Study of Measurement Properties of QTUG in Older Adults With Vestibulopathy

NCT07751354 | Enrolling By Invitation

• 1 other identifier: STH23010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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 Now there's a newer version of this test called the quantitative TUG (QTUG), which uses special sensors to measure how well someone can keep their balance.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.

Conditions

Vestibulopathy

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  From participant enrolment to completion of the intervention at 6 months

Study Arms (2)

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.

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

Interventions

Vestibular Rehabilitation BEHAVIORAL

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.

Intervention arm - Vestibular Rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: August 7, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)