Vestibular Function DisorderNCT06797141
Combined Effects of Vestibular Rehabilitation With Dual Task Training in Vestibular Disorders
A study testing Vestibular Rehabilitation and Dual task Training and Traditional Physical Therapy and Vestibular Rehabilitation and Traditional Physical Therapy in people with Vestibular Function Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Patients with vestibular disorders often experience cognitive-motor interference which can adversely affect their motor performance, significantly impair daily functioning, increase instability, reducing quality of life and increasing the risk of falls. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Vestibular Function Disorder
- What is being tested?
- Vestibular Rehabilitation and Dual task Training and Traditional Physical Therapy and Vestibular Rehabilitation and Traditional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 1 Jul 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients complaining of dizziness for longer than 3 months
- Patients with history of at least 1 bout of dizziness per month
- Patients with history of at least 1 fall in previous 6 months
- Diagnosed Patients as having vestibular disorder by an otolaryngologist
- Mini Mental State Examination (MMSE) score greater than 24
Who cannot join
- Patients with Meniere disease and bilateral vestibular disorders
- Patients with central nervous system disorders, and psychiatric disorders
- Patients having visual impairment that could not be treated with lenses or glasses
- Dizziness not resulting from vestibular disorder or use of Medication for Dizziness
- Movement limitation due to orthopedic problems
- Those who were unable to sign informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Effects of Vestibular Rehabilitation and Dual Task Training Exercises on Balance, Gait and Quality of Life in Patients With Vestibular Disorders
Patients with vestibular disorders often experience cognitive-motor interference which can adversely affect their motor performance, significantly impair daily functioning, increase instability, reducing quality of life and increasing the risk of falls. Vestibular rehabilitation is a well-established therapeutic approach for managing vestibular disorders in reducing symptoms and improving balance and mobility. Similarly, Dual Task Training improves cognitive-motor integration by enhancing both cognitive and motor functions and has shown promising results in other populations. This study is aimed to determine the combined effects of both interventions as it might provide a more comprehensive and effective treatment, ultimately improving patient outcomes and quality of life.
Read the detailed description
In previous studies, vestibular rehabilitation is well-documented in enhancing balance, gait, reducing dizziness and improving quality of life through specific exercises aimed at improving vestibular function. Similarly, dual task training has shown promise in improving functional mobility and cognitive processing. However, no randomized control trial to date has systematically investigated the potential synergistic effects of these two interventions when applied together which leaves a critical gap in understanding whether the integration of dual task training into vestibular rehabilitation could yield superior outcomes for patients suffering from vestibular disorders. This research could provide valuable insights and potentially enhance therapeutic strategies for this population.
- Conditions
- Vestibular Function Disorder
- Being tested
- Vestibular Rehabilitation and Dual task Training and Traditional Physical Therapy, Vestibular Rehabilitation and Traditional Physical Therapy
- Keywords
- Vestibular Disorders, Vestibular Rehabilitation, Dual Task Exercises, Quality of Life, Gait
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation and Dual task Training and Traditional Physical TherapyOther
Group A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes. Treatment session will be given 5 days per week for 8 weeks. Patients will be instructed to perform 2 sets of 5 repetition each Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Dual Task exercises comprising of primary and secondary tasks Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down
Vestibular Rehabilitation and Traditional Physical TherapyOther
Group B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be given 5 days per week for 8 weeks.
Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation and Dual Task Training and Traditional Physical Therapy | Experimental | Group A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes. Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks Receives: Other: Vestibular Rehabilitation and Dual task Training and Traditional Physical Therapy |
| Vestibular Rehabilitation and Traditional Physical Therapy | Active comparator | Group B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks. Receives: Other: Vestibular Rehabilitation and Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test
The instrument is used to assess dynamic balance including pace, distance, mechanism of turn, type of chair and number of trials. The time required to perform this test is measured. If more than 12 sec is taken in the completion of this test then it indicates high risk of fall
Measured: 8 week
Dynamic Gait Index
Dynamic Gait Index (DGI) contains eight items measured on 4-point ordinal scale (3: Normal, 2: Mild Impairment, 1: Moderate impairment, 0: Severe Impairment).
Measured: 8 week
Vestibular Rehabilitation Benefit Questionnaire
The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is 22 items subjective tool used to evaluate vestibular symptoms and their impact on quality of life in vestibular disorders. It is categorized into 3 subscales Dizziness and anxiety, Motion-provoked dizziness and Quality of life. Its score interpretation indicates 0%: no deficit \& 100%: significant deficit. Score above 0% signifies the presence of symptoms, loss of function, or reduced quality of life
Measured: 8 week
Secondary outcomes (1)
Dizziness Handicap Inventory
It is a 25 item self-reported tool used to assess the level of disability experienced by individuals with dizziness, vertigo, or imbalance. It evaluates the impact of dizziness on functional, emotional, and physical aspects of the individual's life. It takes only 10 minutes to complete this tool. Patients rate their perceived disability due to dizziness by responding to each question with "yes," "sometimes," or "no." The answers are scored as follows: "No" = 0 points, "Sometimes" = 2 points, and "Yes" = 4 points. A higher total score, out of a possible 100 points, indicates a greater level of perceived disability. Patients scoring over 10 points should be referred for further evaluation.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Nov 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vestibular Function DisorderStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797141
- Sponsor's protocol ID
- REC/RCR & AHS/24/0257
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi WY, Gold DR. Vestibular Disorders: Pearls and Pitfalls. Semin Neurol. 2019 Dec;39(6):761-774. doi: 10.1055/s-0039-1698752. Epub 2019 Dec 17.
PubMed 31847047Aedo-Sanchez C, Riquelme-Contreras P, Henriquez F, Aguilar-Vidal E. Vestibular dysfunction and its association with cognitive impairment and dementia. Front Neurosci. 2024 Mar 27;18:1304810. doi: 10.3389/fnins.2024.1304810. eCollection 2024.
PubMed 38601091Strupp M, Dlugaiczyk J, Ertl-Wagner BB, Rujescu D, Westhofen M, Dieterich M. Vestibular Disorders. Dtsch Arztebl Int. 2020 Apr 24;117(17):300-310. doi: 10.3238/arztebl.2020.0300.
PubMed 32530417Staab JP. Persistent Postural-Perceptual Dizziness. Semin Neurol. 2020 Feb;40(1):130-137. doi: 10.1055/s-0039-3402736. Epub 2020 Jan 14.
PubMed 31935771
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Vestibular Rehabilitation and Dual Task Training Exercises on Balance, Gait and Quality of Life in Patients With Vestibular Disorders
- ClinicalTrials.gov ID
- NCT06797141
- Acronym / sponsor ID
- REC/RCR & AHS/24/0257
- Conditions
- Vestibular Function Disorder
- Keywords
- Vestibular Disorders, Vestibular Rehabilitation, Dual Task Exercises, Quality of Life, Gait
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
Patients with vestibular disorders often experience cognitive-motor interference which can adversely affect their motor performance, significantly impair daily functioning, increase instability, reducing quality of life and increasing the risk of falls. Vestibular rehabilitation is a well-established therapeutic approach for managing vestibular disorders in reducing symptoms and improving balance and mobility. Similarly, Dual Task Training improves cognitive-motor integration by enhancing both cognitive and motor functions and has shown promising results in other populations. This study is aimed to determine the combined effects of both interventions as it might provide a more comprehensive and effective treatment, ultimately improving patient outcomes and quality of life.
Detailed description
In previous studies, vestibular rehabilitation is well-documented in enhancing balance, gait, reducing dizziness and improving quality of life through specific exercises aimed at improving vestibular function. Similarly, dual task training has shown promise in improving functional mobility and cognitive processing. However, no randomized control trial to date has systematically investigated the potential synergistic effects of these two interventions when applied together which leaves a critical gap in understanding whether the integration of dual task training into vestibular rehabilitation could yield superior outcomes for patients suffering from vestibular disorders. This research could provide valuable insights and potentially enhance therapeutic strategies for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation and Dual Task Training and Traditional Physical Therapy | Experimental | Other: Vestibular Rehabilitation and Dual task Training and Traditional Physical TherapyGroup A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes. Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks |
| Vestibular Rehabilitation and Traditional Physical Therapy | Active comparator | Other: Vestibular Rehabilitation and Traditional Physical TherapyGroup B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients complaining of dizziness for longer than 3 months
- Patients with history of at least 1 bout of dizziness per month
- Patients with history of at least 1 fall in previous 6 months
- Diagnosed Patients as having vestibular disorder by an otolaryngologist
- Mini Mental State Examination (MMSE) score greater than 24
Key exclusion criteria (6 listed)
- Patients with Meniere disease and bilateral vestibular disorders
- Patients with central nervous system disorders, and psychiatric disorders
- Patients having visual impairment that could not be treated with lenses or glasses
- Dizziness not resulting from vestibular disorder or use of Medication for Dizziness
- Movement limitation due to orthopedic problems
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 Rehabilitation and Dual task Training and Traditional Physical TherapyGroup A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes. Treatment session will be given 5 days per week for 8 weeks. Patients will be instructed to perform 2 sets of 5 repetition each Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Dual Task exercises comprising of primary and secondary tasks Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down | Other | Vestibular Rehabilitation and Dual Task Training and Traditional Physical Therapy |
| Vestibular Rehabilitation and Traditional Physical TherapyGroup B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be given 5 days per week for 8 weeks. Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down | Other | Vestibular Rehabilitation and Traditional Physical Therapy |
Primary outcome
Timed Up and Go test
Time frame: 8 week
The instrument is used to assess dynamic balance including pace, distance, mechanism of turn, type of chair and number of trials. The time required to perform this test is measured. If more than 12 sec is taken in the completion of this test then it indicates high risk of fall
Dynamic Gait Index
Time frame: 8 week
Dynamic Gait Index (DGI) contains eight items measured on 4-point ordinal scale (3: Normal, 2: Mild Impairment, 1: Moderate impairment, 0: Severe Impairment).
Vestibular Rehabilitation Benefit Questionnaire
Time frame: 8 week
The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is 22 items subjective tool used to evaluate vestibular symptoms and their impact on quality of life in vestibular disorders. It is categorized into 3 subscales Dizziness and anxiety, Motion-provoked dizziness and Quality of life. Its score interpretation indicates 0%: no deficit \& 100%: significant deficit. Score above 0% signifies the presence of symptoms, loss of function, or reduced quality of life
1 secondary outcome
Dizziness Handicap Inventory
Time frame: 8 week
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 28 Jan 2025.
- Background: PubMed 31847047Choi WY, Gold DR. Vestibular Disorders: Pearls and Pitfalls. Semin Neurol. 2019 Dec;39(6):761-774. doi: 10.1055/s-0039-1698752. Epub 2019 Dec 17.
- Background: PubMed 38601091Aedo-Sanchez C, Riquelme-Contreras P, Henriquez F, Aguilar-Vidal E. Vestibular dysfunction and its association with cognitive impairment and dementia. Front Neurosci. 2024 Mar 27;18:1304810. doi: 10.3389/fnins.2024.1304810. eCollection 2024.
- Background: PubMed 32530417Strupp M, Dlugaiczyk J, Ertl-Wagner BB, Rujescu D, Westhofen M, Dieterich M. Vestibular Disorders. Dtsch Arztebl Int. 2020 Apr 24;117(17):300-310. doi: 10.3238/arztebl.2020.0300.
- Background: PubMed 31935771Staab JP. Persistent Postural-Perceptual Dizziness. Semin Neurol. 2020 Feb;40(1):130-137. doi: 10.1055/s-0039-3402736. Epub 2020 Jan 14.
- 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.
Hira Jabeen, PhD 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 Vestibular Rehabilitation and Dual task Training and Traditional Physical Therapy and Vestibular Rehabilitation and Traditional Physical Therapy in people with Vestibular Function 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 5 inclusion and 6 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 28 Jan 2025. 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?
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?
Timed Up and Go test (time frame: 8 week). 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 NCT06797141, which also lists 4 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 28 Jan 2025.