frailty and Risk of Falls in the Elderly: Relations with Autonomy in Daily Living. Int J Environ Res Public Health. 2020 Feb 5;17(3):1006. doi: 10.3390/ijerph17031006.
- Background: PubMed 32865134Nobrega-Sousa P, Gobbi LTB, Orcioli-Silva D, Conceicao NRD, Beretta VS, Vitorio R. Prefrontal Cortex Activity During Walking: Effects of Aging and Associations With Gait and Executive Function. Neurorehabil Neural Repair. 2020 Oct;34(10):915-924. doi: 10.1177/1545968320953824. Epub 2020 Aug 31.
- Background: PubMed 28445229Lockie RG, Dawes JJ, Kornhauser CL, Holmes RJ. Cross-Sectional and Retrospective Cohort Analysis of the Effects of Age on Flexibility, Strength Endurance, Lower-Body Power, and Aerobic Fitness in Law Enforcement Officers. J Strength Cond Res. 2019 Feb;33(2):451-458. doi: 10.1519/JSC.0000000000001937.
- 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.
Zeest hashmi, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality training group and vestibular exercise group in people with Old Age and Vestibular Disorder, 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 3 inclusion and 4 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 19 Sep 2024. 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?
The Dynamic Gait Index (DGI) (time frame: 6 months). 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 NCT06407726, which also lists 3 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 19 Sep 2024.