VestibulopathyNCT07751354
Study of Measurement Properties of QTUG in Older Adults With Vestibulopathy
A study testing Vestibular Rehabilitation in people with Vestibulopathy, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Falls can be serious for older people, sometimes even leading to trips to the hospital. It's important to find ways to help prevent falls, especially for older people. Doctors have different tests they use to figure out who might be more likely to fall. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vestibulopathy
- What is being tested?
- Vestibular Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults (aged >65)
- Diagnosis of vestibular pathology including unilateral vestibulopathy/vestibular neuritis or bilateral vestibulopathy, Meniere disease, vestibular associated migraines, PPPD, Presby vestibulopathy (PVP), vestibular paroxysmia, vestibular schwannoma, third window syndrome.
- Able to walk independently with or without walking aid.
- Able to provide consent
Who cannot join
- Visual impairment.
- Diagnosis of Benign paroxysmal positional vertigo (BPPV) or haemodynamic dizziness (Postural hypotension, cardiogenic dizziness/POTS, heart arrythmia, heart attack).
- Diagnosis of neurological disorder such as: multiple sclerosis, cerebrovascular accident, Parkinson's disease, dementia, diabetic neuropathy, epilepsy.
- Not fluent in English.
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: The Study of Measurement Properties of Quantitative Timed Up and Go (QTUG) in Older Adults With Vestibulopathy
Falls can be serious for older people, sometimes even leading to trips to the hospital. It's important to find ways to help prevent falls, especially for older people. Doctors have different tests they use to figure out who might be more likely to fall. One test they use is called the Time Up and Go (TUG) test, where a person has to stand up, walk a bit, and sit back down.
Now there's a newer version of this test called the quantitative TUG (QTUG), which uses special sensors to measure how well someone can keep their balance. But not many doctors use it yet because they're not sure how good it is compared to other tests. We want to study how good the QTUG is at measuring balance in older people with dizziness problems.
Read more
Study 1:
First, the Principal Investigator (PI) will look at data from previous routine tests done on 55 older adults seen within the regional department of Neurotology between 2018 and 2024 to see how the QTUG results match up with what the doctor already knows about balance problems.
Study 2:
Secondly, the PI will conduct a larger study with 120 older adults (+65 years) who have dizziness issues. Participants will be asked to undertake a variety of tests, including the QTUG test, 30 sec sit to stand test, and the PI will ask them questions about how they feel about their balance.
Study 3:
Sixty of the recruited 120 patients will do special exercises for six months to help improve their balance, while the other sixty will only do these exercises at the end of the study. The PI will then compare the data to see if the QTUG test can tell if exercises are helping or not.
Study 4:
Finally, the PI will recruit another 60 elderly participants to see if the QTUG test can tell who's more likely to fall over the next year. The PI will compare the results of the test to what happens to these people within a year to see how accurate the QTUG test is at predicting falls.
Using data from these studies, the PI hopes to learn if the QTUG test is a good way to measure balance problems in older people and if it can help doctors figure out who might be at risk of falling, and if the exercises are helping to prevent falls.
- Conditions
- Vestibulopathy
- Being tested
- Vestibular Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationBehavioural
60 participants will be randomised to receive vestibular rehabilitation that includes adaptive, habituation and substitution exercises; Gait retraining; Lower limb strengthening; Cervical spine treatment by a trained physiotherapist at the Royal Hallamshire Hospital Physiotherapy Department. This rehabilitation programme is delivered as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - Vestibular Rehabilitation | Experimental | 60 participants will be randomised to receive vestibular rehabilitation that includes adaptive, habituation and substitution exercises; Gait retraining; Lower limb strengthening; Cervical spine treatment by a trained physiotherapist at the Royal Hallamshire Hospital Physiotherapy Department. This rehabilitation programme is delivered as part of routine care. The other 60 will be the control group, who will have their rehabilitation programme delayed until the end of the study 4. Receives: Behavioral: Vestibular Rehabilitation |
| Control arm | No intervention | 60 participants will be randomised to the control group, who will have their rehabilitation programme delayed until the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Risk Estimate (FRE)
A statistical percentage (0% to 100%) indicating a patient's statistical risk of falling, compared to independent reference samples based on age and gender
Measured: From participant enrolment to completion of the intervention at 6 months
Frailty Index (FI)
An objective estimate (often based on Fried's frailty phenotype) that categorizes the patient's level of frailty (e.g., robust, pre-frail, or frail)
Measured: From participant enrolment to completion of the intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start12 May 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VestibulopathyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751354
- Sponsor's protocol ID
- STH23010
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Measurement Properties of Quantitative Timed Up and Go (QTUG) in Older Adults With Vestibulopathy
- ClinicalTrials.gov ID
- NCT07751354
- Acronym / sponsor ID
- STH23010
- Conditions
- Vestibulopathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 7 Aug 2026 (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.
Falls can be serious for older people, sometimes even leading to trips to the hospital. It's important to find ways to help prevent falls, especially for older people. Doctors have different tests they use to figure out who might be more likely to fall. One test they use is called the Time Up and Go (TUG) test, where a person has to stand up, walk a bit, and sit back down.
Now there's a newer version of this test called the quantitative TUG (QTUG), which uses special sensors to measure how well someone can keep their balance. But not many doctors use it yet because they're not sure how good it is compared to other tests. We want to study how good the QTUG is at measuring balance in older people with dizziness problems.
Study 1:
First, the Principal Investigator (PI) will look at data from previous routine tests done on 55 older adults seen within the regional department of Neurotology between 2018 and 2024 to see how the QTUG results match up with what the doctor already knows about balance problems.
Study 2:
Secondly, the PI will conduct a larger study with 120 older adults (+65 years) who have dizziness issues. Participants will be asked to undertake a variety of tests, including the QTUG test, 30 sec sit to stand test, and the PI will ask them questions about how they feel about their balance.
Study 3:
Sixty of the recruited 120 patients will do special exercises for six months to help improve their balance, while the other sixty will only do these exercises at the end of the study. The PI will then compare the data to see if the QTUG test can tell if exercises are helping or not.
Study 4:
Finally, the PI will recruit another 60 elderly participants to see if the QTUG test can tell who's more likely to fall over the next year. The PI will compare the results of the test to what happens to these people within a year to see how accurate the QTUG test is at predicting falls.
Using data from these studies, the PI hopes to learn if the QTUG test is a good way to measure balance problems in older people and if it can help doctors figure out who might be at risk of falling, and if the exercises are helping to prevent falls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - Vestibular Rehabilitation | Experimental | Behavioral: Vestibular Rehabilitation60 participants will be randomised to receive vestibular rehabilitation that includes adaptive, habituation and substitution exercises; Gait retraining; Lower limb strengthening; Cervical spine treatment by a trained physiotherapist at the Royal Hallamshire Hospital Physiotherapy Department. This rehabilitation programme is delivered as part of routine care. The other 60 will be the control group, who will have their rehabilitation programme delayed until the end of the study 4. |
| Control arm | No intervention | –60 participants will be randomised to the control group, who will have their rehabilitation programme delayed until the end of the study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Older adults (aged >65)
- Diagnosis of vestibular pathology including unilateral vestibulopathy/vestibular neuritis or bilateral vestibulopathy, Meniere disease, vestibular associated migraines, PPPD, Presby vestibulopathy (PVP), vestibular paroxysmia, vestibular schwannoma, third window syndrome.
- Able to walk independently with or without walking aid.
- Able to provide consent
Key exclusion criteria (5 listed)
- Visual impairment.
- Diagnosis of Benign paroxysmal positional vertigo (BPPV) or haemodynamic dizziness (Postural hypotension, cardiogenic dizziness/POTS, heart arrythmia, heart attack).
- Diagnosis of neurological disorder such as: multiple sclerosis, cerebrovascular accident, Parkinson's disease, dementia, diabetic neuropathy, epilepsy.
- Not fluent in English.
- Pregnant
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 |
|---|---|---|
| Vestibular Rehabilitation60 participants will be randomised to receive vestibular rehabilitation that includes adaptive, habituation and substitution exercises; Gait retraining; Lower limb strengthening; Cervical spine treatment by a trained physiotherapist at the Royal Hallamshire Hospital Physiotherapy Department. This rehabilitation programme is delivered as part of routine care. | Behavioural | Intervention arm - Vestibular Rehabilitation |
Primary outcome
Falls Risk Estimate (FRE)
Time frame: From participant enrolment to completion of the intervention at 6 months
A statistical percentage (0% to 100%) indicating a patient's statistical risk of falling, compared to independent reference samples based on age and gender
Frailty Index (FI)
Time frame: From participant enrolment to completion of the intervention at 6 months
An objective estimate (often based on Fried's frailty phenotype) that categorizes the patient's level of frailty (e.g., robust, pre-frail, or frail)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation in people with Vestibulopathy, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Falls Risk Estimate (FRE) (time frame: From participant enrolment to completion of the intervention at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.